Marketing

Sanofi US

Senior Manager Regulatory Affairs Advertising and Promotion

**Job title:** Senior Manager Regulatory Affairs Advertising and Promotion

- **Location:** Morristown, NJ/Cambridge, MA

**About the job**

As the Senior Manager, Regulatory Affairs Advertising and Promotionwithin our GRA Advertising and Promo Team, you will be responsible for conducting the independent review of advertising, promotional, communications and other materials, and help develop and implement regulatory strategies for promotion and advertising campaigns. Ready to get started?

With some direction from the Therapeutic Area Head, will conduct the independent review of advertising, promotional, communications and other materials, and help develop and implement regulatory strategies for promotion and advertising campaigns, including serving as regulatory lead for product launches. As the product A&P expert, contribute to the development and implementation of regulatory strategies for labeling, product defense, and development projects. Serve as the primary liaison with FDA, for assigned products, on matters related to advertising and promotional compliance matters.

Join the engine of Sanofis mission where deep immunoscience meets bold, AI-powered research. In R&D, youll drive breakthroughs that could turn the impossible into possible for millions.

**About Sanofi:**

Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve peoples lives.

**Main Responsibilities:**

- Identifies product-specific or therapeutic area A&P issues and works with other teams to propose and implement solutions.
- Identifies different strategies for addressing issues; advises of risk/benefit of each and assists clients with making sound business decisions with the understanding of the potential risk/benefits with respect to intervening regulatory matters.
- Oversees and bears responsibility for the successful implementation of regulatory strategic objectives and projects with minimal supervision.
- Active participant and Regulatory representative on brand teams and Review Committees (RC) for commercial and medical materials, respectively.
- Provides guidance and feedback to internal Sanofi constituencies (commercial groups, R&D) to maximize the competitive impact of product development as well as ultimate promotion, advertising, and reimbursement. Provides input to the Global organization on domestic regulatory strategies for in-line products through life cycle management programs.
- Contribute A&P expertise to the development of optimal labeling on new and supplemental new drug applications.
- Provides product-specific Regulatory strategies to mitigate risk; works in conjunction with brand team management to provide advice and risk/benefit analysis to maximize value to stakeholders.
- Performs other duties as assigned.

**About You:**

**Basic Education Qualifications:**

- Bachelors degree from an accredited four-year college or university; Science focus preferred but not required.

**Work Experience Required:**

- 3+ Years experience in the within pharmaceutical or medical device advertising and promotional review.
- Successful track record with ideally 1-3 years relevant regulatory experience.
- Dealt effectively with cross-functional groups, which may include Medical, Legal, Marketing etc.

**Knowledge, Skills and Equivalent Experience:**

- Knowledge and understanding of complex medical and scientific subject matter.
- Ability to work well within cross-functional teams.
- Demonstrates solid oral communication and writing skills.
- Understanding of the U.S. pharmaceutical marketplace, and familiarity with medical terminology.
- Understands issues, problems and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution.
- Develops collaborative relationships to facilitate the accomplishment of work goals.
- Develops and proposes innovative solutions in work situations, trying different and novel ways to deal with work problems and opportunities.
- Shows ability to use appropriate interpersonal styles and techniques to gain acceptance of ideas or plans.
- Can build collaborative internal networks to obtain cooperation.
- Unquestionable ethics, professional integrity and personal values consistent with the Sanofi values.
- Is able to balance projects with day-to-day duties, ensuring participation from other members of the department as needed.
- Is able to establish priorities and timelines to effectively manage workload. Is able to multi-task well.
- Deals with people in an honest and forthright manner representing information and data accurately.

**Why Choose Us?**

- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave.
- Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.
- Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.
- Help improve the lives of millions of people globally by making drug development quicker and more effective.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

\#GD-SG #LI-GZ

\#LI-Hybrid

\#vhd

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can [be found here.](<https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi>)

New Jersey

**Job title:** Senior Manager, Regulatory Affairs Advertising and Promotion

**Location:** Morristown, NJ/Cambridge, MA

**About the job**

As the Senior Manager, Regulatory Affairs Advertising and Promotionwithin our GRA Advertising and Promo Team, you will be responsible for conducting the independent review of advertising, promotional, communications and other materials, and help develop and implement regulatory strategies for promotion and advertising campaigns. Ready to get started?

Join the engine of Sanofis mission where deep immunoscience meets bold, AI-powered research. In R&D, youll drive breakthroughs that could turn the impossible into possible for millions.

With some direction from the Therapeutic Area Head, will conduct the independent review of advertising, promotional, communications and other materials, and help develop and implement regulatory strategies for promotion and advertising campaigns, including serving as regulatory lead for product launches. As the product A&P expert, contribute to the development and implementation of regulatory strategies for labeling, product defense, and development projects. Serve as the primary liaison with FDA, for assigned products, on matters related to advertising and promotional compliance matters.

**About Sanofi**

Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve peoples lives.

**Main Responsibilities:**

- Identifies product-specific or therapeutic area A&P issues and works with other teams to propose and implement solutions.
- Identifies different strategies for addressing issues; advises of risk/benefit of each and assists clients with making sound business decisions with the understanding of the potential risk/benefits with respect to intervening regulatory matters.
- Oversees and bears responsibility for the successful implementation of regulatory strategic objectives and projects with minimal supervision.
- Active participant and Regulatory representative on brand teams and Review Committees (RC) for commercial and medical materials, respectively.
- Provides guidance and feedback to internal Sanofi constituencies (commercial groups, R&D) to maximize the competitive impact of product development as well as ultimate promotion, advertising, and reimbursement. Provides input to the Global organization on domestic regulatory strategies for in-line products through life cycle management programs.
- Contribute A&P expertise to the development of optimal labeling on new and supplemental new drug applications.
- Provides product-specific Regulatory strategies to mitigate risk; works in conjunction with brand team management to provide advice and risk/benefit analysis to maximize value to stakeholders.
- Performs other duties as assigned.

**About You**

**Basic Qualifications:**

- Bachelors degree from an accredited four-year college or university; Science focus preferred, but not require

**Work Experience Required:**

- 3+ Years experience within pharmaceutical or medical device advertising and promotional review.
- Successful track record with relevant regulatory experience.
- Dealt effectively with cross-functional groups, which may include Medical, Legal, Marketing etc.

**Knowledge, Skills and Equivalent Experience:**

- Knowledge and understanding of complex medical and scientific subject matter.
- Ability to work well within cross-functional teams.
- Demonstrates solid oral communication and writing skills.
- Understanding of the U.S. pharmaceutical marketplace, and familiarity with medical terminology.
- Understands issues, problems and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution.
- Develops collaborative relationships to facilitate the accomplishment of work goals.
- Develops and proposes innovative solutions in work situations, trying different and novel ways to deal with work problems and opportunities.
- Shows ability to use appropriate interpersonal styles and techniques to gain acceptance of ideas or plans.
- Can build collaborative internal networks to obtain cooperation.
- Unquestionable ethics, professional integrity and personal values consistent with the Sanofi values.
- Is able to balance projects with day-to-day duties, ensuring participation from other members of the department as needed.
- Is able to establish priorities and timelines to effectively manage workload. Is able to multi-task well.
- Deals with people in an honest and forthright manner representing information and data accurately.

**Why Choose Us?**

- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave.
- Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.
- Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.
- Help improve the lives of millions of people globally by making drug development quicker and more effective.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

\#GD-SA #LI-SA

\#LI-Hybrid

\#vhd

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can [be found here.](<https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi>)

Thought Leader Liaison US, Oncology, Southern California, CO, UT, NM, AZ

**Job title:** Thought Leader Liaison, U.S, Southern California, CO, UT, NM, AZ

**Location:** Remote, US (Geography: Southern California, CO, UT, NM, AZ)

**About the Job:**

Sanofi-Genzymes Thought Leader Liaison is expected to possess a high level of clinical and customer knowledge, have experience with both field and headquarters protocols and procedures, and possess drive and spirit to engage and influence health care professionals to help build educational platforms and inform the execution of current and future brand and disease-state strategies.

The Thought Leader Liaison (TLL), U.S. Hematologic Oncology and Transplant role is a field-based, marketing role that works closely with multiple myeloma Key Opinion Leaders (KOLs) as well as Oncology Nurses to ensure cross-functional commercial resources are made available as appropriate. The TLL will also work closely, and within approved SOPs, with the other field professionals, including but not limited to RBDs (Regional Business Director), ABMs (Area Business Manager) and MSLs; in addition to home office-based colleagues in Marketing, Medical Affairs, Sales, and Market Access.

Behaviors that are critical for success in this role are collaboration, communication, planning, relationship building, and the ability to execute tactical initiatives and provide timely feedback. TLLs will report to the U.S. Hematologic Oncology and Transplant Lead.

Join the team transforming care for people with immune challenges, rare diseases, cancers, and neurological conditions. In Specialty Care, youll help deliver breakthrough treatments that bring hope to patients with some of the highest unmet needs.

**About Sanofi:**

Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve peoples lives.

**Main Responsibilities**:

The TLL job responsibilities are focused in three key areas. All TLL interactions are on-label and consistent with commercial compliance, legal and regulatory guidelines.

**KOL Engagement and Advocacy Development:**

- Align with cross functional teammates, to orchestrate resources with the top KOLs, as determined by Brand Team through influence and centers of excellence mapping
- Identify, profile, cultivate and maintain long-term relationships with KOLs within the oncology community
- Engage in on-label conversations focused on topics such as product, disease state, and company, at appropriate venues
- Execute unique, on-label, and approved KOL programming (e.g. disease state and product) as directed by leadership
- Partners with national, state, and local nursing organizations to support education on specific disease states
- Compliantly collaborate and communicate with the field team on each assigned KOL, to ensure strategic and tactical cohesiveness
- Serve as single point of contact to resolve KOL issues
- Execute a customer centric needs based approach with targeted KOLs
- Plan and execute KOL engagements and executive encounters at local, regional and national conferences; POAs; field visits, and other venues as directed in a compliant manner

**Market Insights:**

- Capture feedback derived from brand needs through live interactions with targeted customers and KOLs
- Work with targeted KOLs to obtain feedback on new and existing brand-related marketing strategies/materials (all materials and programs a TLL will request feedback will be approved by legal, compliance and regulatory)
- Participate as member of cross-functional brand team(s) to provide feedback on strategy, messaging, and tactical execution and novel programming ideas and concepts
- Provide competitive intelligence gained through interactions to help shape strategy.
- Facilitate cross-functional planning, recruitment, and execution of regional and national advisory boards, capturing feedback to inform brand decisions.
- Identify, align, and recruit appropriate HCP consultants to engage to meet the need profiled by marketing leaders to meet the organizational goal for each project.

**Speaker Bureau Operations and Content:**

- Assist with on-label KOL development, including identification and/or training/coaching of promotional speakers with approved slide decks and materials for MDs, PharmDs, and Nurses
- Assist in the execution of speaker contracting when requested, including but not limited to completion annual budget plan, recommendations and nominations, tiering, debarring, FMV, and contract execution
- Compliantly train speakers on approved promotional slide decks, and assist with completion of annual compliance training
- Plan and execute annual speaker training summit, and ensure speakers are updated on any content changes prior to program execution
- Attend all live HCP TLL region programming to observe, coach, and remediate the speaker where necessary to ensure compliant execution of content
- Assist with new content creation and existing content updates and annual renewals
- Manage monthly reporting on Speaker Program KPIs and field force performance
- Serve as the single point of contact for high volume speaker logistic / scheduling and working cross functionally to ensure appropriate communication
- Lead planning, execution and pull-through of GPO in-practice programs

**About You:**

Basic Qualifications:

- Bachelor's degree
- A minimum of four years of work experience in one or more of the following: field sales, product marketing, or medical / clinical experience in the same or related therapeutic area within the pharmaceutical / biotech industry
- Strong organizational skills
- Ability to travel to meetings/trainings/programs as necessary
- Valid driver's license
- Must reside within the geographic area of the assigned territory, or within a reasonable distance as determined by leadership
- 60% - 75% travel likely; could be less based on geography

Preferred Qualifications:

- Master's degree in related field
- Oncology experience
- Demonstrated leadership skills
- Multiple myeloma experience
- Launch experience
- Marketing experience
- Ability to assemble and lead cross-functional teams toward a shared vision of success
- Ability to present ideas effectively to individuals or groups, targeting presentation to the needs of the audience
- Infusion product experience a plus
- Strong project management experience, including superior analytical and planning skills
- Ability to manage multiple projects simultaneously
- Ability to execute against strategic and tactical plans under tight timelines

**Preferred Qualifications:**

- Master's degree in related field
- Multiple myeloma experience
- Launch experience
- Marketing experience
- Infusion product experience a plus

**Why Choose Us?**

- Make your work count by supporting a company that brings life-changing treatments to millions and is committed to doing right by patients, communities, and the planet.
- Drive progress from within by helping simplify, scale, and modernize how a global biopharma business delivers smarter, faster, and more sustainably.
- Support teams across science, medicine, and operations by building better systems, shaping bold strategies, and enabling innovation at speed.
- Make an impact across borders and functions, collaborating with leaders to turn complex challenges into real-world solutions.
- Advance your career through stretch roles, cross-functional moves, and development opportunities designed to match your ambition.
- Thrive in inclusive, high-performing teams where every role matters and every voice helps shape whats next.

Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

\#GD-SG

\#LI-GZ

\#LI-Remote

\#vhd

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can [be found here.](<https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi>)

Nationwide

Assistant General Counsel Policy, Strategy & Litigation

**Job Title**: Assistant General Counsel Policy, Strategy & Litigation

- Location: Washington, DC/Morristown, NJ/Cambridge, MA

**About the Job**

Ready to push the limits of whats possible? Join Sanofi in one of our corporate functions and you can play a vital part in the performance of our entire business while helping to make an impact on millions around the world.

This is a senior, high-visibility strategic legal role within Sanofis LEBI organization. The Assistant General Counsel Policy, Strategy & Litigation will help shape how Sanofis Law Division engages the external policy and legal environment that governs how its medicines are priced, purchased, distributed, reimbursed, and accessed. This is not a role that owns a single program it is a role that helps the Law Division think and act strategically across the full landscape of U.S. government pricing and drug pricing reform, including the 340B Drug Pricing Program, PBM reform, Most Favored Nation (MFN) implementation, IRA drug price negotiation, and related federal and state policy developments.

This role reports to the Head of Market Access Legal and will partner closely with the business, the North America General Counsel, the Head of Litigation, the Head of Public Policy & Corporate Affairs, and Communications among others to define Sanofis internal positions, shape affirmative litigation and advocacy strategy, and help design and defend internal programs that advance Sanofis interests and the interests of patients. The role will also maintain day-to-day responsibility for a portion of Sanofis 340B program implementation, providing a concrete operational anchor for the broader strategic mandate. This is a rare opportunity to help build a strategic capability at the center of the Law Division translating legal analysis into positions, programs, and advocacy that shift the external environment in Sanofis favor.

**About Sanofi:**

Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives.

**Main Responsibilities**

*Policy Strategy & Environment Shaping:*

- Help define Sanofis internal legal positions on the drug pricing and government program issues that matter most to the business and the patients it serves including 340B, PBM reform, MFN implementation, and government pricing programs more broadly (Medicaid Drug Rebate Program, Federal Supply Schedule, Medicare Part B/Part D).

- Partner with the Head of Market Access Legal, the North America General Counsel, the Head of Litigation, and the Head of Public Policy & Corporate Affairs among others to develop the Law Divisions environment-shaping strategy identifying where legal, policy, and advocacy tools can be used together to favorably position Sanofis medicines and the broader industry.

- Monitor and analyze federal and state legislative, regulatory, and litigation developments affecting drug pricing, government programs, and access, and translate that analysis into actionable recommendations for senior leadership.

*340B Program Implementation:*

- Serve as day-to-day legal lead on a defined portion of Sanofis 340B program implementation, including aspects of the 340B Integrity Initiative and Credit Model.

- Manage or support 340B HRSA Administrative Dispute Resolution (ADR) proceedings and related federal and state legal matters, in coordination with the Litigation team.

- Maintain current legal positions on key 340B interpretive questions covered entity eligibility, patient definition, contract pharmacy arrangements, orphan drug exclusions, duplicate discounts, and diversion and ensure they are reflected consistently in Sanofis broader policy and litigation strategy.

*Affirmative Litigation & Strategy:*

- Proactively identify, assess, and help develop affirmative litigation and advocacy opportunities that advance Sanofis drug pricing and market access positions.

- Provide litigation strategy counsel across the Law Divisions drug pricing and government program docket, working alongside (not in place of) the attorneys managing individual matters, to ensure litigation positions are coordinated with Sanofis broader policy and advocacy strategy.

- Advise on the litigation risk and strategic implications of policy positions and program design choices before they are adopted.

*Internal Program Design & Defense:*

- Partner with market access legal, market access, and government pricing teams to help design internal programs (e.g., 340B integrity and credit programs, PBM-related initiatives) that are both commercially sound and legally defensible.

- Help build the legal and factual record needed to defend Sanofis programs in litigation, agency proceedings, and public/legislative debate.

*Advocacy & Third-Party Engagement:*

- Serve as Sanofis representative on key trade association working groups (e.g., PhRMA) addressing drug pricing reform, government pricing, and market access policy, representing Sanofis interests and coordinating positions with industry peers.

- Represent Sanofis legal perspective in other industry coalitions and forums on drug pricing reform, government pricing, and market access policy.

- Collaborate with Government Affairs, Public Policy, and Communications to develop and advance Sanofis legislative and regulatory positions, including engagement with Congress, HHS, CMS, HRSA, and relevant state agencies.

- Engage directly with government and regulatory agencies to represent Sanofis legal perspective and advocate for policy outcomes consistent with Sanofis strategy.

*Cross-Functional Partnership & Senior Leadership Counsel:*

- Serve as a trusted strategic advisor to senior Law Division and business leadership, preparing and presenting clear, actionable analysis on high-stakes drug pricing and policy questions.

- Serve as a primary point of contact ensuring legal, policy, and litigation strategies are integrated and coherent across functions rather than developed in silos.

- Prepare and deliver training to commercial, market access, and compliance teams on relevant legal requirements and strategic positioning.

**About You**

**Basic Qualifications**

- J.D. from an ABA-accredited law school; active bar membership in good standing in at least one U.S. jurisdiction.

- Minimum 8 years of experience as a practicing attorney, including substantial experience in complex litigation (through discovery, dispositive motions, and/or trial) and in developing and executing legal or policy strategy at a global company, government agency, trade association, or top law firm.

- Demonstrated ability to master complex, unfamiliar subject matter quickly and to exercise sound judgment before becoming a subject-matter expert.

- Demonstrated strategic thinking, creativity, and sound judgment a track record of shaping positions and strategy, not just executing on settled ones.

- Strong executive presence and communication skills, with the ability to advise and influence senior leaders and to represent the Law Division credibly with external stakeholders.

- Highly collaborative, with the interpersonal skill to build trust and alignment across legal, business, and policy functions.

*Preferred Qualifications:*

- Working knowledge of the 340B Drug Pricing Program and other federal government pricing programs (Medicaid Drug Rebate Program, Federal Supply Schedule, Medicare Part B/Part D), including familiarity with Best Price, AMP, and ceiling price concepts. Direct 340B experience (contract pharmacy, duplicate discounts, diversion, HRSA ADR proceedings) is a plus given this roles ongoing operational 340B responsibilities but is not required at hire.

- Experience with, or working knowledge of, PBM reform, Most Favored Nation (MFN) policy, Inflation Reduction Act (IRA) drug price negotiation, or related drug pricing reform issues.

- Experience litigating constitutional claims, statutory and regulatory challenges, and/or Administrative Procedure Act (APA) matters.

- Experience engaging with trade associations, government agencies, and/or state attorneys general on policy or litigation matters.

- A federal appellate clerkship or comparable litigation pedigree.

- Enthusiasm for using AI and emerging technology to work more effectively.

**Why Choose Us?**

- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave.
- Make your work count by supporting a company that brings life-changing treatments to millions and is committed to doing right by patients, communities, and the planet.
- Drive progress from within by helping simplify, scale, and modernize how a global biopharma business delivers smarter, faster, and more sustainably
- Support teams across science, medicine, and operations by building better systems, shaping bold strategies, and enabling innovation at speed

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

\#GD-SA

\#LI-SA

\#vhd

\#LI-Hybrid

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can [be found here.](<https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi>)

District of Columbia

Daiichi Sankyo

Associate Director, Regulatory Affairs Advertising and Promotion

Job Description

Job Title: Associate Director, Regulatory Affairs Advertising and Promotion

Job Requisition ID: 1826

Posting Start Date: 7/16/26

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

**Job Summary**

The Associate Director, Regulatory Affairs Advertising and Promotion (RAAP) provides strategic and tactical regulatory support for U.S. promotional and selected non-promotional communications across assigned products, disease-state initiatives, and related external-facing materials within the Daiichi Sankyo portfolio.

Reporting to the Head of RAAP, this role serves as a primary Regulatory reviewer and subject matter expert for assigned scope and helps ensure materials are developed, reviewed, and approved in accordance with FDA regulations, guidance, approved labeling, internal standards, and relevant regulatory precedent prior to dissemination.

The Associate Director provides practical, risk-based regulatory guidance to cross-functional stakeholders and supports compliant, business-aligned promotional execution. This role is responsible for independent day-to-day review of assigned materials, participation in cross-functional review forums, and contribution to review practices that improve consistency, efficiency, and transparency across the RAAP function.

The Associate Director applies established regulatory standards and precedent within assigned scope and escalates novel, high-risk, or precedent-setting matters to the Head of RAAP, as appropriate.

**Job Description**

**Responsibilities**

Promotional Review, Regulatory Intelligence, and Regulatory Assessment

- Provide regulatory review, guidance, risk assessment, and mitigation recommendations for branded and unbranded promotional materials to ensure compliance with FDA advertising and promotion requirements, approved labeling, internal policies, and company standards.
- Review a broad range of HCP- and patient-facing promotional materials and assess them for consistency with prescribing information, fair balance, risk communication, evidentiary support, and relevant FDA/OPDP expectations.
- Apply current laws, regulations, guidances, enforcement trends, and regulatory precedent to assigned reviews and recommend practical, compliant solutions that support business objectives.
- Maintain current knowledge of evolving advertising and promotion requirements and communicate relevant regulatory developments and implications to stakeholders and colleagues.

Strategic Regulatory Guidance and Cross-Functional Leadership

- Participate in concept-stage discussions and formal promotional review meetings to provide proactive, solution-oriented, and risk-based regulatory guidance during material development.
- Serve as the RAAP reviewer for assigned products and communications within PMRT and other cross-functional review forums.
- Partner with Medical, Legal, Compliance, Commercial, Clinical, Labeling, Public Affairs, Corporate Communications, Market Access, including alliance partners to support aligned, efficient, and compliant review of promotional materials.
- Build effective working relationships with stakeholders and escalate significant regulatory issues, interpretive questions, or unresolved cross-functional disagreements to RAAP leadership, as appropriate.

Governance, Policy Interpretation, and Health Authority Support

- Serve as a RAAP reviewer in promotional review committees and as a functional representative on the Labeling Working Team for assigned products and materials, as appropriate.
- Guide and support required promotional submissions, including Form FDA 2253, Subpart E/H, advisory comment submissions, and other regulatory filing activities.
- Support ad/promo interactions with OPDP and other regulatory authorities in partnership with RAAP leadership.
- Apply current FDA regulations, guidances, enforcement trends, compliance letters, and relevant regulatory precedent to assigned reviews, and escalate ambiguous, novel, or high-risk interpretive issues as appropriate.

Functional Support, Process Improvement, and Capability Building

- Support implementation and reinforcement of consistent RAAP review practices, workflows, decision principles, and review expectations across assigned products and materials.
- Assist in development, maintenance, and application of internal procedures, standards, guidance documents, and review tools related to promotional review.
- Support continuous improvement efforts that enhance review quality, consistency, transparency, and efficiency across the RAAP function.
- Provide training and knowledge-sharing for internal stakeholders on advertising and promotion requirements, enforcement trends, and company expectations.

**Qualifications**

**Education Qualifications**

- Bachelor's Degree Scientific, healthcare, or related discipline required
- PharmD, PhD, MS, MPH, or JD preferred

**Experience Qualifications**

- 7+ years relevant pharmaceutical or biotechnology industry experience in Regulatory Affairs, including direct support of U.S. advertising and promotion review preferred
- 4+ years U.S. regulatory affairs advertising and promotion review experience in oncology with product launch experience required

**Travel Requirements**

In-house office position that may require occasional travel.

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

**Salary Range:**

USD$166,720.00 - USD$250,080.00

[Download Our Benefits Summary PDF](<https://dmscdn.successfactors.com/886bee122c7aa5b9923a39bc71a2674d43c27f80448c122562765b1812b407af/static_content/1659df144cbb4da8ae09/2026_BenefitsHighlightsForPublicPosting.pdf>)

Professionals

Dyne Therapeutics

Senior Director, Business Strategy & Operations - Office of the CCO

**Company Overview:**

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as preclinical programs for facioscapulohumeral muscular dystrophy (FSHD), Pompe disease and multiple DMD mutations. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at [https://www.dyne-tx.com/](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DaBhdU0rLyxqDF5MLc_hIfw7usSG4P5AlGZUt689alyH6v7mzOmFdpd9s5X8DlnvZSiEkR5UEisX91xRDuQTa2VgG02ByJmFzR8fXOPz8Zi8%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825271389%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=J6tnBKJnocuFhoQSNnLD03mlmX8CCP4Ufz89Tz2BRqY%3D&reserved=0>), and follow us on [X](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DLBKooGRVe4UrE2Sa6ReueOswzx2nXn5X8MuiTcNNQ_6lX0cFP8Xf24jpFASx3QmF9Qt-1g3RGsigqX34LIiwMg%3D%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825316922%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=1SaJTlzgJLAz3INco8zVJpHByglVu9H3uR4eaUUwqbY%3D&reserved=0>), [LinkedIn](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DV9e03kLdDWSbh0_VwnuvS9iTb21RRXsSKiAaMEbducMXKsrR2S-Gw7FLuap5gHCzvcaUIvGPyAeg1wRzFGrqW9J_Z6Ha8bGtJaWV9voKp-c%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825339609%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=bDmOn9uD5vB9%2F2LttEyLg%2BANoH6v3vDFv7SAwVdi%2BoI%3D&reserved=0>) and [Facebook](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DCMyzCcuOkxGNqTNEki-upZwJJPBCJLp0a-MvjKwwfPo1XQp8XutL02Vy2Vg3ZmpnCYnPLhHxcgEzFeh-07gg_rWzXbiw64-AClVkXbKyKQs%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825359448%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=exQuTFG7FGBX1V0XPy4zSebLvhQUDksB19Nej8Eg3DQ%3D&reserved=0>).

**Role Summary:**

As Dyne advances toward commercialization, we are seeking a Senior *Director, Business Strategy & Operations – Office of the CCO* to work at the center of the Commercial organization and help shape how it sets priorities, makes decisions, and executes.

This role reports directly to the Chief Commercial Officer (CCO) and works in close daily partnership with the Commercial Leadership Team. Working directly with the CCO, this leader will serve as a trusted strategic thought partner and force multiplier to the CCO and Commercial Leadership Team. The role will help frame and resolve the most important strategic, organizational, and operational questions facing Commercial, lead high-priority initiatives, and ensure critical decisions translate into coordinated action.

This is a broad, highly visible role for a leader who combines strategic rigor with strong execution. The successful candidate will be comfortable tackling ambiguous problems, influencing senior stakeholders without formal authority, simplifying complexity, and moving fluidly between enterprise-level questions and hands-on delivery.

The role offers the opportunity to help build a Commercial organization at a pivotal stage in Dyne's evolution, with direct exposure to the CCO, Commercial Leadership Team, Executive Committee, and Board.

This is a full-time position based in Waltham, MA.

**Primary Responsibilities Include:**

*Strategic Partnership to the CCO:*

- Serve as a trusted strategic advisor to the CCO, helping identify, frame, and resolve the highest-priority issues facing the Commercial organization.

- Partner with the CCO and Commercial Leadership Team to assess priorities and trade-offs, prepare key decisions, and translate those decisions into clear action.

- Develop clear, decision-oriented insights and recommendations for the CCO and Commercial Leadership Team.

*Strategic & Enterprise Initiatives:*

- Lead high-priority strategic and cross-functional initiatives on behalf of the CCO, particularly where the stakes are high, ownership is unclear, or coordination spans multiple functions.

- Structure complex and ambiguous business problems, establish decision frameworks and workplans, and drive initiatives from problem definition through resolution and execution.

*Commercial Leadership & Operating Model:*

- Help shape and evolve the Commercial operating model as Dyne builds toward launch and future growth.

- Establish an effective leadership operating rhythm, including strategic planning, governance, business reviews, and decision-making processes.

*Executive & Organizational Effectiveness:*

- Develop Executive- and Board-level materials that distill complex issues into clear strategic narratives, choices, and recommendations.

- Help build a high-performing Commercial leadership culture characterized by clarity, collaboration, accountability, and effective decision-making.

- Support organizational planning and capability-building as the Commercial organization grows and evolves.

**Education and Skills Requirements:**

- 15+ years of experience, including demonstrated experience operating as a strategic advisor to C-suite executives.
- Bachelor’s degree required; advanced degree (MBA, PharmD, PhD) preferred.
- Strategy consulting background within life sciences preferred.
- Exceptional strategic problem-solving and analytical capabilities, with a demonstrated ability to structure ambiguous questions and translate insights into actionable recommendations.
- Proven ability to lead cross-functional initiatives and influence effectively without formal authority.
- Exceptional written and verbal communication skills, including the ability to simplify complexity for senior audiences.
- Strong judgment and the maturity to navigate complex, sensitive, and often confidential business issues.
- Commercial strategy, rare disease, or product launch experience.
- Experience supporting an organization through late-stage development, significant growth, organizational transformation, or commercialization.
- Strong prioritization, organizational awareness, and follow-through.
- Highly self-directed and comfortable operating in a dynamic environment with evolving priorities.

\#LI-Onsite

MA Pay Range

$233,000 - $280,000 USD

The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills.

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

*Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.*

Massachusetts

Thought Leader Liaison - Midwest

**Company Overview:**

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as preclinical programs for facioscapulohumeral muscular dystrophy (FSHD), Pompe disease and multiple DMD mutations. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at [https://www.dyne-tx.com/](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DaBhdU0rLyxqDF5MLc_hIfw7usSG4P5AlGZUt689alyH6v7mzOmFdpd9s5X8DlnvZSiEkR5UEisX91xRDuQTa2VgG02ByJmFzR8fXOPz8Zi8%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825271389%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=J6tnBKJnocuFhoQSNnLD03mlmX8CCP4Ufz89Tz2BRqY%3D&reserved=0>), and follow us on [X](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DLBKooGRVe4UrE2Sa6ReueOswzx2nXn5X8MuiTcNNQ_6lX0cFP8Xf24jpFASx3QmF9Qt-1g3RGsigqX34LIiwMg%3D%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825316922%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=1SaJTlzgJLAz3INco8zVJpHByglVu9H3uR4eaUUwqbY%3D&reserved=0>), [LinkedIn](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DV9e03kLdDWSbh0_VwnuvS9iTb21RRXsSKiAaMEbducMXKsrR2S-Gw7FLuap5gHCzvcaUIvGPyAeg1wRzFGrqW9J_Z6Ha8bGtJaWV9voKp-c%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825339609%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=bDmOn9uD5vB9%2F2LttEyLg%2BANoH6v3vDFv7SAwVdi%2BoI%3D&reserved=0>) and [Facebook](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DCMyzCcuOkxGNqTNEki-upZwJJPBCJLp0a-MvjKwwfPo1XQp8XutL02Vy2Vg3ZmpnCYnPLhHxcgEzFeh-07gg_rWzXbiw64-AClVkXbKyKQs%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825359448%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=exQuTFG7FGBX1V0XPy4zSebLvhQUDksB19Nej8Eg3DQ%3D&reserved=0>).

**Role Summary:**

The Director, Thought Leader Liaison develops and executes a strategic engagement model with external thought leaders in rare neuromuscular diseases to support Dyne’s commercial objectives. This role builds credible, compliant, and value-driven relationships with neuromuscular experts and advocates, translating insights into actionable commercial strategy. The role serves as a senior external-facing representative of Dyne, shaping disease-state understanding, treatment adoption, and long-term success of Dyne’s neuromuscular portfolio, and will be responsible for defined activities within the Midwest TLL region.

This is a field-based position. Candidates must reside within the assigned territory and within reasonable driving distance of a major commercial airport capable of supporting frequent regional and national travel.

**Primary Responsibilities include:**

*Thought Leader Strategy & Engagement*

- Develops and executes a comprehensive thought leader engagement strategy focused on rare neuromuscular diseases, aligned with Dyne’s commercial and portfolio priorities.
- Identifies, profiles, and prioritizes national and regional neuromuscular thought leaders based on expertise, influence, and strategic relevance.
- Builds and sustains long-term, trust-based relationships with clinicians and experts treating rare neuromuscular disorders through compliant, value-driven engagement.
- Serves as a credible commercial partner in discussions related to disease state education, evolving treatment paradigms, and unmet needs in neuromuscular disease.

*Insight Generation & Strategic Activation*

- Captures, synthesizes, and translates insights from neuromuscular thought leaders into actionable recommendations for brand, launch, and lifecycle strategy.
- Provides strategic input into positioning, messaging, and tactical planning that reflects the unique dynamics of rare disease diagnosis, treatment, and patient journeys.
- Monitors KOL insights related to current and future market dynamics and competitive intelligence through customer meetings, congresses, advisory boards, and analytics.
- Shares insights with commercial leadership and cross-functional partners to inform decision-making and optimize execution.

*Congress, Advisory Board & Peer-to-Peer Engagement*

- Leads commercial engagement strategy for key neuromuscular congresses, including pre-, during-, and post-meeting planning and follow-up.
- Designs and executes advisory boards, speaker programs, and peer-to-peer educational initiatives focused on rare neuromuscular disease education.
- Identifies and recruits appropriate KOLs for content development and other marketing projects, such as web content, training, handouts, and related materials.
- Partners cross-functionally to ensure consistency, effectiveness, and compliance across engagement forums.

*Cross-Functional Leadership & Governance*

- Collaborates and interfaces regularly across regions and with multiple departments, including Sales, Marketing, Medical Affairs, Market Access, Training, Legal, and Compliance, to ensure aligned and compliant execution.
- Manages vendor partnerships as needed, including medical education agencies, meeting services providers, and other external partners.
- Establishes metrics to assess effectiveness, impact, and ROI of thought leader engagement activities.
- Ensures all interactions adhere to regulatory, legal, and company compliance standards.

**Education and Skills Requirements:**

- Bachelor’s degree required; advanced degree preferred.
- 10+ years of experience in biotechnology or pharmaceutical commercial roles, with experience in rare disease or specialty markets strongly preferred.
- Demonstrated experience engaging neuromuscular or rare disease thought leaders in a commercial context.
- Strong understanding of the rare disease commercialization landscape, including diagnosis complexity, referral dynamics, and patient advocacy.
- Proven ability to translate complex scientific and clinical insights into clear, innovative, and actionable commercial strategies. Self-starter with the ability to deliver results in therapeutic areas with high unmet need.
- Excellent interpersonal, oral, and written communication skills, with strong execution focus and executive presence, and the ability to influence without authority.
- Strong cross-functional collaboration skills and experience operating in matrixed organizations.
- Demonstrated commitment to ethical, compliant engagement practices.
- Proven ability to manage a large geographical territory.
- Domestic travel up to 80% is required.

\#LI-Remote

MA Pay Range

$230,000 - $260,000 USD

The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills.

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

*Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.*

Thought Leader Liaison - Northeast

**Company Overview:**

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as preclinical programs for facioscapulohumeral muscular dystrophy (FSHD), Pompe disease and multiple DMD mutations. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at [https://www.dyne-tx.com/](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DaBhdU0rLyxqDF5MLc_hIfw7usSG4P5AlGZUt689alyH6v7mzOmFdpd9s5X8DlnvZSiEkR5UEisX91xRDuQTa2VgG02ByJmFzR8fXOPz8Zi8%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825271389%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=J6tnBKJnocuFhoQSNnLD03mlmX8CCP4Ufz89Tz2BRqY%3D&reserved=0>), and follow us on [X](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DLBKooGRVe4UrE2Sa6ReueOswzx2nXn5X8MuiTcNNQ_6lX0cFP8Xf24jpFASx3QmF9Qt-1g3RGsigqX34LIiwMg%3D%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825316922%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=1SaJTlzgJLAz3INco8zVJpHByglVu9H3uR4eaUUwqbY%3D&reserved=0>), [LinkedIn](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DV9e03kLdDWSbh0_VwnuvS9iTb21RRXsSKiAaMEbducMXKsrR2S-Gw7FLuap5gHCzvcaUIvGPyAeg1wRzFGrqW9J_Z6Ha8bGtJaWV9voKp-c%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825339609%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=bDmOn9uD5vB9%2F2LttEyLg%2BANoH6v3vDFv7SAwVdi%2BoI%3D&reserved=0>) and [Facebook](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DCMyzCcuOkxGNqTNEki-upZwJJPBCJLp0a-MvjKwwfPo1XQp8XutL02Vy2Vg3ZmpnCYnPLhHxcgEzFeh-07gg_rWzXbiw64-AClVkXbKyKQs%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825359448%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=exQuTFG7FGBX1V0XPy4zSebLvhQUDksB19Nej8Eg3DQ%3D&reserved=0>).

**Role Summary:**

The Director, Thought Leader Liaison develops and executes a strategic engagement model with external thought leaders in rare neuromuscular diseases to support Dyne’s commercial objectives. This role builds credible, compliant, and value-driven relationships with neuromuscular experts and advocates, translating insights into actionable commercial strategy. The role serves as a senior external-facing representative of Dyne, shaping disease-state understanding, treatment adoption, and long-term success of Dyne’s neuromuscular portfolio, and will be responsible for defined activities within the Northeast TLL region.

This is a field-based position. Candidates must reside within the assigned territory and within reasonable driving distance of a major commercial airport capable of supporting frequent regional and national travel.

**Primary Responsibilities include:**

*Thought Leader Strategy & Engagement*

- Develops and executes a comprehensive thought leader engagement strategy focused on rare neuromuscular diseases, aligned with Dyne’s commercial and portfolio priorities.
- Identifies, profiles, and prioritizes national and regional neuromuscular thought leaders based on expertise, influence, and strategic relevance.
- Builds and sustains long-term, trust-based relationships with clinicians and experts treating rare neuromuscular disorders through compliant, value-driven engagement.
- Serves as a credible commercial partner in discussions related to disease state education, evolving treatment paradigms, and unmet needs in neuromuscular disease.

*Insight Generation & Strategic Activation*

- Captures, synthesizes, and translates insights from neuromuscular thought leaders into actionable recommendations for brand, launch, and lifecycle strategy.
- Provides strategic input into positioning, messaging, and tactical planning that reflects the unique dynamics of rare disease diagnosis, treatment, and patient journeys.
- Monitors KOL insights related to current and future market dynamics and competitive intelligence through customer meetings, congresses, advisory boards, and analytics.
- Shares insights with commercial leadership and cross-functional partners to inform decision-making and optimize execution.

*Congress, Advisory Board & Peer-to-Peer Engagement*

- Leads commercial engagement strategy for key neuromuscular congresses, including pre-, during-, and post-meeting planning and follow-up.
- Designs and executes advisory boards, speaker programs, and peer-to-peer educational initiatives focused on rare neuromuscular disease education.
- Identifies and recruits appropriate KOLs for content development and other marketing projects, such as web content, training, handouts, and related materials.
- Partners cross-functionally to ensure consistency, effectiveness, and compliance across engagement forums.

*Cross-Functional Leadership & Governance*

- Collaborates and interfaces regularly across regions and with multiple departments, including Sales, Marketing, Medical Affairs, Market Access, Training, Legal, and Compliance, to ensure aligned and compliant execution.
- Manages vendor partnerships as needed, including medical education agencies, meeting services providers, and other external partners.
- Establishes metrics to assess effectiveness, impact, and ROI of thought leader engagement activities.
- Ensures all interactions adhere to regulatory, legal, and company compliance standards.

**Education and Skills Requirements:**

- Bachelor’s degree required; advanced degree preferred.
- 10+ years of experience in biotechnology or pharmaceutical commercial roles, with experience in rare disease or specialty markets strongly preferred.
- Demonstrated experience engaging neuromuscular or rare disease thought leaders in a commercial context.
- Strong understanding of the rare disease commercialization landscape, including diagnosis complexity, referral dynamics, and patient advocacy.
- Proven ability to translate complex scientific and clinical insights into clear, innovative, and actionable commercial strategies. Self-starter with the ability to deliver results in therapeutic areas with high unmet need.
- Excellent interpersonal, oral, and written communication skills, with strong execution focus and executive presence, and the ability to influence without authority.
- Strong cross-functional collaboration skills and experience operating in matrixed organizations.
- Demonstrated commitment to ethical, compliant engagement practices.
- Proven ability to manage a large geographical territory.
- Domestic travel up to 80% is required.

\#LI-Remote

MA Pay Range

$230,000 - $260,000 USD

The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills.

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

*Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.*

Associate Director, Formulation and Drug Product Development

**Company Overview:**

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as preclinical programs for facioscapulohumeral muscular dystrophy (FSHD), Pompe disease and multiple DMD mutations. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at [https://www.dyne-tx.com/](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DaBhdU0rLyxqDF5MLc_hIfw7usSG4P5AlGZUt689alyH6v7mzOmFdpd9s5X8DlnvZSiEkR5UEisX91xRDuQTa2VgG02ByJmFzR8fXOPz8Zi8%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825271389%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=J6tnBKJnocuFhoQSNnLD03mlmX8CCP4Ufz89Tz2BRqY%3D&reserved=0>), and follow us on [X](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DLBKooGRVe4UrE2Sa6ReueOswzx2nXn5X8MuiTcNNQ_6lX0cFP8Xf24jpFASx3QmF9Qt-1g3RGsigqX34LIiwMg%3D%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825316922%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=1SaJTlzgJLAz3INco8zVJpHByglVu9H3uR4eaUUwqbY%3D&reserved=0>), [LinkedIn](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DV9e03kLdDWSbh0_VwnuvS9iTb21RRXsSKiAaMEbducMXKsrR2S-Gw7FLuap5gHCzvcaUIvGPyAeg1wRzFGrqW9J_Z6Ha8bGtJaWV9voKp-c%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825339609%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=bDmOn9uD5vB9%2F2LttEyLg%2BANoH6v3vDFv7SAwVdi%2BoI%3D&reserved=0>) and [Facebook](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DCMyzCcuOkxGNqTNEki-upZwJJPBCJLp0a-MvjKwwfPo1XQp8XutL02Vy2Vg3ZmpnCYnPLhHxcgEzFeh-07gg_rWzXbiw64-AClVkXbKyKQs%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825359448%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=exQuTFG7FGBX1V0XPy4zSebLvhQUDksB19Nej8Eg3DQ%3D&reserved=0>).

**Role Summary:**

The Associate Director, Formulation and Drug Product Development will be accountable for all internal and external activities related to successful formulation development for Dyne’s bioconjugate drug products to ensure favorable manufacturability, product quality, and long-term stability. This role will partner closely with colleagues in Research, Pharmaceutical Quality, and Manufacturing to define Dyne’s strategy for bringing best-in-class medicines to patients in need, including high-concentration formulations for subcutaneous administration and lyophilized drug products to ensure seamless supply of all drug products for clinical trials.

This role is based in Waltham, MA without the possibility of being a remote role. Physical presence onsite is expected on 4-5 days/week.

**Primary Responsibilities Include:**

- Act as the subject matter expert for drug product development within the Technical Development group, including formulation development, selection of container closure systems, and sterile fill finish clinical manufacturing.
- Act as main point of contact for CDMO(s) for external formulation development activities, and liaise with the Research group to define, streamline and execute early-stage formulation development efforts.
- Build and enhance internal capabilities for formulation development in the laboratory.
- Responsible for development, tech transfer, and scale-up of drug product processes, and cGMP manufacturing of clinical grade drug product (Phase 1-3).
- Key contributor to drug product sections of early-stage clinical filings (INDs/IMPDs/Health Canada).
- Collaborate with Technical Development, Manufacturing, Quality Control, Quality Assurance, and Regulatory Affairs to ensure continuity of drug supply for early clinical evaluation.
- Responsible for driving execution of the formulation development plan at CDMO (PO through delivery).
- Champion a strong winning culture, fostering teamwork and commitment to excellence through transparent communication, engagement and collaboration.

**Education and Skills Requirements:**

- PhD or equivalent experience in a scientific discipline and a minimum of 8+ years related experience.
- Proven experience in clinical drug product formulation development including liquid fill finish, lyophilization, subcutaneous formulations, and other injectables.
- Expertise in sterile fill-finish early clinical manufacturing as well as understanding of analytical techniques that support manufacturing activities.
- Demonstrated understanding of the principles and applications associated with external manufacturing operations from development to clinical manufacturing.
- Strong experience and knowledge of cGMP manufacturing requirements.
- Strategic thinker with a sense of urgency to deliver quality results on time and in a highly ethical and professional manner.
- Experience managing complex schedules and priorities in a dynamic biotech environment.
- Ability to work, influence, and gain consensus across multiple functions (Technical Operations, Quality and Regulatory Affairs).
- Collaborative work style to be part of a team to identify process gaps and constructively develop solutions.
- Excellent interpersonal, verbal, and written communication skills with the ability to establish strong cross-functional relationships.
- Resilient and able to work in a demanding, fast-paced environment and capable of supporting multiple programs and vendors.

\#LI-Onsite

MA Pay Range

$159,000 - $195,000 USD

The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills.

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

*Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.*

BioMarin Pharmaceutical Inc.

Associate Director, Legal, Corporate Counsel, Product and Commercial

Who We Are

BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.

Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.

Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.

About Corporate Groups

It takes a village, and at BioMarin, our general and admin teams are the village behind our success. From the IT experts who manage our technology to the human resources professionals who hire the people who make it all possible, these teams support our organization and span all areas of operations.

**Associate Director, Corporate Counsel, Product and Commercial**

**Role and Responsibilities**

- Counsel internal stakeholders regarding advertising and promotion, external communications, sales and marketing initiatives, FDA and OIG guidance, and industry codes (e.g. PhRMA) as they relate to business activities and communications with healthcare professionals, payors, patients, and/or patient advocacy organizations.
- Serve as Legal reviewer across MLR committees for assigned products and disease states
- Independently draft, review, and negotiate commercial contracts to support BioMarin’s Commercial organization.
- Provide analysis, guidance, training, and support to functions such as Marketing, Sales, Market Access, Patient Advocacy, Medical Affairs, and Corporate Communications engaged in external communications and outreach related to pipeline and/or approved products and related conditions.
- Advise internal stakeholders on potential legal issues and appropriate risk mitigation strategies regarding advertising, promotion, product liability, anti-trust, and relevant healthcare rules and regulations (e.g., fraud and abuse, anti-kickback, and false claims act statutes).
- Work closely with Global Compliance & Ethics Program including counseling and training on compliance policies and healthcare compliance regulations.
- Assist with periodic compliance risk assessments and investigations of alleged violations of corporate policies and procedures, laws, or regulations, and advise on development and implementation of corrective action plans where compliance violations have been established.
- Prepare regular briefing documents to keep Executive Management up to date on latest industry events and trends related to key risk areas including OIG and FDA enforcement, CIA trends, and analysis of OPDP warning and untitled letters.
- Maintain current understanding of laws and regulations applicable to pharmaceutical/biotechnology companies, along with recent industry trends and changes.

**Education**

A JD degree and active bar license

**Experience**

- 3 - 7 years of experience working in a law firm or the pharmaceutical/healthcare legal/compliance field. Experience in-house, at a regulatory agency, or at a major law firm also welcome.
- Experience with pipeline and marketed brand support and associated statutes, regulations, guidance documents, enforcement trends, and best practices related to the pharmaceutical, biotechnology, and/or healthcare industry generally.
- Experience with AdPromo framework and as reviewer on MLR
- Experience in drafting, reviewing, and negotiating commercial agreements.
- Experience with the requirements for effective compliance programs as set forth in OIG Guidance and the Federal Sentencing Guidelines.
- Experience with the legal/compliance framework affecting the pharmaceutical/biotechnology industry; including, but not limited to, sales and marketing fraud and abuse issues, OIG and other industry guidance documents, clinical trial regulations, and issues arising under the Anti-Kickback Statute and the False Claims Act.
- Demonstrated effectiveness operating in complex organizational and regulatory environments.
- Excellent written, oral, and presentation skills.
- Proven ability to work with all levels of management and the general workforce, a strong sense of professionalism, and the drive to provide superb and timely support to internal clients.
- Strong problem solving, risk analysis, and project management skills.
- Demonstrated ability to partner effectively with others in addressing complex issues.
- Strong persuasive skills and sound business judgment.
- Motivated, self-starter with ability to appropriately prioritize issues, drive projects, and allocate resources.

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

California

Director, Data Product & Analytics Engineering – Pathway AI

Who We Are

BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.

Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.

Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.

About Digital, Technology & AI and Patient FIND

This role sits within BioMarin’s Digital, Technology & AI organization and supports the enterprise Patient FIND capability, a strategic, technology enabled effort to identify, reach, convert, and optimize patients across the full patient journey, from early signal detection through diagnosis, treatment initiation, retention, and line progression across BioMarin’s rare disease portfolio.

The Patient FIND capability connects Commercial, Medical Affairs, R&D, DTA, and external partners so that patient level intelligence can move from raw signal to governed data asset to clinical and commercial action.

BioMarin’s Patient FIND work is focused on the systematic use of structured data, including claims, EMR, lab, Rx, specialty pharmacy, CRM, digital engagement, and other relevant sources, combined with analytics and AI/ML to identify undiagnosed or undertreated patients at population scale. Priority approaches include claims and EMR mining, AI/ML patient identification, specialty pharmacy data, population segmentation, signal-based targeting, and digital intent signals.

Role Summary

The Director, Data Product & Analytics Engineering – Patient FIND Capability will be accountable for developing, owning, and delivering the reusable data product and analytics engineering foundation that enables BioMarin’s enterprise Patient FIND strategy to scale across brands, disease areas, geographies, and use cases.

This role serves as a senior technical operator and strategic execution leader at the intersection of data strategy, analytics engineering, data science enablement, governance, and business activation. The person in this role will translate Patient FIND strategy into governed, reusable, technically sound data products, analytical workflows, feature logic, quality controls, lineage, and measurement infrastructure that can support AI/ML models, CRM and field activation, BI, omnichannel workflows, and executive decision-making. This is a hands-on leadership role with direct accountability for moving Patient FIND from fragmented, use-case-specific builds toward a scalable enterprise capability. The role will define technical patterns, establish reusable data product standards, drive alignment across engineering, analytics, governance, commercial, medical, and external partner teams, and ensure early Patient FIND use cases create durable assets that can be reused and extended.

The ideal candidate brings direct experience with healthcare or life sciences data, strong SQL and Python capability, familiarity with claims, EHR/EMR, CRM, specialty pharmacy, digital engagement, or real-world data, and the ability to translate complex analytical work into technical requirements that enable business-ready decisions.

The role does not own enterprise Patient FIND strategy, commercial activation strategy, or formal governance decision rights; however, it will be accountable for translating those strategies and decisions into an executable data and analytics foundation, surfacing tradeoffs, recommending scalable paths forward, and ensuring the technical work is delivered with quality, reuse, governance, and measurable business impact.

Key Responsibilities

Patient FIND Data Translation and Technical Requirements

- Develop, own, and be accountable for the technical requirements framework for Patient FIND, translating business, scientific, and strategic priorities into executable data products, analytical logic, data flows, and measurable outcomes.
- Own and maintain an integrated view of Patient FIND use cases, source data, shared data layers, technical dependencies, implementation risks, and delivery priorities.
- Identify gaps in signals, data quality, processes, and technical approaches, and recommend scalable solutions that improve reuse, governance, and business impact.
- Lead technical translation and alignment across business, scientific, engineering, analytics, AI/ML, governance, and activation teams to convert ambiguity into executable plans.

Analytics Engineering and Reusable Data Products

- Develop, own, and deliver governed Patient FIND data products and analytical datasets across claims, EHR/EMR, lab, Rx, CRM, specialty pharmacy, digital engagement, and other approved data sources.
- Establish the reusable data product foundation and standards for feature logic, cohort definitions, metadata, lineage, quality controls, and analytical documentation.
- Ensure Patient FIND use cases build upon reusable assets and enterprise design patterns rather than creating one-off solutions.
- Define and execute a sequenced technical roadmap that prioritizes foundational capabilities, accelerates implementation, and supports long-term scale.

Data Science and Advanced Analytics Enablement

- Define and deliver the analytical data foundation required for patient identification, segmentation, HCP prioritization, predictive modeling, treatment progression, adherence, retention, and other Patient FIND use cases.
- Guide AI/ML teams on feature engineering, model input design, validation, monitoring, and scalable model-enablement practices.
- Provide technical leadership on tradeoffs involving model performance, governance, data quality, explainability, and downstream activation.

Signal Readiness, Governance Enablement and Data Quality

- Own the signal readiness framework for Patient FIND data assets and platform flows, ensuring required signals can be captured, linked, governed, and activated.
- Define and implement quality, governance, metadata, lineage, access, and consumption standards embedded within Patient FIND data products and workflows.
- Lead resolution of cross-functional data, platform, privacy, compliance, governance, and access issues, proactively surfacing risks and recommendations.

Deployment, Consumption and Measurement

- Define and own the deployment and measurement framework for Patient FIND outputs across CRM, field, marketing, BI, medical, omnichannel, and leadership workflows.
- Own the measurement data layer that connects patient identification, engagement, outcomes, and model refinement into a closed-loop learning capability.
- Ensure outputs are consumable, measurable, scalable, and actionable while providing leadership visibility into capability maturity, constraints, and investment opportunities.

Cross-Functional Technical Leadership

- Serve as the senior technical operating lead for the Patient FIND data product and analytics engineering capability.
- Drive alignment on technical priorities, shared definitions, quality expectations, governance requirements, and implementation approaches across Patient FIND stakeholders.
- Influence senior stakeholders and technical teams by translating complex technical and analytical tradeoffs into clear options, recommendations, and decision implications.
- Represent data product, analytics engineering, and technical readiness in roadmap, governance, investment, prioritization, and operating model discussions.

Capability Building and Future People Leadership

- Help define the future operating model, organizational structure, and capability roadmap required to scale Patient FIND across the enterprise.
- Serve as a player-coach, mentoring technical contributors and establishing standards, review practices, documentation, and delivery disciplines that raise capability maturity.
- Support future hiring, talent development, and succession planning for data product, analytics engineering, and AI/ML capabilities.

Required Qualifications

- Bachelor’s degree in Data Science, Computer Science, Engineering, Statistics, Mathematics, Bioinformatics, Health Informatics, Epidemiology, Life Sciences, or related quantitative field.
- 8+ years of progressive experience in data science, analytics engineering, healthcare analytics, data product development, life sciences analytics, or related technical leadership roles.
- Demonstrated experience leading complex, cross-functional data or analytics initiatives from ambiguous business need through technical design, delivery, governance, and downstream adoption.
- Strong SQL and Python capability, with experience transforming, profiling, validating, and analyzing large-scale healthcare or life sciences data.
- Experience developing reusable analytical datasets, feature logic, model inputs, data products, measurement layers, and production-grade analytical workflows.
- Experience working with healthcare or pharmaceutical data sources such as claims, EHR/EMR, lab data, Rx data, CRM, specialty pharmacy, hub/patient services, digital engagement, or real-world data.
- Demonstrated ability to set technical direction, influence senior stakeholders, and align matrixed teams around reusable data and analytics patterns.
- Strong understanding of data quality, metadata, reproducibility, lineage, access controls, privacy considerations, governed analytics, and AI/ML enablement.
- Proven ability to translate ambiguous strategic questions into structured technical requirements, build plans, tradeoffs, and recommendations.
- Strong executive communication skills, including the ability to explain data logic, technical risks, delivery options, and business implications to technical and non-technical audiences.
- Experience mentoring, guiding, or providing technical direction to data scientists, analytics engineers, contractors, or matrixed technical contributors.

Preferred Qualifications

- Experience in pharma, biotech, rare disease, specialty pharmacy, commercial analytics, medical analytics, RWD, HEOR, or patient identification and patient finding.
- Experience with Databricks, Snowflake, Azure, AWS, Dataiku, dbt, Airflow, Git, Power BI, Tableau, or similar modern data and analytics platforms.
- Familiarity with MLOps, model monitoring, CI/CD, API based data products, or production grade analytics workflows.
- Experience supporting commercial pharma use cases such as HCP targeting, patient finding, patient journey analytics, adherence, treatment switching, territory or account prioritization, launch analytics, or field effectiveness.
- Experience working in a highly regulated environment with privacy, compliance, legal, medical, and governance stakeholders.
- Familiarity with rare disease commercialization, diagnostic odyssey, claims or EHR signal detection, HCP network mapping, or patient activation pathways.
- Ability to work across technical teams and business teams, especially where ownership, definitions, and decision rights are still being clarified.

Key Capabilities

- Strategic Technical Ownership: Develops and owns the technical approach that turns enterprise strategy into reusable, governed, scalable data and analytics capability.
- Senior Operator Mindset: Moves ambiguous priorities into executable plans, clear accountabilities, quality standards, and measurable delivery.
- Connective Technical Leadership: Keeps business strategy, data engineering, data science, BI, governance, platform, and activation teams connected through one coherent technical design.
- Applied Data Strategy: Understands that value comes not only from building data assets, but from making them reusable, governed, measurable, explainable, and decision-ready.
- Data Product Leadership: Establishes reusable data product patterns, technical standards, documentation expectations, and consumption pathways that can scale across brands and use cases.
- Hands-On Technical Credibility: Builds, validates, documents, and improves analytical datasets, feature logic, model inputs, quality checks, lineage, and reusable workflows.
- Healthcare Data Fluency: Understands the strengths, limitations, linkage considerations, and appropriate use of patient-level and HCP-level healthcare data sources.
- Analytical Rigor: Brings disciplined thinking to cohorts, definitions, features, quality checks, validation, performance measurement, and continuous improvement.
- Business Translation and Executive Communication: Converts complex data and technical work into clear options, tradeoffs, recommendations, and decision implications.
- Governed Innovation: Moves quickly while embedding privacy, compliance, access, explainability, metadata, and responsible AI expectations into the work.
- Enterprise Mindset: Designs for repeatability, reuse, and scalability across brands, geographies, disease areas, and future Patient FIND use cases.
- Talent and Capability Building: Mentors technical contributors, establishes standards and playbooks, supports future hiring and onboarding, and helps build the foundation for a high-performing Patient FIND data and analytics team.

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Jazz Pharmaceuticals, Inc.

Senior Manager, Market Access & Patient Support Services- Tech Lead

**If you are a current Jazz employee please apply via the Internal Career site.**

Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit [www.jazzpharmaceuticals.com](<https://www.jazzpharmaceuticals.com>) for more information.

**Brief Description:**

At Jazz, we are reimagining how we design and deliver more precise customer experiences, enabled by new technologies, modern ways of working, and high performing team behaviors. Through this work, we enable teams to better understand patients, caregivers, and HCPs, anticipate their needs across the enterprise, deliver timely and personalized engagement, and orchestrate seamless, end-to-end experiences as One Jazz.

To power this ambition with both speed and scale, we are embracing a new product-oriented operating model, allowing business and technology teams to partner side by side in building, advancing, and delivering global capabilities across our enterprise. Cross-functional, empowered Global Capability teams own outcomes—not just outputs—and work from clear capability visions, strategies, and measurable goals. We prioritize user problems, validate solutions through experimentation and data, and iterate quickly to create real value for our users and the business. As part of this model, you’ll collaborate closely with users, stakeholders, and technical teams across the organization, using discovery and delivery practices to ensure we’re building the right things, in the right way, at the right time

The Tech Lead, Market Access & Patient Support Services, provides hands-on technical leadership and solution design expertise for the Market Access & Patient Support Services Global Capability team. Reporting to the Technical Suite Lead, this role serves capability priorities and global standards.as the primary technical leader for the capability, partnering closely with the Global Capability Owner, Activation Lead, development teams, and/or vendor teams to ensure

This role owns the delivery of the Patient Services Platforms. This role is a hands-on contributor and technical leader, directly involved in designing, building, and delivering solutions for alongside the development team, bringing technical depth and leadership to every stage of the work.

**Essential Functions/Responsibilities**

**Key Responsibilities:**

**Strategy, & Technical Roadmap Development**

- Partner closely with the Market Access & Patient Support Services Global Capability Owner to design solutions that solve business problems, providing technical insight on what the technology can and cannot do, effort levels, and tradeoffs.
- Collaborate with the Technical Suite Lead and Architects to translate capability roadmaps into scalable technology architectures and development plans while assessing feasibility, constraints, dependencies, and risks.
- Convert complex business requirements into clear technical specifications and executable technical work tasks.

**Solution Architecture & Technical Delivery**

- Lead the technical team and drive work plans, building, configuration, and integration of software aligned to business needs and technology standards, including:

- Deep hands-on experience with Salesforce declarative customization:
- Custom Objects, Validation Rules, OWD Settings, Profiles, Roles, Approval Processes, Permission Sets, Flows, Process Builders, etc.
- Proficiency with:
  - **Salesforce Shield**
  - **Service Cloud and Experience Cloud**
  - Apex classes, triggers, trigger frameworks, batch processing, and email services
  - Lightning Web Components (LWC) or Aura
  - Declarative tools (Flow Builder, Process Builder)
  - External client application configuration and best practices
- Integration and development experience with **REST APIs, Platform Events, Change Data Capture, Streaming APIs**.
- Familiarity with development tools such as **Salesforce DX, Git, GitHub, VS Code, and CI/CD pipelines**.
- Understanding of **SAML and IDP** concepts.

- Translate technical requirements into well-defined work for the development team, lead agile ceremonies, and ensure disciplined execution of the capability roadmap, taking ownership of complex technical challenges end to end.
- Guide development teams in building scalable, secure, and compliant solutions aligned to enterprise architecture standards.
- Ensure consistent implementation of standards, templates, and workflows across the market access and patient support service platforms.
- Support integration of tools with data platforms, analytics, and downstream execution platforms to enable continuous optimization.
- This lead will work closely with the data and REMS leads to ensure appropriate integrations.

**Solution Architecture & Technical Delivery**

- Partner with business, IT security, and vendor teams to ensure the Market Access and Patient Support Service team's technical solutions adhere to organizational standards, security policies, and regulatory requirements.
- Organize and direct vendor partners to execute technical work, ensuring alignment with capability priorities, delivery timelines, and enterprise standards.
- Partner with the Technical Suite Lead, Market Access & Patient Support Services, to escalate and resolve complex technical challenges that span across Global Capability teams.
- Mentor and guide software engineers and developers, elevating the team's overall technical capability.
- Lead cross-team problem solving and resolution of technical challenges within the Global Capability team.

**Required Knowledge, Skills, and Abilities**

**Technical Skills**

- Experience designing, testing, deploying, operating, and enhancing scalable, secure, and compliant technology solutions for large-scale organizational use.
- Understanding of enterprise software architecture, cloud platforms, and modern engineering frameworks. Knowledge of system integration patterns, APIs, and data architecture across enterprise technology platforms.
- Strong understanding of Patient Service Support Platforms and Patient CRM concepts
- Understanding of security, compliance, and regulatory requirements relevant to patient data, patient services, hub integrations and REMS processes
- Demonstrates strong hands-on technical delivery capabilities, effectively translating business requirements into technical specifications and guiding development teams and vendor partners to deliver high-quality solutions.
- Experience working within Agile product development teams and product operating models.

**Business Skills**

- **Strategic Storytelling -** ability to craft purposeful, compelling narratives that make sense of change, inspire action, and align people around a shared direction
- **Cross functional Matrix Collaboration -**  ability to work fluidly across teams and reporting lines respecting SME, coordinating shared work, ensuring progress even when accountability is distributed – supporting decisions with professional alignment and focus on collective success.
- **Customer Journey Understanding -**  ability to see customer’s end-to-end experience clearly, anticipate needs across touchpoints, and make practical decisions that improve journey and outcomes.
- **Outside In Thinking -** ability to view problems, opportunities and decisions from customer, market or external stakeholder perspective and leverage external best practice to better shape solutions and strategy
- **Critical Thinking** - ability to assess a range of inputs objectively, challenge assumptions with curiosity, and generate sound, forward‑looking judgments that improve decisions.
- **Business Acumen -**  ability to understand how value is truly created – financially, operationally, for customers and to use this insight to make decisions that drive meaningful business outcomes
- **Contracting and Managing Trade-Off** - ability to negotiate clear agreements on scope and deliverables with the ability to make decisions when resources, priorities and outcomes compete -weigh options, impacts and risks across

**Required/Preferred Education and Licenses**

**Qualifications:**

- Bachelor's degree in computer science, engineering, information systems, or related technical field.
- 7+ years of experience in software engineering, technical architecture, or enterprise platform development; or 7+ years of experience after Bachelor's degree (or 4-6+ years after Master's degree) in \[relevant domain — e.g., field force effectiveness, CRM platforms, content management, campaign operations\].
- 2+ years of experience as a Tech Lead, or similar role involving hands-on technical leadership of a development team.
- Demonstrated experience designing and delivering enterprise-scale digital platforms such as \[Platform examples relevant to the capability\].
- Experience working within complex, matrixed organizations with multiple technology and product teams.
- Proven ability to mentor and guide developers and vendor partners to deliver high-quality solutions.

**Preferred / Additional Qualifications:**

- Experience in pharmaceutical or healthcare industries preferred.

- Experience partnering with enterprise platform teams or Global Capability teams supporting digital and operational capabilities.
- Experience working in rare disease or specialty brands, with strong understanding of unique stakeholder dynamics.

**Working Requirements:**

- 10-20% travel will be required.

**Jazz Expected Behaviors**

- **Demonstrates ownership and accountability**, taking responsibility for outcomes and driving work forward with urgency, clarity, and a focus on impact.
- **Leads with curiosity and a Growth Mindset**, actively exploring user needs, emerging technologies, and new ways of working to elevate capability and innovation.
- **Embraces change as a learning opportunity**, adapting quickly, modeling resilience, and helping others navigate dynamic environments.
- **Acts with a One Jazz mindset**, prioritizing enterprise value, breaking down silos, and building strong, trust-based partnerships across teams.
- **Delivers high performance results**, setting ambitious goals, challenging assumptions, and consistently driving measurable business impact.
- **Models inclusive, collaborative leadership**, creating space for diverse perspectives and empowering others to contribute their best work.
- **Invest in continuous learning**, developing personal skills while coaching and elevating the capabilities of colleagues and cross functional partners.
- **Navigates ambiguity with confidence**, using sound judgment, data, and user insights to make informed decisions even when information is incomplete.
- **Communicates with clarity and influence**, simplifying complexity, aligning stakeholders, and ensuring shared understanding of priorities and outcomes.

\#LI-SP1

\#LI-Remote

*Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.*

**FOR US BASED CANDIDATES ONLY**

Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $141,600.00 - $212,400.00

Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis.

At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.

The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: [https://careers.jazzpharma.com/benefits.html](<https://careers.jazzpharma.com/benefits.html>).

Pennsylvania

IDEAYA Biosciences

Vice President, Investor Relations & Corporate Communications

**Non-Solicitation Policy and Notice to Agencies and Recruiters:**

**IDEAYA's Non-Solicitation Policy strictly prohibits agencies and recruiters from any contact and communication with IDEAYA employees, managers, and leaders to submit unsolicited candidate resumes and/or to solicit business partnerships**. Submission of unsolicited candidate resumes by agencies or recruiters with or without a contract in place with IDEAYA Biosciences Inc. will not create any implied obligation. Failure to comply with this policy will result in disqualification from current and future business opportunities with IDEAYA Biosciences. All recruiting and talent agency decisions are strictly managed by the internal IDEAYA Human Resources function. All communication by external agencies and recruiters must be directed to humanresources@ideayabio.com. We ask that you only email your interest once.

Job Summary

About IDEAYA Biosciences:

IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer.

When you're at IDEAYA, you will be in the midst of brilliant minds working on precision medicine therapies to help cancer patients. We are passionate and committed about being on the forefront of oncology medicine, which means we all have a high internal drive that is at the very core of every person at IDEAYA. We are inquisitive, ask deep questions, and are data-driven innovators who like to collaborate and use team work to move science forward. For more information, please see www.ideayabio.com.

Location: South San Francisco, CA.

Position Summary:

IDEAYA is seeking a Vice President, Investor Relations & Corporate Communications to join the team. The Vice President, Investor Relations & Corporate Communications will establish and lead an integrated Investor Relations and Corporate Communications organization during a pivotal stage in IDEAYA's growth towards becoming a commercial stage company. Reporting to the Chief Financial Officer and serving as a trusted advisor to the Chief Executive Officer and Executive Leadership Team, this individual will have responsibility for establishing IDEAYA’s IR and corporate communications strategy, capabilities and infrastructure to ensure consistency of messaging with key objectives and purpose while strengthening its reputation with internal and external stakeholders and the broader biotechnology community.

This is a foundational leadership opportunity for an executive who enjoys building organizations. Initially, the Vice President will be a hands-on leader responsible for both strategy and execution—shaping the Company's external narrative, leading investor engagement, designing internal and external corporate communications, preparing executive messaging, and supporting key corporate milestones. As IDEAYA grows, this leader will recruit and develop other high-performing individuals to help establish the infrastructure, processes, and capabilities necessary to support a leading commercial biotechnology company.

This is an onsite leadership position based at IDEAYA's headquarters in South San Francisco and required to be onsite four days per week per company policy. The role requires close collaboration with executive leadership and cross-functional teams, making regular in-person engagement essential to success.

Reporting to: Chief Financial Officer

Job Description

**What you’ll do:**

**Investor Relations**

- Develop and execute a comprehensive investor relations strategy aligned with IDEAYA's corporate objectives and long-term value creation strategy.
- Serve as a key point of contact for institutional investors, sell-side analysts, prospective shareholders, and the investment community.
- Partner closely with the CEO and CFO to prepare for quarterly earnings, investor conferences, non-deal roadshows, and individual investor meetings.
- Lead the development of earnings materials, press releases, investor presentations, executive talking points, Q&A documents, and messaging surrounding corporate earnings, clinical data presentations, regulatory milestones, strategic partnerships, financing activities, and other material corporate events.
- Monitor shareholder composition, analyst models, peer performance, and investor sentiment, providing strategic insights to executive leadership and the Board of Directors.
- Ensure compliance with SEC disclosure requirements, Regulation FD, and public company governance standards.

**Corporate Communications**

- Develop and execute a comprehensive corporate communications and reputation strategy that strengthens IDEAYA's reputation, credibility, and visibility across key internal and external stakeholders.
- Develop and steward IDEAYA's enterprise narrative, aligning the Company's scientific innovation, clinical progress, business strategy, and commercial evolution into a compelling corporate story.
- Anticipate and lead integrated communications strategies around major corporate milestones and strategic events that shape IDEAYA's reputation and long-term growth.
- Oversee the development of press releases, executive communications, website content, annual reports, ESG messaging, digital communications, and other external communications materials.
- Develop executive thought leadership opportunities and prepare senior leadership for media, investor, and public engagements.
- Identify and proactively plan for emerging reputational opportunities and risks; drive crisis communications planning and advise executive leadership on actions that strengthen trust and protect IDEAYA's reputation.
- Partner with the Human Resources, and functional leaders to develop an enterprise internal communications strategy that strengthens employee understanding of corporate strategy, major milestones, organizational priorities, culture, and the Company’s evolution.

**Build and Scale the Function**

- Build IDEAYA's Investor Relations and Corporate Communications function from the ground up, including organizational design, operating processes, governance, systems, and communications infrastructure.
- Develop a multi-year strategy to scale the function in support of the Company's continued growth and commercialization objectives.
- Recruit, develop, mentor, and lead a high-performing Investor Relations and Corporate Communications team as organizational needs evolve.
- Evaluate and manage external agencies, investor targeting firms, communications consultants, and other strategic partners while thoughtfully transitioning appropriate capabilities in-house over time.
- Partner closely with Commercial, Clinical Development, Medical Affairs, Regulatory Affairs, Business Development, Legal, Finance, and Human Resources to ensure coordinated, consistent, and impactful communications across the organization.

**Executive Leadership**

- Serve as a trusted strategic advisor to the CEO, CFO, Executive Leadership Team, and Board of Directors on communications strategy, investor engagement, reputation management, and external stakeholder communications.
- Establish and lead enterprise communications governance to ensure consistent messaging, clear accountability, and effective cross-functional coordination.
- Foster a culture of transparency, collaboration, and excellence in all external communications.

**Requirements:**

- Bachelor's degree in Finance, Business, Communications, Life Sciences, or a related field; MBA or advanced scientific degree preferred.
- 15+ years of progressive leadership experience in investor relations, corporate communications, equity research, media or related roles within the biotechnology or pharmaceutical industry.
- Significant experience supporting publicly traded biotechnology companies.
- Strong understanding of biotechnology drug development, clinical development, regulatory pathways, and capital markets.
- Demonstrated success building trusted relationships with institutional investors, research analysts, media outlets, patient advocacy groups, executive leadership teams, and Boards of Directors.
- Exceptional written, verbal, and presentation skills with the ability to communicate complex scientific and financial information clearly and effectively.
- Experience leading communications around clinical, regulatory, financing, and strategic corporate milestones.
- Proven ability to operate effectively in a fast-paced, high-growth environment.
- Experience building or significantly expanding an Investor Relations and/or Corporate Communications organization.
- Experience supporting a company's evolution from clinical-stage to commercial-stage operations.
- Oncology or precision medicine experience.
- Experience supporting capital markets transactions.
- Established relationships within the biotechnology investment community and industry media.
- Experience supporting one or more commercial product launches.

**Leadership Competencies**

- Strategic thinker with exceptional business judgment and financial acumen.
- Entrepreneurial builder who enjoys creating organizations, developing talent, and establishing scalable processes.
- Collaborative leader who builds strong partnerships across scientific, clinical, financial, operational, and commercial functions.
- Outstanding organizational and project management skills with exceptional attention to detail.
- High integrity, sound judgment, and commitment to confidentiality.
- Calm and effective under pressure, particularly during periods of heightened market activity and significant corporate events.
- Ability to balance strategic leadership with hands-on execution in a dynamic, growth-oriented environment.

All employees are expected to act with integrity and in full compliance with applicable laws, regulations, and IDEAYA policies, including IDEAYA’s Code of Conduct.

Employees must demonstrate good judgement and ethical behavior in all business activities, maintain patient and product safety as a top priority, and report any suspected violations of law or Company policy through appropriate channels

**Total Rewards**

Along with our inspiring mission, and highly collaborative and inclusive environment, IDEAYA offers a competitive total rewards package that reflects our pay-for-performance philosophy where employees are eligible to be considered for merit-based salary increases, company discretionary short-term incentive plan participation, and company discretionary stock option awards (based on board approval). Our comprehensive benefits package includes, but is not limited to, medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents), 401k, ESPP, and wellness programs.

The expected salary range for the roleof Vice President, Investor Relations & Corporate Communications is $309,000 - $381,000. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the office location where this open position is located, the final candidates’ experience within their profession, experience in the disease areas we are striving to make an impact in as a company, length of time within the industry, educational background, and performance during the interview process.

The Company complies with all laws respecting equal employment opportunities and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law.

IDEAYA is an equal opportunity employer. In accordance with applicable law, IDEAYA does not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status. EOE/AA/Vets.

We are committed to providing reasonable accommodations to qualified individuals with disabilities. If you need assistance or an accommodation due to a disability, please get in touch with us at hr@ideayabio.com.

Alumis Inc.

Senior Director, Medical Strategy and Operations

Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients.

This role will serve as a strategic and operational partner to the Vice President of Medical Affairs and Medical leadership team, and is responsible for ensuring that medical capabilities, processes, systems, and execution models are efficient, compliant, scalable, and aligned with Alumis’ growth strategy. The Senior Director, Medical Strategy and Operations, will be responsible for advancing key initiatives aimed at optimizing and showcasing the impact of the Medical Affairs team. This is a hands-on position that includes driving medical strategic initiatives, enhancing the Medical Affairs systems, supporting critical medical insights processes, and developing innovative solutions to measure and report on medical affairs performance and impact. The role demands an individual who combines scientific knowledge with strong operational leadership to thrive in a fast-paced, agile environment to elevate our medical affairs capabilities.

**Key Responsibilities:**

**Strategic Leadership:**

- Lead and drive the development and execution of initiatives that elevate the strategic and operational effectiveness of the Medical Affairs team in a consistent and scalable manner.

**Medical Affairs Systems Optimization:**

- Oversee the design, implementation, and optimization of our Medical Affairs systems to improve internal efficiencies, engagement and communications with key opinion leaders (KOLs), healthcare providers, and other relevant stakeholders.
- Lead continuous improvement initiatives to enhance efficiency, quality, and compliance across the Medical function.
- Implement best practices for operational metrics, KPIs, dashboards, and reporting to support data-driven decision-making.

**Medical Insights:**

- Collaborate with Medical Affairs Leadership to collect, analyze, and integrate valuable medical insights that inform strategic decisions and optimize the impact of our medical programs.

**Content Management:**

- Serve as Medical Affairs content owner through review and approval process for external-facing materials.

**Cross-functional Collaboration**

- Collaborate with other functional areas such as Clinical Development, Marketing, Market Access, Commercial, Analytics, Compliance, and Regulatory to ensure alignment and integration of medical excellence within the broader organizational strategy.

**Guidance and SOP Development:**

- Leverage expertise to develop guidance documents and SOPs to foster consistency, clarity, and accountability across Medical Affairs.

**Planning, Budgeting & Resource Management**

- Lead medical annual planning, forecasting, and budget management.
- Optimize headcount planning, vendor strategy, and external spend to maximize impact and efficiency.
- Provide transparency and insights into medical investments and their impact.

**Qualifications:**

- **Experience**: Minimum of 10 years in Medical Affairs leadership. Proven experience in managing and optimizing medical operations, systems, content, and medical insights. Experience in a fast-paced, small biotech environment a plus
- **Education**: Advanced degree (PhD, MD, MBA, PharmD or similar)
- **Leadership Skills**: Exceptional leadership abilities with a demonstrated ability to manage cross-functional teams and drive change across complex medical operations. Must have track record of effectively leading without authority
- **Operational Expertise**: Strong experience in developing and managing Medical Affairs dashboards and other qualitative outcomes to measure impact and performance.
- **Strategic Thinking**: Ability to develop and implement strategic initiatives aligned cross-functionally that drive organizational goals and enhance the impact of Medical Affairs functions.
- **Strong Communication**: Excellent communication and interpersonal skills, with the ability to engage and influence stakeholders at all levels, both internally and externally.

The salary range for this position is $265,00 USD to 310,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company’s compensation practices degree and background.

Alumis compensation packages include generous stock option grants for all employees as well as an annual bonus program.

Other benefits include:

- Health insurance premiums paid at 90% for employee, 80% for dependents
- Free access to Genentech Bus & Ferry Share program
- $100 monthly cell phone stipend
- Unlimited PTO for Exempt employees
- Free onsite gym and a kitchen stocked with yummy snacks and drinks!

We are a hard-working, collaborative team on a mission to transform patient’s lives-- and we aspire to **elevate**, **challenge** and **nurture** one another along the way.

**Alumis Inc. is an equal opportunity employer.**

Tris Pharma

Manager, Medical Communication

Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned US biopharmaceutical company focused on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. We have \>150 US and International patents and market several branded ADHD products in the US. We also license our products in the US and ex-US markets. Our robust pipeline of innovative products employing our proprietary science and technology spans neuroscience and other therapeutic categories.

Our science and technology make us unique, but our team members set us apart; they’re the engine fueling Tris’ passion and innovation. Our colleagues understand the criticality of operating a successful business and take pride in the company’s success. Equally important is how we interact on a daily basis. We believe in each other and in respectful, open and honest communication to help support individual and team success.

We have an immediate opening in our Monmouth Junction, NJ facility for an experienced Manger, Medical Communication.

The Manager, Medical Communications supports the Medical Affairs department by providing in-depth scientific knowledge and expertise to the planning, development and maintenance of scientific medical content and projects and the timely dissemination of current, accurate and balanced product information. Collaborating closely with internal key Research and Development (R&D) and Commercial departments and external vendors/partners the incumbent uses their knowledge and expertise to serve as a therapeutic area and product expert for both internal and external customers.

Primary duties/responsibilities

- Identifies and executes scientific educational opportunities to reach targeted partners, ensuring all initiatives are impactful and aligned with overarching medical strategy

- Directs development, quality control and internal endorsement of core scientific assets including, but not limited to: Scientific Communication Platforms, Lexicons, Disease-State Education materials, Congress resources, etc.

- Leads creation and tactical delivery of medical content for major scientific congresses, serving as a primary point of contact for congress-related Medical Affairs activities

- Manages end-to-end process for medical review committees, taking accountability for successful approval and strategic alignment of all materials

- Serves as a Subject Matter Expert (SME) to ensure medical integrity, scientific accuracy and fair/balanced representation of all Medical Communication assets

- Leads and oversees vendor interactions and agency partners, providing rigorous oversight of scientific quality, project timelines and deliverable milestones; Collaborates with Project Management to monitor budget allocation and track systematic spend, ensuring all projects are delivered with fiscal responsibility and high return on investment (ROI)

- Designs and maintains centralized resource repositories (e.g., SharePoint) to ensure internal teams have streamlined access to the most current scientific/medical materials

Requirements

REQUIRED QUALIFICATIONS

- Advanced degree in medical/biosciences (i.e., MD, DO, PharmD, PhD, etc.) and minimum 3 years Medical Communications or related experience in pharmaceutical, biotechnology or related industry REQUIRED
- Strong broad-based scientific and pharmaceutical knowledge REQUIRED
- Knowledge of pharmaceutical compliance laws, regulations and guidelines related to scientific communications, as well as industry best practices related to Medical Communication activities REQUIRED
- Working knowledge of Commercial Operations functions and strategies REQUIRED
- Experience in medical writing and understanding of publication requirements and journal submissions REQUIRED
- Ability to understand and effectively evaluate and communicate scientific and medical information to both internal and external customers REQUIRED
- Ability to travel by car and air up to 25% (occasionally on weekends) REQUIRED
- Experience in Central Nervous System (CNS)/Psychiatry, ADHD or Pain therapeutic area PLUS

Work Arrangements: We are a HYBRID work environment requiring local candidates to be able to work majority of week in our NJ office.

Anticipated salary range: $125-145K/yr. Base salary offered is contingent on assessment of candidate’s education and experience level relative to requirements of the position and a review of related industry standards and internal equity.

Additional Benefits: In addition to base salary, full-time employees are also eligible for incentives, including but not limited to: bonus eligible, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid Company Holidays, PTO, Paid Volunteer Time, and Employee Resource Groups.

Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer. #LI-hybrid

Associate Director, Strategic Forecasting and Portfolio Analytics

**Position Summary:**

Reporting to the Director of Strategic Forecasting & STF CoE, you will lead forecasting programs centered around decision analytics for the CSL Hematology portfolio.

This position will lead forecasting projects in the Hematology therapy area, and will be responsible for following:

- Direct point of contact for forecasting needs for commercial development and Brand/Marketing leads for pipeline and Inline (LCMs) assets
- Specialist for assumptions and inputs for short term forecast and budget planning
- Subject matter expert for the end-to-end execution of long-range planning for Hematology
- This position will manage projects and initiatives supporting Short term forecasting Center of Excellence
- This position is critical for investigating and answering key business questions globally, influencing R&D and clinical programs, guiding asset strategy, and contributing to go-no-go decisions of various development programs across CSL
- You will be a trusted partner, both within the Global Forecasting & Portfolio Analytics team and across the organization

**Main Responsibilities & Accountabilities:**

- Lead the development and management of comprehensive long-term forecasting models for global therapeutic areas, ensuring accuracy and alignment with business objectives.
- Collaborate closely with Hematology therapeutic area leaders within commercial development organization as well as PST/GPLs within R&D, and commercial & corporate finance teams to integrate forecasting insights into the annual long-range planning workstream and other strategic initiatives
- Collaborate with International and US I&A teams on developing thorough understanding of commercial inputs and assumptions for short term forecast and Budget planning.
- Present forecast scenarios and recommendations to senior leadership and key stakeholders, ensuring alignment with organizational goals and market expectations
- Provide strategic guidance on market trends, competitive landscapes, and emerging therapeutic opportunities to inform global forecasting and business strategies
- Oversee sales data analysis, market research, and external benchmarks to develop robust and reliable forecasts
- Collaborate and support other functions within the Forecasting COE - particularly BD&L, three-year forecasting, and Portfolio/Decision Analytics
- Lead the execution of long range-plan which entails coordinating with the short-term forecast team/regions to along on the 3-year forecast; Developing 4-to-10-year volume forecast (baseline & events); Alignment with Global & Regional and pricing teams through review meetings/workshops; Overseeing scenario modeling; forecast submission
- Stay updated on industry trends, regulatory changes, and advancements in forecasting methodologies within the biotech and pharmaceutical sectors
- Mentor and manage a team of forecasters (including contractors and offshore resources) responsible for planning, managing and delivering long-term strategic volume and revenue forecasting projects, both , fostering a culture of innovation, accuracy, and continuous improvement

**Qualifications & Experience Requirements:**

- Minimum of a Bachelor’s Degree with preferred focus in a scientific or business field (decision sciences, finance, analytics, economics, analytics/statistics or related). Post-graduate qualifications preferred.
- 8-10 years’ experience in the pharmaceutical/biotechnology industry working across multiple therapeutic areas; plus at least 5+ years or experience running/leading forecasting/analytics teams in biotech/pharma industry
- Strong analytical and problem-solving skills, with the ability to translate complex data into actionable insights.
- Excellent communication and stakeholder management skills, with the ability to influence without authority and collaborate effectively across functions and levels of the organization.
- Strength in storytelling, data visualization, and developing effective presentations including use of Think-Cell tool
- Ability to prioritize and manage multiple priorities in a lean organization; Experience working in multi-site/global environment
- Experienced with multiple forecasting & BI tools including Flexicast, Forecast Pro, Decision Suite/@Risk or any monte carlo simulation tools, Tableau, QlikSense etc.
- Experience working with Rx, patient claims, pricing (WAC) and managed markets data sources (e.g. IQVIA, SHS, MMIT, Komodo, Clarivate, IPD Analytics)
- Experience with multiple epi, sales, and syndicated datasets such as Clarivate, Evaluate Pharma, Globaldata, IQVIA, Symphony, ADIVO, GERS, UNOS, Oracle EpiDB, Datamonitor, etc.
- Fluent in ability to embed AI into recurring workflows to improve efficiency and turnaround time
- Entrepreneurial attitude and approach; Positive attitude and strong collaboration skills
- Understanding of Machine learning approaches and AI solutions /applications within forecasting

The expected base salary range for this position at hiring is $199,000 - $236,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position in Waltham, MA as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.

Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.

**About CSL Behring**

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit [https://www.csl.com/](<https://www.csl.com/>) and CSL Plasma at [https://www.cslplasma.com/](<https://www.cslplasma.com/>).

**Our Benefits**

For more information on CSL benefits visit [How CSL Supports Your Well-being | CSL](<https://www.cslbenefits.com/csl/candidates>).

**You Belong at CSL**

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

**Equal Opportunity Employer**

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit [https://www.csl.com/accessibility-statement](<https://www.csl.com/accessibility-statement>).

Insmed Incorporated

Field Access Manager - Baton Rouge, LA

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as *Science* magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on *The Sunday Times* Best Places to Work list in the UK.

For patients, for each other, and for the future of science, we’re in. Are you?

**About the Role:**

We’re looking for a Field Access Manager on the Patient Services team to help us expand what’s possible for patients with serious diseases. Reporting to the Director, Field Access Managers you will have a unique opportunity to support patient access to prescribed treatment and deliver upon an industry leading patient experience for patients battling serious and rare diseases.

In this role you will cover Baton Rouge, LA and Jackson, Mississippi areas.

**What You'll Do:**

In this role, you’ll have the opportunity to establish collaborative relationships with Patient Support Services, Field Sales, Channel Management, and Market Access colleagues to support patient access.

You’ll also:

**Who You Are:**

You have a Bachelor’s Degree along with 5+ years’ hands-on experience in reimbursement and patient access, market access, specialty pharmacy, or physician/system account management.

You are or you also have:

• Experience navigating payer reimbursement process, preferably Medicare Part D (pharmacy benefit design and coverage policy)

• Experience with specialty products acquired through specialty pharmacy networks and experience working with HCP offices

• Proven record of success through cross functional collaboration and execution

• Patient-centric and service-oriented mindset, with a high degree of emotional intelligence and empathy

• Exemplary interpersonal and listening skills

• Strong communication (written and verbal), and presentation skills

• Understanding of patient privacy laws including HIPAA and similar state laws

• High enthusiasm with a drive to success within a team – demonstrated ability to reach common goals in collaboration with multiple therapeutic specialists, sales leadership, market access, and patient support services colleagues

• Highly organized with a strong attention to detail

• Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook)

**Nice to have (but not required):**

• Product launch experience preferred

**Where You’ll Work**

This is a field role. It can be performed effectively from anywhere while staying connected to your Insmed team and community.

**Travel Requirements**

This position involves frequent Domestic travel (up to 75%).

\#LI-TB1

\#LI-Remote

**Pay Range:**

$155,000.00-201,500.00 Annual

**Life at Insmed**

At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.

Highlights of our U.S. offerings include:

- Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
- Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
- 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
- Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
- Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.

**_Current Insmed Employees: Please apply via the Jobs Hub in Workday._**

*Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. For more information, please refer to our* [*Equal Employment Opportunity and Non-Discrimination Statement*](<https://insmed.com/documents/EEO-and-Non-Discrimination-Statement-of-Policy.pdf>) *on our Careers site.*

*It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.*

*Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.*

*Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at* [*TotalRewards@insmed.com*](<mailto:TotalRewards@insmed.com>) *and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.*

*Applications are accepted for 5 calendar days from the date posted or until the position is filled.*

Nurix Therapeutics

Director, Regulatory Affairs (Strategy, I&I)

**Director, Regulatory Affairs - Strategy, Autoimmune Disease (AID)**

*Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.*

Nurix Therapeutics, Inc. is seeking a Director, Regulatory Affairs (Strategy, AID) to join the Regulatory team. The successful candidate will be a core member of the Regulatory team and will serve as the global regulatory lead (GRL) for the immunology and inflation therapeutic area. This role will be responsible for developing the global regulatory strategy in collaboration with key internal stakeholders, as well as tactical implementation of that strategy guiding and executing compliant, high quality, nonclinical and clinical submissions and interactions in support of early development, registration and life cycle management activities. This position works cross-functionally with regulatory affairs and clinical development organizations to facilitate the completion of regulatory filing documentation according to company timelines. It also ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as required. This position is on site in the Brisbane, CA office.

**Responsibilities:**

- Develop and implement competitive and effective global clinical & nonclinical regulatory strategies for various immunology and inflammation indications and identify potential risks and mitigation strategies associated with proposed strategies
- Work in close collaboration with the SVP, Head of Regulatory Affairs and the development team leader and other cross-functional colleagues, including CROs to deliver sound, efficient development strategies and operational plans
- Represent Regulatory Affairs on assigned cross-functional development teams.
- Lead and manage the development and preparation of high-quality global submissions (including IND, CTAs, NDAs, and MAAs) for early and late-stage programs in collaboration with the regulatory and project teams to support and accelerate clinical development and regulatory approval, as applicable
- Lead communication with global Health Authorities (HA), such as FDA and EMA, including, planning and preparing for formal meetings with regulatory agencies and interpreting HA feedback from these interactions.
- Develops and executes, or oversees global regulatory strategy for long-term planning, including the potential to accommodate expedited development needs
- Anticipate issues and guide cross-functional teams on risk mitigation strategies for any development challenges Provides insight and guidance on the implementation of current regulations and assesses regulatory risk based on precedence
- Ensure adherence to current regulations associated with regulatory activities
- Works strategically with all regulatory functions to develop detailed, actionable submission plans, tracks major submission deliverables, and ensures consistent management submission documents, health authority communications, and all other regulatory information supporting Nurix’s investigational and marketing applications
- Plays an essential part in defining requirements for, implementing, and supporting future systems and tools to be employed by Nurix in the areas of document management, submission content planning, and regulatory information management
- Tracks the status of major deliverables for regulatory submissions (e.g., study reports, summary documents, labeling) along with their dependencies
- Develops and maintains submission plan templates to ensure Nurix regulatory submissions are consistently planned and executed across programs
- Participates in cross-functional process initiatives impacting regulatory submission processes and systems
- Manages consultants and contractors as needed

**Requirements:**

- Bachelor's degree in life-sciences or related scientific discipline; advanced degree preferred
- Must have minimum of 12 years in Regulatory affairs strategy with significant experience in the immunology and inflammation therapeutic area
- Strong demonstration of knowledge of drug development, FDA, EMA and ICH guidelines and regulations
- Experience providing hands-on support for planning clinical trial and marketing applications to health authorities including but not limited to FDA, EMA
- Proven track record of supporting Regulatory affairs in the planning and execution of major filings and ongoing maintenance of clinical trial and marketing applications
- Strong project management and critical thinking skills
- Experience applying project management techniques and tools (e.g., MS Project, Smartsheet, Excel trackers) to the planning and execution of regulatory submissions
- Excellent organizational and communication skills, both written and verbal
- Ability to work independently as well as part of a team environment
- Positive attitude, energetic and proactive
- Proven ability to manage multiple projects, identify and resolve regulatory issues
- Strong interpersonal skills and the ability to effectively work with others

**Salary Range:**  $220,000 – $254,000

**Location:**  Onsite Brisbane, California

**Fit with Nurix Culture and Values**

- Strong team orientation; highly collaborative
- Solutions and results-oriented focus
- Hands-on approach; resourceful and open to diverse points of view

Field Access Manager, Denver Colorado

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as *Science* magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on *The Sunday Times* Best Places to Work list in the UK.

For patients, for each other, and for the future of science, we’re in. Are you?

**About the Role:**

We’re looking for a Field Access Manager on the Patient Services team to help us expand what’s possible for patients with serious diseases. Reporting to the Director, Field Access Managers you will have a unique opportunity to support patient access to prescribed treatment and deliver upon an industry leading patient experience for patients battling serious and rare diseases.

In this role you will cover: Denver, Colorado

**What You'll Do:**

In this role, you’ll have the opportunity to establish collaborative relationships with Patient Support Services, Field Sales, Channel Management, and Market Access colleagues to support patient access.

You’ll also:

• Assist in resolution of patient-specific access barriers to Insmed’s products as prescribed by HCP

**Who You Are:**

You have a Bachelor’s Degree along with 5+ years’ hands-on experience in reimbursement and patient access, market access, specialty pharmacy, or physician/system account management.

You are or you also have:

• Experience navigating payer reimbursement process, preferably Medicare Part D (pharmacy benefit design and coverage policy)

• Experience with specialty products acquired through specialty pharmacy networks and experience working with HCP offices

• Proven record of success through cross functional collaboration and execution

• Patient-centric and service-oriented mindset, with a high degree of emotional intelligence and empathy

• Exemplary interpersonal and listening skills

• Strong communication (written and verbal), and presentation skills

• Understanding of patient privacy laws including HIPAA and similar state laws

• High enthusiasm with a drive to success within a team – demonstrated ability to reach common goals in collaboration with multiple therapeutic specialists, sales leadership, market access, and patient support services colleagues

• Highly organized with a strong attention to detail

• Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook)

**Nice to have (but not required):**

• Product launch experience preferred

**Where You’ll Work**

This is a field role. It can be performed effectively from anywhere while staying connected to your Insmed team and community.

**Travel Requirements**

This position involves frequent Domestic travel (up to 75%).

\#LI-JT1

\#LI-Remote

\#LI-Field

**Pay Range:**

$155,000.00-201,500.00 Annual

**Life at Insmed**

At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.

Highlights of our U.S. offerings include:

- Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
- Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
- 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
- Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
- Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.

**_Current Insmed Employees: Please apply via the Jobs Hub in Workday._**

*Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. For more information, please refer to our* [*Equal Employment Opportunity and Non-Discrimination Statement*](<https://insmed.com/documents/EEO-and-Non-Discrimination-Statement-of-Policy.pdf>) *on our Careers site.*

*It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.*

*Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.*

*Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at* [*TotalRewards@insmed.com*](<mailto:TotalRewards@insmed.com>) *and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.*

*Applications are accepted for 5 calendar days from the date posted or until the position is filled.*

Director / Sr. Director, Regulatory Affairs (Strategy, Oncology Solid Tumors)

**Job Summary:**

*Nurix Therapeutics, Inc. is seeking a Director/ Sr. Director, Regulatory Affairs (Strategy, Oncology – Solid Tumors) to join the Regulatory team. The successful candidate will be a core member of the Regulatory team working in close collaboration with the SVP, Head of Regulatory Affairs and other cross-functional colleagues. This role will be responsible for developing and executing the global regulatory strategy in collaboration with key internal stakeholders, as well as tactical implementation of that strategy, guiding and executing compliant, high quality, nonclinical and clinical submissions and interactions in support of registration and life cycle management activities. This position works cross-functionally with regulatory affairs and clinical development organizations to facilitate the completion of regulatory filing documentation according to company timelines. It also ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as required.*

**Responsibilities:**

- Develop a comprehensive regulatory strategy that takes into account worldwide regulatory requirements to drive product development, global registration, achievement and maintenance of desired regional labeling, and effective regulatory agency interactions
- Identify potential risks and mitigation strategies associated with proposed strategies
- Represent Regulatory Affairs on assigned cross-functional development teams.
- Lead and manage the development and preparation of high-quality global submissions (including IND, CTAs, NDAs, and MAAs) for early and late-stage programs in collaboration with the regulatory and project teams to support and accelerate clinical development and regulatory approval, as applicable
- Support communication with global Health Authorities (HA), such as FDA and EMA, including, planning and preparing for formal meetings with regulatory agencies and interpreting HA feedback from these interactions.
- Develops and executes, or oversees global regulatory strategy for long-term planning, including the potential to accommodate expedited development needs
- Anticipate issues and guide cross-functional teams on risk mitigation strategies for any development challenges Provides insight and guidance on the implementation of current regulations and assesses regulatory risk based on precedence
- Ensure adherence to current regulations associated with regulatory activities
- Works strategically with all regulatory functions to develop detailed, actionable submission plans, tracks major submission deliverables, and ensures consistent management submission documents, health authority communications, and all other regulatory information supporting Nurix’s investigational and marketing applications
- Plays an essential part in defining requirements for, implementing, and supporting future systems and tools to be employed by Nurix in the areas of document management, submission content planning, and regulatory information management
- Tracks the status of major deliverables for regulatory submissions (e.g., study reports, summary documents, labeling) along with their dependencies
- Develops and maintains submission plan templates to ensure Nurix regulatory submissions are consistently planned and executed across programs
- Participates in cross-functional process initiatives impacting regulatory submission processes and systems
- Manage consultants and contractors as needed

**Experience and Skills:**

- Bachelor's degree in life-sciences or related scientific discipline; advanced degree preferred
- Must have minimum of 12 years in Regulatory affairs strategy with significant experience in the oncology (solid tumors) therapeutic area
- Strong demonstration of knowledge of drug development, FDA, EMA and ICH guidelines and regulations
- Experience providing hands-on support for planning clinical trial and marketing applications to health authorities including but not limited to FDA, EMA
- Proven track record of supporting Regulatory affairs in the planning and execution of major filings and ongoing maintenance of clinical trial and marketing applications
- Strong project management and critical thinking skills
- Experience applying project management techniques and tools (e.g., Veeva RIM, Smartsheet, Excel trackers, etc) to the planning and execution of regulatory submissions
- Excellent organizational and communication skills, both written and verbal
- Ability to work independently as well as part of a team environment
- Positive attitude, energetic and proactive
- Proven ability to manage multiple projects, identify and resolve regulatory issues
- Strong interpersonal skills and the ability to effectively work with others

**Nurix Culture and Values**

- Strong team orientation; highly collaborative
- Solutions and results-oriented focus
- Hands-on approach; resourceful and open to diverse points of view

**Salary Range:** Director: $232K - $274K

Senior Director: $279K - $331K

**Location:** Brisbane, CA (Onsite role)