Regulatory

BioMarin Pharmaceutical Inc.

Senior Director, Commercial Legal Affairs

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.

Senior Director, Commercial Legal Affairs

**Job Summary**

The Senior Director, Commercial Legal Affairs serves as a strategic legal partner to BioMarin's U.S. Commercial organization, providing practical, risk-based legal counsel across the full spectrum of commercial activities within a highly regulated environment. This role supports commercial functions including Marketing, Market Access, Pricing, Patient Services, Medical Affairs, Advocacy, Commercial Operations, Business Insights, and related functions.

The successful candidate will advise on a broad range of legal, regulatory, and compliance matters, including promotional and advertising activities, FDA regulatory requirements, product commercialization, market access and reimbursement, payer contracting, antitrust, product liability, patient support programs, healthcare fraud and abuse laws, False Claims Act risk, advocacy engagement, privacy considerations, and business development initiatives. This individual will collaborate closely with business leaders and cross-functional partners to advance BioMarin's strategic objectives while protecting the company's integrity, reputation, and commitment to patients.

**Key Responsibilities**

**Strategic Commercial Counseling**

- Serve as the lead legal advisor for U.S. Commercial functions, providing practical, business-oriented legal counsel that enables strategic decision-making while appropriately managing legal and reputational risk.
- Partner with commercial leadership to develop and implement business strategies consistent with applicable legal, regulatory, and compliance requirements.
- Advise on product launches, lifecycle management, commercialization strategies, market development initiatives, and portfolio planning.

**Advertising, Promotion, and Medical Legal Review**

- Work with cross-functional colleagues to optimize the Medical, Legal, and Regulatory (MLR) review process, ensuring that responsibilities are appropriately allocated among stakeholders and that the process is scalable across products and geographies.
- Provide legal advice regarding prescription drug advertising and promotion, including compliance with FDA requirements, guidance, enforcement trends, and industry standards.
- Participate in Medical, Legal, and Regulatory (MLR) review processes.
- Review and counsel on:
- Promotional materials and campaigns
- Product claims and comparative claims
- Digital and social media communications
- Speaker programs and educational initiatives
- Scientific exchange activities
- Health economic and outcomes information
- Disease awareness and unbranded communications
- External communications regarding clinical and scientific data

**Market Access, Pricing, and Contracting**

- Provide legal counsel on market access and reimbursement strategies.
- Advise on:
- Government pricing requirements and reporting obligations
- Medicaid, Medicare, 340B, Veterans Health Care Act, and related programs
- State and federal pricing transparency requirements
- Market access promotional considerations
- HEOR and value communications
- Support the development, negotiation, interpretation, and administration of customer contracts involving:
- Commercial and government payers
- Pharmacy Benefit Managers (PBMs)
- Group Purchasing Organizations (GPOs)
- Specialty pharmacies and specialty distributors
- Wholesalers and distribution partners
- Integrated Delivery Networks (IDNs)
- Healthcare providers and health systems
- Patient services vendors
- Review and negotiate rebate agreements, value-based arrangements, administrative service agreements, distribution agreements, data agreements, and other commercial contracting arrangements.

**Healthcare Compliance and Fraud & Abuse**

- Advise on compliance with federal and state healthcare laws and regulations, including:
- Federal Anti-Kickback Statute
- False Claims Act
- Government pricing and reimbursement requirements
- OIG guidance and advisory opinions
- State healthcare compliance requirements
- PhRMA Code
- Support internal investigations, risk assessments, audits, and compliance initiatives as needed.

**Patient Support Programs and Advocacy**

- Counsel business partners on the design, operation, and compliance of patient support and patient assistance programs.
- Advise on interactions and collaborations with patient advocacy organizations and related stakeholders.
- Provide guidance regarding grants, sponsorships, educational support, and patient engagement activities.

**Antitrust, Competition, and Product Liability**

- Advise on antitrust and competition law issues arising from commercial strategy, contracting, pricing, market access activities, and interactions with competitors, customers, and trade associations.
- Partner with internal stakeholders and outside counsel on product liability matters, litigation-related risk assessments, and response strategies.
- Support legal oversight of commercial practices and commercial policies to mitigate litigation and enforcement risks.

**Cross-Functional Collaboration and Leadership**

- Collaborate closely with Compliance, Regulatory, Medical Affairs, Corporate Affairs, Government Affairs, and other Legal colleagues to deliver coordinated legal support.
- Manage external counsel effectively and responsibly.
- Stay informed regarding evolving legal, regulatory, and enforcement developments affecting the biopharmaceutical industry.
- Contribute to Legal & Compliance Department initiatives, team development, training, and knowledge-sharing efforts.
- Serve as a trusted advisor to senior leadership and provide leadership within the Legal & Compliance organization.

**Qualifications, Professional Skills, and Preferred Experience**

- JD from an ABA-accredited law school.
- Active membership in at least one state bar.
- Minimum of 12 years of post-JD legal experience, including significant experience in the biopharmaceutical, pharmaceutical, biotechnology, medical device, or life sciences industry, either in-house, at a law firm, or both.
- Significant experience supporting commercial pharmaceutical operations and product commercialization.
- Demonstrated expertise advising on:
- FDA advertising and promotion requirements
- Commercial and brand strategy
- Healthcare fraud and abuse laws
- False Claims Act considerations
- Market access and reimbursement
- Government pricing
- Patient support and assistance programs
- Antitrust and competition law
- Commercial contracting
- Product liability and risk management
- Deep understanding of laws, regulations, and guidance applicable to commercial pharmaceutical activities, including FDA regulations, Medicare, Medicaid, 340B, Anti-Kickback Statute, False Claims Act, state healthcare laws, pricing transparency laws, OIG guidance, and PhRMA Code requirements.
- Significant experience reviewing, drafting, negotiating, and counseling on a broad range of commercial agreements, including payer, distribution, patient services, data, and services arrangements.
- Strong judgment and ability to provide practical, business-focused legal advice in a dynamic and highly regulated environment.
- Outstanding written and verbal communication skills, with the ability to effectively communicate complex legal concepts to both legal and non-legal audiences.
- Excellent analytical, strategic thinking, problem-solving, and organizational skills.
- Ability to manage multiple high-priority matters while maintaining exceptional quality and responsiveness.
- Demonstrated success influencing senior leaders and operating effectively in a matrixed organization.
- Strong people leadership, collaboration, and stakeholder management skills.
- Experience supporting specialty medicines and rare disease products is highly desirable.
- Demonstrated commitment to integrity, ethics, patient focus, and BioMarin's values.
- Thrives in a fast-paced, collaborative, and evolving environment and is eager to take on new challenges.

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

Associate Director, Health Economics & Outcomes Research (HEOR)

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 Commercial

Be part of the worldwide infrastructure that gets our drugs to underserved patients around the world. Our global sales force solidifies BioMarin’s commercial presence in the United States and Europe and is rapidly growing in other regions, such as South America, EuMEA, and Asia-Pacific.

Summary

The Health Economics & Outcomes Research (HEOR) Associate Director supports asset-specific payer evidence strategies, including patient-relevant outcomes strategy, to generate differentiated evidence, strengthen the payer value proposition, and optimize access for BioMarin assets across a specific therapeutic area of interest. This role contributes to shaping patient-relevant outcomes requirements within the clinical programs, helping ensure alignment with Regulatory, HTA and access needs. In partnership with internal cross-functional and external stakeholders, the Associate Director supports the design and execution of patient-relevant outcomes research initiatives.

The Associate Director builds effective working relationships with cross-functional partners across Value & Access, Commercial, Medical Affairs, Clinical Development, Regulatory Affairs and Patient Advocacy, while supporting engagement with external stakeholders including HTA agencies, payers and patient organizations. This role requires solid expertise in patient-relevant outcomes research and a strong understanding of market access, value and HTA frameworks.

The position reports to the Senior Director, HEOR within the Global HEOR team which sits within the Pricing Access Value & Evidence (PAVE) organization.

Description

• Lead the development, execution and communication of payer evidence strategies aligned with brand and Value & Access priorities for early-stage pipeline assets

• Collaborate closely with Value & Access, Commercial, Medical Affairs, Clinical Development & Regulatory Affairs & Patient Advocacy organizations

• Contribute to organizational understanding of payer and HTA requirements related to patient-relevant outcomes and health utility measurement

• Support the strategic assessment of patient-relevant outcomes requirements for HTA and access to support differentiation and value demonstration

• Ensure payer evidence requirements are incorporated into clinical development plans to enable optimal patient access

• Lead the development of cross-functionally aligned, asset-specific patient-relevant outcomes strategies informed by disease conceptual models

• Support patient-relevant endpoint planning and assist with implementation within clinical trials

• Lead early Joint Clinical Assessment (JCA) strategy development, including assessment of access implications and trade-offs across markets

• Assess payer evidence gaps and inform future integrated evidence planning for early-stage pipeline assets

• Manage and partner with external partners in the execution of asset-level patient-relevant outcomes strategies, including PRO development and validation, health state valuation studies (time trade-off or standard gamble), and patient preference research, as appropriate

• Support scientific interactions with HTA agencies, particularly scientific advice (e.g., EU HTA JSC, NICE, CADTH), including preparation of briefing materials and evidence packages related to PRO endpoints, MCIDs, etc

• Support scientific interactions with regulatory agencies and patient advocacy organizations

• In partnership with the Integrated Evidence Teams (IET), lead the exploration, analysis and interpretation of patient-relevant outcomes data from clinical trials to generate insights, and strengthen value propositions for HTA, payer and other stakeholders

• Shape strategic scientific communication plans, and support presentation and publication of research in peer-reviewed journals

• Support the assessment of business development opportunities against payer and HTA requirements to identify risks, evidence gaps, and access considerations

Education & Experience

• 7+ years of Pharma Industry experience with 4+ years of experience in HEOR roles in pharmaceutical companies or consulting, and at least 2 years of direct experience with patient-relevant outcomes research

• Advanced degree in health economics, outcomes research, epidemiology, public health, health services research, pharmacy, or a related scientific discipline

• Strong understanding of market access, value and global HTA frameworks

• Experience supporting the development and execution of patient-relevant outcomes strategies to meet payer and HTA requirements

• Prior experience contributing to the evaluation, development, and validation of PRO measures to support regulatory, payer, and HTA decision making

• Experience supporting HTA submissions, value dossiers, and patient-relevant briefing books

• Ability to collaborate and build alignment across cross-functional stakeholders, including Value & Access, Commercial, Medical Affairs, Clinical Development & Regulatory Affairs

• Ability to manage multiple initiatives and effectively prioritize in a dynamic, fast-paced environment

• Developing expertise within the patient-reported outcomes field, with a growing professional network

• Experience supporting engagement with external stakeholders, including HTA agencies, payers, health economists, clinical experts, and patient advocacy organizations

• Rare disease experience preferred

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.

Ireland Safety Responsibility

Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initi

Jazz Pharmaceuticals, Inc.

Senior Director, Sr. Corporate Counsel, IP

**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.

The Senior Director, Corporate Counsel, Intellectual Property (IP), will develop and execute robust global patent and IP strategies for Jazz's products, product candidates, platform technologies, and newly acquired or licensed assets, ensuring alignment with corporate growth objectives and maximizing the value of the company's innovation portfolio. In addition, the Sr. Corporate Counsel, IP will play a critical role in supporting Jazz's corporate development objectives by leading intellectual property due diligence, integration planning, and strategic portfolio development across acquisitions, licensing transactions, collaborations, and other strategic business opportunities.

This individual will serve as a trusted advisor to Corporate Development, R&D, Business Development, and senior leadership, providing sophisticated IP analyses that inform transaction structures, valuation, risk assessment, and post-transaction integration strategies. Initially, this position reports directly to the VP of Legal & IP.

**Key Job Responsibilities**

- Serve as a critical IP advisor to Corporate Development teams, providing strategic support for acquisitions, licensing transactions, collaborations, joint ventures, divestitures, and other strategic transactions.
- Conduct comprehensive IP due diligence for potential acquisitions, in-licensing opportunities, collaborations, and strategic partnerships, including freedom-to-operate evaluations, portfolio strength analyses, exclusivity assessments, and identification of material IP risks and value drivers.
- Prepare and communicate clear, actionable diligence findings and recommendations to executive leadership, transaction teams, and legal leadership to support decision-making, valuation, negotiation strategy, and transaction structuring.
- Partner closely with Transformation Office and cross-functional stakeholders to develop and execute post-transaction integration strategies, including patent portfolio optimization, ownership alignment, prosecution strategy harmonization, and identification of opportunities to enhance long-term asset value.
- Develop and execute sophisticated global patent strategies that support business objectives, strengthen competitive positioning and exclusivity, and maximize the value of both internally developed and externally acquired or licensed assets.
- Build and manage high-value global patent portfolios from invention capture through patent issuance and lifecycle management, ensuring alignment with product development and commercialization strategies.
- Provide strategic input into transaction documents, including licensing agreements, collaboration agreements, acquisition agreements, due diligence reports, representations and warranties, IP covenants, and integration-related provisions.
- Build effective partnerships with stakeholders across research, development, commercial, regulatory, business development, and corporate development functions to deliver practical, business-focused IP advice.
- Conduct freedom-to-operate, infringement, validity, patentability, and competitive landscape analyses and develop risk mitigation strategies in support of business objectives.
- Effectively manage outside counsel supporting patent prosecution, IP due diligence, litigation, opinions, and other strategic matters to ensure high-quality, efficient, and commercially focused outcomes.
- Counsel senior management and cross-functional teams on intellectual property risks, opportunities, exclusivity strategies, competitive positioning, and portfolio optimization initiatives.
- Review publications, presentations, press releases, and other public disclosures to protect patent rights and support external communication strategies.
- Advise on and/or lead contentious and adversarial matters involving company assets, including patent litigation, IPRs, PGRs, European oppositions, and related proceedings.
- Lead and contribute to departmental initiatives aimed at enhancing IP operations, diligence capabilities, portfolio management processes, and overall organizational effectiveness.

**Required Knowledge, Skills, and Abilities**

- Fully qualified U.S. Patent Attorney or Agent with 10+ years of relevant intellectual property experience in the biopharmaceutical industry, including substantial in-house experience supporting corporate development, licensing, collaborations, mergers and acquisitions, or other strategic transactions.
- Undergraduate degree in biological sciences, biochemistry, chemistry, or another discipline relevant to pharmaceuticals, biotechnology, or life sciences; advanced degree preferred.
- Significant experience leading IP due diligence for acquisitions, licensing transactions, collaborations, venture investments, and other strategic corporate transactions.
- Demonstrated experience evaluating, integrating, and maximizing the value of acquired or licensed patent portfolios and intellectual property assets.
- Deep expertise in patent portfolio development, lifecycle management, exclusivity strategies, freedom-to-operate analyses, and competitive intelligence.
- Ability to work in dynamic, fast-paced team environment; flexible and responsive self-starter who can operate independently as well as collaboratively across the business.
- Excellent written, verbal, and presentation skills, with the ability to distill complex legal and scientific concepts into clear business recommendations for senior executives.
- Strategic thinker who anticipates business challenges, identifies opportunities to create and protect enterprise value, and develops creative, practical solutions.
- Proven ability to influence decision-making across cross-functional teams and build trusted partnerships with executives, researchers, commercial leaders, and corporate development professionals.
- Strong project management, prioritization, and organizational skills with the ability to manage multiple high-impact initiatives simultaneously.
- Experience in patent litigation, post-grant proceedings, oppositions, and other adversarial matters is a plus.

\#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: $259,200.00 - $388,800.00

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>).

Senior Manager, Research Laboratory Operations

**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**

We are seeking a highly organized, collaborative, and motivated Senior Manager, Research Laboratory Operations to lead our research laboratory in Durham, NC, and actively participate as a hands-on scientific partner on key research projects. Reporting directly to the Chief Scientific Officer (CSO), Oncology, this dual-function role is pivotal in ensuring the smooth, safe, and compliant daily operation of our research facility while directly contributing scientific expertise to advance our pipeline.

The ideal candidate will seamlessly blend strong laboratory operations leadership with a solid background in drug discovery, specifically offering hands-on experience in screening methodologies, biochemical assays, and cell culture.

**Key Responsibilities**

1. Research Laboratory Operations & Management (approx. 60%)

- Laboratory Management: Oversee the daily operations of the Durham research lab, maintaining an efficient, highly organized, safe, and fully functional environment for the scientific team.
- Equipment & Inventory: Manage the procurement, maintenance, decontamination, calibration, and repair of all laboratory equipment (including biosafety cabinets, live cell imaging systems, liquid handlers, and other analytical instruments). Oversee inventory and supply chain for lab consumables, reagents, and specialized materials.
- Safety & Compliance: Ensure all laboratory activities comply with institutional, local, state, and federal safety regulations (including OSHA and biosafety guidelines). Oversee lab safety protocols, hazardous waste disposal, and general laboratory hygiene.
- Budget & Vendor Management: Manage laboratory spending, assist in tracking the operational budget, process purchase approvals, and coordinate with external vendors, contractors, and service providers.
- Cross-Functional Collaboration: Partner with facilities management, EH&S, procurement, and R&D project management to coordinate space planning, equipment utilization, and continuous operational improvements.

2. Scientific Project Contribution (approx. 40%)

- Assay Development & Execution: Support ongoing pipeline programs by conducting hands-on in vitro research, with a strong focus on screening platforms and biochemical assays.
- Experimental Support: Manage cell cultures of cancer and normal cell lines; execute mechanism of action, target validation, and biomarker studies for therapeutic candidates.
- Data & Documentation: Document and archive experimental protocols, raw data, analyses, and conclusions according to established laboratory procedures and electronic lab notebook (ELN) standards.
- Scientific Communication: Actively participate in the communication of research findings, presenting data in internal project team meetings, contributing to conference abstracts, and supporting the preparation of manuscripts for publication.

**Required Knowledge, Skills, and Abilities (Qualifications**)

- Education: MS or PhD (or equivalent practical experience) in Biology, Biochemistry, Oncology, or a related scientific discipline.
- Industry Experience: Proven track record of successfully managing a research laboratory within the pharmaceutical or biotechnology industry.
- Technical Skills: Hands-on experience running, troubleshooting, and supporting screening platforms and biochemical assays is highly preferred. Competency in mammalian cell culture and standard molecular biology techniques is required.
- Therapeutic Area: Previous background or experience in oncology research is preferred, but not required.
- Leadership & Organization: Exceptional organizational, communication, and problem-solving skills, with a positive, "hands-on" approach to the role. Demonstrated success working in a matrixed, cross-functional environment.

**Physical Demands & Work Environment**

- Requires the ability to perform routine laboratory work, stand or sit at a biosafety cabinet or lab bench for extended periods, and utilize computer systems.
- May occasionally lift objects up to 25 pounds.
- **This is a full-time, laboratory-based, on-site role in our Durham, NC facility.**

\#LI-SM1

\#LI-onsite

*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: $136,000.00 - $204,000.00

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>).

North Carolina

Executive Director, Assistant General Counsel, Intellectual Property

**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:**

The Executive Director, Assistant General Counsel, Intellectual Property (IP), will be a key leader within the Jazz Legal Function. Reporting to directly to the VP, Legal & IP, the successful candidate will develop and execute robust global patent and IP strategies for Jazz's products, product candidates, platform technologies, and newly acquired or licensed assets, ensuring alignment with corporate growth objectives and maximizing the value of the company's innovation portfolio. In addition, the Executive Director, IP will play a critical role in supporting Jazz's corporate development objectives by leading intellectual property due diligence, integration planning, and strategic portfolio development across acquisitions, licensing transactions, collaborations, and other strategic business opportunities.

The Executive Director, IP will build effective relationships with relevant stakeholders at all levels of the global organization and across all phases of research, drug development & commercialization to provide clear, strategic business-enabling IP advice. This position will supervise other members of the IP team, including those responsible for day-to-day management and protection of our IP assets

**Essential Functions/Responsibilities**

- Serve as a critical advisor to senior leadership, R&D, Commercial and Corporate Development teams to provide clear, strategic business-enabling advice on complex IP matters to advance corporate objectives.
- Directly and indirectly supervise those IP team members supporting programs and projects across the Jazz portfolio.
- Develop and execute sophisticated global patent strategies that support business objectives, strengthen competitive positioning and exclusivity, and maximize the value of both internally developed and externally acquired or licensed assets.
- Conduct comprehensive IP due diligence for potential acquisitions, in-licensing opportunities, collaborations, and strategic partnerships, including freedom-to-operate evaluations, portfolio strength analyses, exclusivity assessments, and identification of material IP risks and value drivers.
- Identify opportunities to strengthen the company’s IP portfolio through engagement with project teams and collaboration partners and leveraging a deep understanding of patent law and the competitive landscape across the portfolio.
- Render freedom-to-operate, infringement, validity analyses, risk evaluation, and mitigation strategies for individual programs, technologies, and tools.
- Provide strategic input into transaction documents, including licensing agreements, collaboration agreements, acquisition agreements, due diligence reports, representations and warranties, IP covenants, and integration-related provisions.
- Effectively manage outside counsel supporting patent prosecution, IP due diligence, litigation, opinions, and other strategic matters to ensure high-quality, efficient, and commercially focused outcomes.
- Counsel and train internal clients, including other members of the Legal Department and senior management, on intellectual property risks and opportunities in patentability, freedom-to-operate, infringement, validity, and regulatory exclusivity analyses.
- Review publications, presentations, press releases and other materials for clearance.
- Advise on and/or lead contentious and adversarial matters involving company assets, including patent litigation, IPRs, PGRs, European oppositions, and related proceedings.
- Actively lead and participate in IP team and Legal department initiatives, identifying opportunities to enhance effectiveness of IP and Legal department practice and operations.

**Required Knowledge, Skills, and Abilities**

- Experience in managing IP practitioners and staff.
- Significant experience in IP due diligence and licensing and collaboration agreements.
- Experience in adversarial and administrative proceedings is a plus.
- Practical problem solver with ability to facilitate and contribute to collaborative decision-making processes and work effectively on cross-functional teams in order to achieve business objectives.
- Ability to work in dynamic, fast-paced team environment, flexible and responsive self-starter with the ability to act independently as well as collaboratively across the business.
- Excellent oral and written communication skills with experience presenting and concisely communicating complex information to all levels of an organization.
- Approach IP creation and protection with a strategic mindset by anticipating internal and/or external business challenges, competitive and legal risks and opportunities and offering creative solutions.
- Ability to manage outside counsel and other external resources for quality work product, value, and efficiency.
- Strong prioritization skills and ability to effectively manage a diverse workload
- Embraces and fosters a culture that reflects a strong commitment to diversity, equity, inclusion, and community

**Required Education and Licenses**

- Fully qualified US Patent Attorney with 12+ years relevant IP experience in the biopharmaceutical industry, with significant in-house or combined in-house and law firm experience
- Undergraduate degree in biological science, biochemistry, chemistry, or other field relevant to pharmaceuticals, life sciences or biotechnology; Advanced degree preferred.

\#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: $288,000.00 - $432,000.00

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>).

IDEAYA Biosciences

Senior Patent Agent

**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

Position Summary:

IDEAYA Biosciences is seeking an experienced Senior Patent Agent. Reporting directly to the Vice President of Intellectual Property, this role will support the Company’s intellectual property function to protect the Company’s small molecule product candidates. The ideal candidate will enjoy working collaboratively with inventors across various departments, senior scientific leaders, and the legal team.

This position is based in our South San Francisco headquarter offices and required to be onsite four days per week per our company policy.

Job Description

**What you’ll do:**

- Global IP portfolio management including preparing and prosecuting patent applications focusing on small molecules
- Partner with cross department teams to develop a deep understanding of project technology, identify patentable inventions through regular interactions with project teams, and implement IP protection strategies
- Identify and evaluate a range of complex risks (e.g., patentability, infringement, validity) and crafting innovative business-oriented mitigation strategies
- Conduct freedom to operate reviews, analyze third-party patent positions, and guide IP strategy
- Maintaining strong knowledge of patent case law, rules and regulations before the U.S. Patent & Trademark Office as well as other jurisdictional IP offices
- Manage outside legal counsel and ensure compliance with global IP laws and regulations
- Monitor and analyze competitive IP landscape and IP trends to assess risk and opportunities
- Engage in clear communication, both oral and written, to all levels of the organization with a willingness to listen and learn from others
- Assist in managing IP department’s administration, infrastructure and policies
- Conduct IP diligence and provide other IP support for business development opportunities

**Requirements:**

- Ph.D. in Chemistry, preferably Organic Chemistry, or Master’s in Organic Chemistry
- Registered before the United States Patent and Trademark Office
- 7+ years of patent agent experience in pharmaceutical small molecules (patent preparation and prosecution), including preferably 2-3 years in-house experience
- Proven track record developing and implementing patent strategies with demonstrated success securing meaningful patent protection for products and related technology
- Excels at working independently and proactively with minimal direction, has strong organizational skills, and the ability to prioritize and balance competing projects and responsibilities
- Must have strong analytical skills and the ability to interpret complex scientific and legal information
- Proficiency in using scientific and IP databases
- Must have excellent written and verbal communication skills and attention to detail

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 Senior Patent Agent is $198,000 - $245,000. 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.

Contractor Max Bill Rate Per Hour

Senior Principal Research Scientist, Computational Chemistry

**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.

Position Summary:

We are seeking an accomplished Senior Principal Research Scientist in Computational Chemistry with significant pharmaceutical industry experience to join our multidisciplinary small molecule drug discovery organization. This is a senior individual contributor role for a highly experienced computational chemist with a strong track record of advancing pharmaceutical discovery programs through hands-on scientific impact.

The successful candidate will support discovery project teams across target identification, hit discovery, lead optimization, and drug candidate selection. The role requires a high degree of independence, technical depth, and scientific judgment. The candidate will apply modern computational chemistry approaches to directly inform medicinal chemistry design and project decision-making. We are looking for a creative, detail-oriented scientist with a passion for drug discovery and a collaborative mindset.

As part of the drug discovery team, the candidate will contribute directly to target assessment and druggability analysis, perform virtual screening and structure-based modeling, and work closely with medicinal chemists to design compounds with improved potency, selectivity, functional activity, and developability (e.g., ADME/DMPK). In addition to hands-on contributions, the candidate will mentor other scientists and share best practices to amplify the impact of computational chemistry across project teams.

This position is based in our South San Francisco headquarter office and required to be onsite four days per week per our company policy.

Location: South San Francisco, CA.

Reporting to: Director & Head of Computational Chemistry

Job Description

**What you’ll do:**

- Lead structure-based drug design meetings with medicinal chemists and provide senior-level, hands-on drug design and computational chemistry support to small molecule drug discovery project teams
- Contribute to programs from target identification through lead optimization and drug candidate selection
- Apply structure-, ligand-, and fragment-based modeling to guide medicinal chemistry design
- Use molecular dynamics, free energy methods, quantum chemistry, and cheminformatics to address complex design and prioritization questions
- Translate computational analyses into clear, actionable compound design recommendations
- Serve as a highly experienced computational contributor and scientific advisor within project teams
- Mentor and coach other scientists in structure-based drug design through technical guidance and scientific discussion
- Evaluate new computational methods, tools, and workflows and apply them when they add clear value
- Maintain scientific rigor, reproducibility, and best practices in an industry drug discovery environment

**Requirements:**

- PhD in Computational Chemistry or a related discipline with 9+ years of pharmaceutical or biotechnology industry experience
- Strong understanding of small molecule drug discovery and medicinal chemistry principles
- Demonstrated expertise in structure-, ligand-, and fragment-based drug discovery
- Expertise in free energy perturbation, molecular dynamics, quantum mechanics, cheminformatics, and ligand affinity estimation methods
- Proven ability to independently deliver computational work that influences medicinal chemistry decisions and project outcomes
- Ability to manage priorities across multiple discovery programs
- Excellent oral and written communication skills
- Experience applying machine learning or AI methods to molecular design, property prediction, or compound prioritization
- Experience with Schrödinger modeling software and others (e.g., MOE, OpenEye)
- Programming, scripting, statistics, and data analysis experience applied to drug discovery
- Experience working on challenging target classes, including protein–protein interactions and allosteric pockets
- Track record of contributing to discovery programs that advance high-quality small molecule drug candidates

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 Senior Principal Research Scientist, Computational Chemistry is $196,000 - $242,000. 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.

Principal Research Scientist, Medicinal Chemistry

**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 teamwork to move science forward. For more information, please see www.ideayabio.com.

Location: South San Francisco

Position Summary:

We are seeking a talented and highly motivated individual with significant pharmaceutical industry experience to join our multidisciplinary team as a discovery medicinal chemist. The successful candidate will impact programs by being highly productive in lab and by rationally proposing target molecules that overcome liabilities to deliver clinical candidates molecules. You will be a part of dynamic, cross-functional teams that successfully deliver drug discovery pipeline goals. The responsibilities will include, but not be limited to, those listed below.

This position is based in our South San Francisco headquarter offices and required to be onsite five days per week per our company policy.

Reporting to: Vice President, Medicinal Chemistry

Job Description

**What you’ll do:**

- Apply modern synthetic techniques to prepare complex chemical targets to advance cutting-edge oncology programs and deliver high-quality molecules at a very productive rate
- Design high-confidence reaction sequences that avoid known liabilities and reduce difficult purifications
- Rapidly gather reaction information and troubleshoot problematic transformations
- Plan ahead and multitask in and out of the lab to maintain high productivity
- Deliver molecules on scales from 10 mg to \> 25 g
- Help manage external synthetic chemistry resources to high productivity
- Follow SAR data and leverage medicinal chemistry knowledge to propose targets that address critical issues within a chemical series
- Champion design and synthesis efforts into new directions as needed to achieve goals
- Clearly and concisely communicate results and strategy to inform and influence others
- Use structure-based design skills and modern computational tools to design targets with improved affinity and selectivity profiles

**Requirements:**

- Ph.D. in synthetic organic chemistry with 3-8 years of pharmaceutical industry medicinal chemistry experience
- Excellent scientific expertise in synthetic organic chemistry, including asymmetric reactions and modern cross-coupling techniques, strong knowledge of modern chemistry literature and in-depth knowledge of a wide range of purification and spectroscopic characterization techniques
- Demonstrated ability to maintain high productivity in the lab and synthesize complicated chemical structures at the pace required to impact medicinal chemistry programs while maintaining high safety standards
- Ability to develop new chemistry that is both practical and scalable
- Ability to regularly troubleshoot synthetic problems and provide practical and creative solutions
- Ability to keep good scientific records
- Ability to identify the most critical issues with the lead chemical matter for a project, associate those issues with chemical functionality or physicochemical properties within the series, and strategically focus most target design efforts toward fixing these issues
- Ability to multi-task and set priorities in a fast-paced and dynamic environment while demonstrating a positive attitude and superior work ethic
- Ability to work well in diverse, multi-disciplinary teams
- Demonstrate excellent oral and written communication skills
- Strong knowledge of medicinal chemistry concepts, including structure-based target design, SAR-driven target design, multi-parameter optimization, physicochemical properties of drugs, and ADME and pharmacological principles applied to drug discovery
- Ability to use modern computational tools to better understand trends in biological data found within a series of drug-like molecules and to understand the underlying principles governing ligand binding
- Desire to continually learn drug discovery concepts and structure-based design concepts and to stay current with the field while mentoring others

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 Principal Research Scientist, Medicinal Chemistry is $177,000 - $218,000. 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.

Senior Research Scientist, Medicinal Chemistry

**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 teamwork to move science forward. For more information, please see www.ideayabio.com.

Location: South San Francisco, CA

Position Summary:

We are seeking a talented and highly motivated individual with significant pharmaceutical industry experience to join our multidisciplinary team as a discovery medicinal chemist. The successful candidate will impact programs by being highly productive in lab and by rationally proposing target molecules that overcome liabilities to deliver clinical candidates molecules. You will be a part of dynamic, cross-functional teams that successfully deliver drug discovery pipeline goals. The responsibilities will include, but not be limited to, those listed below.

This position is based in our South San Francisco headquarter offices and required to be onsite five days per week per our company policy.

Reporting to: Vice President, Medicinal Chemistry

Job Description

**What you’ll do:**

- Apply modern synthetic techniques to prepare complex chemical targets to advance cutting-edge oncology programs and deliver high-quality molecules at a very productive rate
- Design high-confidence reaction sequences that avoid known liabilities and reduce difficult purifications
- Rapidly gather reaction information and troubleshoot problematic transformations
- Plan ahead and multitask in and out of the lab
- Deliver molecules on scales from 10 mg to \> 25 g
- Help manage external synthetic chemistry resources to high productivity
- Follow SAR data and leverage medicinal chemistry knowledge to propose targets that address critical issues
- Use emerging structure-based design skills to design targets with improved affinity and selectivity profiles
- Clearly and concisely present results in various forums

**Requirements:**

- Ph.D. in synthetic organic chemistry with 0-3 years of pharmaceutical industry medicinal chemistry experience
- Excellent scientific expertise in synthetic organic chemistry, including asymmetric reactions and modern cross-coupling techniques, strong knowledge of modern chemistry literature and in-depth knowledge of a wide range of purification and spectroscopic characterization techniques
- Ability to keep good scientific records
- Demonstrated ability to maintain high productivity in the lab and synthesize complicated chemical structures at the pace required to impact medicinal chemistry programs while maintaining high safety standards
- Ability to develop new chemistry that is both practical and scalable
- Ability to regularly troubleshoot synthetic problems and provide practical and creative solutions
- Ability to keep good scientific records
- Demonstrate excellent oral and written communication skills
- Ability to multi-task and set priorities in a fast-paced and dynamic environment while demonstrating a positive attitude and superior work ethic
- Ability to work well in multi-disciplinary teams
- Level-appropriate knowledge of medicinal chemistry concepts, including structure-based target design, SAR-driven target design, multi-parameter optimization, physicochemical properties of drugs, and ADME and pharmacological principles applied to drug discovery
- Desire to continually learn drug discovery concepts and structure-based design concepts and to stay current with the field

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 Senior Research Scientist, Medicinal Chemistry is $148,000 - $183,000. 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. This position requires you to work onsite in the office at the Company’s facilities for training & meetings, with work-from-home flexibility, and the Company requires that all employees working in its facilities be fully vaccinated (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for medical or religious reasons, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.

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.

Senior Principal Research Scientist, Protein Sciences

**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:

We are seeking an accomplished and highly collaborative Senior Principal Research Scientist to make significant hands-on contributions to our Protein Sciences function while supervising and developing a small team of research associates and PhD-level scientists. This role is intended for an experienced laboratory scientist who enjoys solving challenging protein-production problems, supporting multiple drug-discovery programs, and coordinating internal and external scientific work.

The successful candidate will bring deep expertise in recombinant protein expression, purification, and characterization, including extensive experience with bacterial and insect-cell expression systems. This individual will directly contribute to the delivery of high-quality proteins and protein complexes for biochemical, biophysical, structural, and screening applications across a diverse portfolio of drug-discovery programs.

This opportunity is particularly well suited to an established career scientist who wants to remain actively engaged at the bench while expanding their impact through technical problem-solving, supervision and development of scientists, CRO coordination, and cross-functional collaboration.

This position is based in our South San Francisco headquarter offices and required to be onsite four days per week per our company policy.

Reporting to: Vice President, Lead Discovery

Job Description

**What you’ll do:**

- Contribute actively in the laboratory while coordinating the day-to-day work and priorities of the Protein Sciences team in alignment with drug-discovery program needs.
- Develop and execute protein-expression and purification strategies for challenging proteins and protein complexes using bacterial, insect-cell, and other appropriate expression systems.
- Perform and oversee construct design, expression testing and optimization, protein purification, characterization, and troubleshooting, particularly for challenging proteins and protein complexes.
- Ensure delivery of high-quality, fit-for-purpose protein reagents for biochemical, biophysical, structural, and screening applications.
- Partner closely with Bioassays, Biophysics, Structural Biology, Biology, Medicinal Chemistry, and Data Science to develop integrated experimental strategies and translate results into program decisions.
- Supervise, mentor, and develop research associates and PhD-level scientists, providing practical experimental guidance while enabling appropriate scientific independence.
- Identify, engage, and coordinate CROs for protein expression, purification, characterization, and related activities; establish clear work plans, review data quality, and ensure timely delivery of fit-for-purpose reagents.
- Communicate scientific strategies, findings, risks, and recommendations clearly to project teams and research leadership.

**Requirements:**

- PhD with 9+ years’ hands-on expertise in recombinant protein production using bacterial and insect-cell expression systems; experience with mammalian expression is desirable.
- Demonstrated ability to independently develop and troubleshoot purification strategies for challenging proteins, protein complexes, and multiple construct variants.
- Hands-on experience with protein characterization methods such as SDS-PAGE, Western blotting, concentration determination, analytical SEC, thermal-stability methods, and assessment of aggregation and sample quality (i.e. SEC-MALS).
- Experience selecting and managing CROs or other external partners for protein production and characterization, including technical transfer, data review, troubleshooting, and quality assessment.
- Experience supervising and developing research associates and PhD-level laboratory scientists.
- Excellent oral, graphical, and written communication skills
- Familiarity with global proteomics, phosphoproteomics, chemical biology, or chemoproteomics is desirable but not required.

**Travel required:** Maybe for a conference

**Percentage of time in a year:** Less than 1%

**Domestic/International:** Domestic

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 Senior Principal Research Scientist, Protein Sciences is $180,000 - $223,000. 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.

Eli Lilly and Company

Engineering Technician - Night shift

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

**Engineering Technician – Night Shift**

**At Lilly**, we unite caring with discovery to make life better for people around the world. Headquartered in Indianapolis, Indiana, we are a global leader in healthcare, committed to discovering life-changing medicines, advancing disease management, and supporting our communities through philanthropy and volunteerism. We put people first and strive to make a meaningful impact every day.

**Position Summary:**

The Engineering Technician at our Concord, NC facility plays a key role in supporting Parenteral Operations, our customer, by ensuring the efficient setup and operation of Pre-Filled Syringe and Isolator Equipment. This position requires hands-on engineering maintenance expertise to assist with equipment setup, operational support, troubleshooting, repairs, and ongoing maintenance.

The ideal candidate will demonstrate a strong understanding of customer needs, collaborate effectively with internal teams, and provide responsive, courteous support. Success in this role requires technical proficiency, problem-solving skills, and a commitment to delivering excellent customer service in a dynamic manufacturing environment.

**Key Responsibilities:**

- Promote a safety-first, quality-always culture in all tasks and interactions
- Improve equipment uptime, line efficiency, and overall equipment effectiveness (OEE)
- Perform condition monitoring, troubleshooting, and provide operational support
- Diagnose and repair precision filling equipment with strong mechanical aptitude
- Collaborate with engineering and production teams to resolve equipment issues promptly
- Assist with equipment setup and changeovers to support production needs
- Adhere to all GMP and quality standards
- Must have the ability to quickly and accurately diagnose the root cause of a problem and properly implement corrective actions to minimize downtime
- Accurately document maintenance activities and corrective actions
- Support cross-functional tasks and assist outside primary responsibilities as needed
- Work independently and manage priorities under pressure

**Minimum Requirements:**

- High School / GED minimum
- Visa Sponsorship: Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

**Basic Qualifications:**

- High school diploma or GED
- Minimum of 5 years’ experience in production maintenance
- Strong mechanical aptitude and hands-on technical skills
- Proficient with basic hand tools
- Detail-oriented with a commitment to quality and precision
- Familiarity with safety protocols and proper PPE usage
- Physically able to stand for extended periods
- Effective team player with strong interpersonal skills
- Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

**Preferred Qualifications:**

- Associate’s degree or technical certification in a related field is a plus
- Knowledge of FDA and GMP regulations
- Experience operating high-speed, automated production equipment, preferably Syringe/Vial Filling systems utilizing Isolator technology
- Ability to quickly learn and apply new procedures
- Experience working in a classified manufacturing environment
- Familiarity with Computerized Maintenance Management Systems (CMMS) platforms
- Strong verbal and written communication skills
- Customer-oriented mindset with a proactive approach
- Analytical thinker with strong problem-solving abilities

**Additional Information:**

- Flexibility to work overtime or adjust schedule based on production demands
- Following a Monday–Friday, 8-hour training period, the role transitions to a 12-hour 2-2-3-**night shift** schedule
- Willing and able to respond to off-hour emergencies as needed
- Open to travel for training and professional development opportunities

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$21.27 - $41.25

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Nurix Therapeutics

Senior Research Associate, DNA Encoded Library Technology ~ Contract

**_Company_**

*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.*

Senior Research Associate, DNA Encoded Library Technology – Nurix Brisbane

**Position**

We are seeking a talented and motivated chemist to join our Discovery Chemistry team and contribute to the design and synthesis of DNA-encoded libraries (DELs). This hands-on position offers the opportunity to shape Nurix’s DEL-based lead discovery platform, working at the interface of chemistry, biology, and automation. Key responsibilities:

- Design and validate novel DEL library builds.
- Develop and bring in new DNA-compatible chemical transformations that can widen the DEL chemical space.
- Construct DEL libraries to support the in-house library production efforts.
- Work with external partners to support our DEL synthesis and hit follow up strategies.
- Engage in cross-functional team discussions that support DEL screening, data analysis, machine learning and hit-optimization.
- Contribute to platform automation and technology development efforts.
- Present results, document workflows, and contribute to scientific and strategic planning within the Discovery Chemistry organization.

**Education and Experience**

- B.S. or higher in Chemistry, Biochemistry, or Medicinal Chemistry with 5 years of industrial experience (title determined by experience).
- Strong background in synthetic organic chemistry.
- Hands-on laboratory experience synthesizing DNA encoded libraries.
- Familiar with the overall DNA-Encoded Library Technology workflow operations.
- Experience analyzing and purifying DNA-conjugates using common analytical tools (LCMS/HPLC).

**Added Qualifications**

- Experience working in the drug discovery field – drug design, synthesis, and SAR based hit-to-lead optimization.
- Experience working with high-throughput analytical and purification systems relevant to DEL-applications.
- Experience working with molecular biology tools (PCR, qPCR, Western Blot).

**Fit with Nurix Culture and Values**

- Collaborative and team-oriented, eager to share expertise and learn from others.
- Solution-driven with a hands-on and resourceful approach.
- Adaptable and comfortable in a fast-paced, interdisciplinary environment.
- Committed to scientific excellence and the shared goals of the team.

Location: Brisbane, CA

**Salary Range:** $119K – $139K

**Application Process**

Nurix is an Equal Opportunity Employer offering a competitive salary and benefits package. Applicants should be legally entitled to work for any employer in the US.

**Note to Employment Agencies:**  Please do not forward any agency resumes. Nurix will not be responsible for fees related to unsolicited resumes.

Nurix Therapeutics, Inc. is committed to protecting and respecting your privacy and personal information, including information collected by Nurix when you apply for a job with Nurix or in the course of your employment with Nurix. By applying for a position at Nurix, you agree to our collection and use of personal information as described in our Privacy Policy ([https://www.nurixtx.com/privacy-policy/](<https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.nurixtx.com%2Fprivacy-policy%2F&data=05%7C01%7CEKwong%40nurixtx.com%7C598063b43c7346495d2908db8a013c96%7C1c966021d55145e489a5849f81b69208%7C0%7C0%7C638255510177936421%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=ZGFKSH61Un4AiGchAOr7elttfiKtOQB7huPs0DlQY54%3D&reserved=0>)).

Associate Director, Regulatory & Medical Writing

**Associate Director, Regulatory & Medical Writing**

*Help shape how Nurix communicates its science to health authorities and the world. As Associate Director, Regulatory & Medical Writing, you’ll independently lead the authoring, review, and approval of critical regulatory documents across our pipeline — from clinical protocols to health authority submissions. It’s a chance to bring clarity and strategic messaging to the documents that move our therapies through development and toward patients.*

**Position Description**

**The Opportunity**

- Author and manage authoring of Regulatory & Medical Writing documents together with cross-functional collaborators; ensure content consistency within a document and across documents for a particular asset, including the development of strategic messaging and data presentation in accordance with Nurix standards and health authority requirements, for documents such as:
  - Clinical study protocols and clinical protocol amendments
  - Clinical study reports
  - Investigator’s brochures and annual updates
  - IND submissions and annual reports
  - Lay-person summaries
  - Integrated summary reports
  - Clinical, nonclinical, and multidisciplinary information amendments
  - NDA, BLA, MAA, and (e)CTD submissions
  - Risk Management Plans
  - Health authority responses
  - Briefing documents, ODDs, BTDs/PRIME, FTD, and similar designations
- Review, edit, and QC documents developed by other authors or medical writers
- Manage the author, review, and approval process for multiple deliverables at a given time; ensure quality and timely completion, with attention to consistency of content, messaging, format, and style
- Lead Regulatory & Medical Writing activities for assigned programs, including partnering with the Head of Regulatory & Medical Writing on resource planning, document timelines, issue resolution, and process improvement initiatives
- Represent Regulatory & Medical Writing on interdisciplinary teams for assigned programs/projects, providing strategic input and status updates
- Manage external Regulatory & Medical Writing resources for assigned programs/projects, as needed

**What You’ll Bring**

- 6 to 8+ years of Regulatory and/or Medical Writing, or other relevant pharmaceutical/biotechnology industry experience in the Clinical Development phase, authoring and overseeing documents submitted to health authorities
- Experience identifying and interpreting information/data for inclusion in documents such as clinical study protocols, Investigator’s Brochures, clinical study reports, Lay Summaries, and ICFs
- Involvement with ex-US submissions for clinical trial applications and marketing applications is a plus
- Ability to work effectively and lead in cross-functional working groups
- Excellent communication skills, organizational skills, and attention to detail
- Adaptable and flexible, willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism
- Knowledge of health authority requirements, ICH guidelines, and submission-ready standards relevant to document authoring, including eCTD and submission lifecycle management
- Proficiency in project planning tools such as MS Project or Smartsheet, collaborative authoring or document review tools, and Veeva RIM Suite
- Expertise in Microsoft Word (including use of customized toolbars/templates) and document management systems

**Salary Range:**  $216,400 - $234,800

*The posted range applies to roles based in the San Francisco Bay Area and reflects local market conditions. Where an offer lands within that range depends on the candidate’s relevant experience, technical expertise, and how their background aligns with the role’s requirements.*

**Location:** Onsite – Brisbane, CA

**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

**About Nurix Therapeutics**

*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.*

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

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)

Senior Manager/Associate Director, Regulatory Affairs (Strategy, Hematology Oncology)

**Senior Manager / Associate Director, Regulatory Affairs (Strategy, Hematology Oncology)**

*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.*

**Job Summary:**

In this role, you will be a core member of the Regulatory team and will be responsible for helping build and execute on global regulatory strategy, objectives, policies and programs pertaining to development and future marketing of products.

**Responsibilities:**

- Provides regulatory strategic direction and support for assigned global development programs/development program activities
- Assists Sr. Regulatory Affairs staff with their development program activities and deliverables
- Designs and implements regulatory strategies with Regulatory Affairs staff to obtain and maintain product investigative and marketing applications for assigned programs, as well as their life cycle management
- Acts as regulatory representative on early and/or late phase clinical studies, ensuring compliant execution of trials
- Strong competency in understanding regulatory requirements and emerging regulatory landscapes associated with US and global regulatory authorities
- Experienced in responding to inquiries from global regulatory authorities as well as the preparation and conduct of meetings with global regulatory authorities
- Assist in the preparation and maintenance of Annual Reports, Development Safety Update Reports (DSURs), Investigator’s Brochures and other documents required for INDs, CTAs, NDAs and other related regulatory development and marketing applications
- Assist in the cataloging and maintenance of regulatory application submissions
- Conduct research and stay up-to-date on regulatory requirements and changes
- Collaborate with cross-functional teams to ensure product compliance throughout the development lifecycle
- Monitor and assess regulatory risks and develop mitigation strategies
- Oversee quality assurance processes to ensure compliance with regulatory standards
- Review SOPs pertaining to Regulatory
- 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

**Experience and Skills:**

- Bachelor's degree in life-sciences or related scientific discipline; advanced degree preferred Manager:
- Must have minimum of 8 years in Regulatory affairs strategy
- 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
- Ability to read, analyze and interpret scientific and technical information, as well as regulatory
- Ability to understand and explain detailed regulatory affairs and compliance programs and/or to effectively present information to senior regulatory management, other departments or external
- Ability to comply with changing regulatory
- 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

**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

**Salary Range:** SM $187,800 - $208,638 AD $199,500 - $231,200

**Location:**  Brisbane, CA - Onsite

Research Associate II, Bioanalytical/In Vitro ADME/DMPK

**Research Associate II, Bioanalytical/In Vitro ADME/DMPK**

**_Company_**

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.

**Position**

Nurix Therapeutics is searching for a motivated **Research Associate** II to join our **Bioanalytical-In Vitro DMPK** team. The successful candidate will contribute to the bioanalytical efforts to support Nurix drug discovery programs involving in vivo and in vitro studies. We are seeking a highly motivated research associate to characterize the in vitro and in vivo ADME properties of drug candidates. The primary responsibilities will be to conduct bioanalysis for in vivo samples and to conduct in vitro experiments. The scope of the daily responsibilities for this position includes, but is not limited to, developing bioanalytical methods, quantitating drug candidates and their metabolites, endogenous biomarkers in biological matrices (e.g. blood, plasma, tissue, tumor, CSF, etc.), reporting bioanalytical results and managing projects outsourced in CROs to support all in vitro and in vivo studies. The successful candidate will have extensive experience in bioanalytical method development and sample analysis using LC-MS/MS and other analytical techniques.

**Responsibilities**

- Provide bioanalytical support for in-house PK, non-GLP safety TK
- Conduct bioanalytical method development and qualification to support drug, metabolite and biomarker analysis
- **Independently develop LC-MS/MS methods to quantitate small molecules in in vitro and in vivo samples**
- Conduct in-vitro stability assays to understand metabolism of drugs
- Perform metabolic identification (MetID) using LC-QTOF MS/MS, including accurate mass analysis, fragment interpretation and biotransformation pathway assignment
- Independently operate, troubleshoot and maintain LC-MS/MS systems
- Participate in multidisciplinary project teams and collaborate with other departments to understand bioanalytical needs for both PK and PD support
- Manage projects conducted at CROs to ensure high quality bioanalytical data is delivered to meet project timelines
- Maintain accurate and detailed scientific electronic laboratory notebooks
- Perform all duties in keeping with the Company’s core values, policies and all applicable regulations

**Preferred Qualifications & Experience**

- Experience with H/UPLC and mass spectrometry
- Good working knowledge of SCIEX LC-MS/MS systems for small molecule quantitation
- PK analysis using Phoenix or other data management software
- Management experience with CROs for outsourcing BA activities is preferred
- Provide sample analysis to support PK, PK/PD, PK/efficacy, distribution, metabolism, and non-GLP toxicology studies
- Identify issues and troubleshoot scientific equipment including LC-MS/MS, select and develop appropriate methods to perform experiments, analyze data and prepare related reports.
- Excellent oral and written communication skills

**Minimum Requirements**

- BS or master’s with 4 years’ experience working in a discovery setting using LC-MS/MS within a pharmaceutical/biotechnology company
- Broad experience in small molecule drug candidate bioanalytical assay development/sample analysis in different biological matrices using LC-MS/MS
- Experience with AB SCIEX mass spectrometry software
- Excellent written, verbal communications and interpersonal skills to collaborate with internal and external partners in a matrix environment

**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

**Location** Brisbane, CA - Onsite

**Salary Range** 93K - 107K

Syner-G BioPharma Group

Consultant II, Regulatory Affairs Advertising and Promotion

**COMPANY DESCRIPTION:**

A career here is life-enhancing.

At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video [**here**](<https://www.youtube.com/watch?v=2rUMvtncuw8>).

Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner.

Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation.

At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.

For more information, visit [www.Synergbiopharma.com](<https://www.synergbiopharma.com/>)

**POSITION OVERVIEW:**

This role is responsible for ensuring promotional communications are truthful, balanced, non-misleading, evidence-based, and consistent with approved product labeling, applicable FDA requirements, OPDP expectations, Health Canada regulations, and PAAB Code standards. The Consultant II serves as a key regulatory partner to Commercial, Medical, Legal, and Global Regulatory teams, enabling timely and compliant execution of brand strategy across product launch and lifecycle activities.

The position leads regulatory review and risk assessment activities for US and Canadian promotional materials directed to healthcare professionals, payers, patients, and other external stakeholders across traditional, digital, and omnichannel platforms. Success in this role requires strong regulatory expertise, sound judgment, and the ability to translate complex regulatory requirements into practical business guidance.

**WORK LOCATION:**

Travel to client sites may be required up to 10%, based on project demands and client expectations.

**KEY RESPONSIBILITIES:**

(This list is not exhaustive and may be supplemented and changed as necessary.)

- Oversee the preparation and submission of regulatory documents.
- Lead regulatory review and approval of US and Canadian promotional, advertising, disease awareness, training, congress, payer, market access, patient support, corporate communication, and digital materials for assigned products.
- Evaluate materials for consistency with approved labeling, scientific evidence, fair balance requirements, risk communication, comparative claims, appropriate audience targeting, and overall regulatory compliance.
- Conduct risk assessments and provide recommendations that support compliant and effective stakeholder communications.
- Ensure promotional communications are supported by appropriate evidence and aligned with applicable regulatory and industry standards.
- Serve as the Regulatory Affairs representative on promotional review committees.
- Collaborate with Medical Affairs, Legal, Commercial, Market Access, Corporate Affairs, Pharmacovigilance, and Compliance partners to facilitate timely review and approval of materials.
- Partner with internal stakeholders and external agencies to resolve regulatory comments and ensure alignment on promotional strategy.
- Represent Regulatory Affairs in interactions with alliance partners and global teams.
- Provide strategic guidance regarding FDA and OPDP requirements for prescription drug advertising, promotional labeling, product claims, risk communication, and submission readiness.
- Advise teams on Health Canada advertising requirements, PAAB standards, and Canadian promotional review expectations.
- Support promotional strategy for product launches, lifecycle management activities, label changes, and new indications.
- Provide guidance on claim development, evidence generation strategies, competitive positioning, and use of clinical, real-world, and health economic evidence in promotional materials.
- Support PAAB submissions, responses, and approval strategies for Canadian promotional materials.
- Collaborate with internal stakeholders and external agencies to address PAAB feedback, develop supporting references, revise claims, and achieve timely approvals.
- Ensure healthcare professional-directed materials meet PAAB preclearance requirements and industry standards.
- Monitor FDA, OPDP, Health Canada, PAAB, and industry developments, including enforcement trends, guidance updates, and evolving regulatory expectations.
- Communicate regulatory changes and business implications to key stakeholders.
- Develop and deliver training programs, job aids, and best practices to strengthen promotional compliance and review quality.
- Support continuous improvement initiatives related to review workflows, documentation standards, governance processes, escalation pathways, and inspection/audit readiness.

**QUALIFICATIONS AND REQUIREMENTS:**

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, skills, knowledge, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

*Education*

- Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related discipline required.
- Advanced degree preferred.

*Technical Experience*:

- Minimum 3-5 years of experience within the pharmaceutical, biotechnology, biologics, biosimilars, regulatory, or health authority environment.
- Significant experience in advertising and promotional regulatory review.
- Experience participating in multidisciplinary Medical/Legal/Regulatory (MLR) review processes.
- Demonstrated ability to influence cross-functional teams while maintaining regulatory integrity.

*Knowledge, Skills, and Abilities*:

- Strong knowledge of FDA promotional requirements and OPDP expectations governing prescription drug advertising and promotional labeling.
- Strong understanding of Health Canada advertising requirements, PAAB Code standards, and the Canadian preclearance process.
- Ability to evaluate clinical evidence, product labeling, safety information, comparative claims, real-world evidence, and market access messaging for promotional compliance.
- Knowledge of fair balance principles, risk communication requirements, claim substantiation, and evidence-based promotional practices.
- Strong project management, prioritization, and decision-making capabilities.
- Excellent written and verbal communication skills with the ability to provide practical, solution-oriented regulatory guidance to senior stakeholders.

*Preferred Qualifications*

- Experience supporting both US and Canadian promotional review activities for prescription drugs, biologics, or biosimilars.
- Direct experience with OPDP advisory submissions, FDA promotional correspondence, PAAB submissions, and Canadian preclearance review processes.
- Experience supporting product launches, new indications, label updates, digital campaigns, congress materials, omnichannel initiatives, and competitive response strategies.
- Familiarity with electronic promotional review systems, document management platforms, reference management tools, and audit-ready documentation practices.
- Experience mentoring or providing guidance to junior regulatory professionals.

**ESSENTIAL FUNCTIONS:**

*Physical Demands*:

The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus.

*Work Environment*:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment.

**TOTAL REWARDS PROGRAM:**

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere.” However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.

Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time.

**LEGAL STATEMENT:**

Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.

Nationwide

AbbVie

Archive Records Analyst

Company Description

**About AbbVie**

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at [www.abbvie.com](<http://www.abbvie.com/>). Follow @abbvie on [LinkedIn,](<https://www.linkedin.com/company/abbvie/>) [Facebook](<https://www.facebook.com/AbbVieGlobal/>), [Instagram](<https://www.instagram.com/abbvie/>), [X](<https://twitter.com/abbvie>) and [YouTube.](<https://www.youtube.com/user/AbbVie>)

Job Description

**Purpose:**

The Archive Records Analyst provides leadership for high-priority, complex initiatives supporting the records management electronic archiving program. This department archives records from across the company, including business and GxP regulated records such as Pre-Clinical, Clinical, Regulatory and Safety.

This position is a key member of the Electronic Records Archiving Center of Practice, with responsibility for supporting the global deployment of the records lifecycle governance and applications. This position reports to the AbbVie Archive Senior Manager/Manager.

**Responsibilities**

- Assumes a leadership role in driving records management enterprise governance

- Contributes to program performance including implementation of activities per the records strategy

- Key interface with global records management teams

- Monitor and report on global deployment project plans / deliverables as required for management

- Provide program status updates as required against milestones to management and business stakeholders

- Ability to work with archiving IT system(s) and team(s)

- Can create and effectively deliver communication plans and communications that are:

- Clear and concise

- Across management levels

- Targeted for a country, region or global audience

- Must have excellent partnering skills to facilitate projects within and across organizations

- Accountable for providing input and managing within budgetary requirements

- Responsible for compliance with applicable policies and procedures

- Perform other duties as assigned

Qualifications

**Qualifications**

- Required Education:
- Associate, Bachelor's degree or equivalent with 5 years minimum related
  experience OR High School diploma or equivalent and 7 years related experience ;
  Related certifications a plus
- 5+ years related experience in a regulated industry such as, pharmaceutical, medical device manufacturing, regulatory affairs or quality
- 5+ years of experience in records management and/or working in an archive
- Knowledge and hands on experience with a Document and/or Records Management System
- Experience working in a complex, matrixed environment
- Robust communication skills, both oral and written
- Advanced knowledge and experience with MS Excel, Word, PowerPoint, and SharePoint
- Preferred Experience:
- Experience with global teams and/or deployments
- Experience working with IT systems

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit [https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html](<https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html>)

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

[https://www.abbvie.com/join-us/reasonable-accommodations.html](<https://www.abbvie.com/join-us/reasonable-accommodations.html>)

Illinois

Ocugen, Inc.

Associate Director, Program Management

Description

**Position Summary**

The Associate Director (AD) partners with cross-functional project leads to drive programs from concept through commercialization. This role ensures cohesive execution across R&D, CMC, regulatory and commercial functions—delivering on time, within budget, and to quality standards.

This role provides strategic and operational leadership, proactively identifies and mitigates risks, and ensures clear communication and accountability across teams. The position also serves as an independent voice in shaping program strategies and updating senior leadership on progress, risks, and portfolio impact.

**Responsibilities**

- Partner with the Development Program Lead (DPL) to foster a high performing team and monitor the health and operating efficiency of the team as a unit.
- Lead creation of team norms and operating principles with a focus on cross-functional input and accountability, and robust analysis of vetted options.
- Act as an integrator within the Development Program Team (DPT) and across the enterprise to ensure alignment and connect best practices.
- Facilitate effective, science-based business decisions including development of scenarios as Ensures all decisions are assessed as to their impacts and communicated to stakeholders in a transparent and timely manner.
- Highlight interdependencies and downstream impacts of strategic decisions.
- Proactively identify risks and ensure mitigation plans are implemented.
- Develop and coordinate resource planning across DPT to ensure adequate resources are applied to the project.
- Advise on governance expectations with focus on cross-functional input and rigorous debate.
- Coach project team members and others to drive excellence and accountability and develop talent pipeline for DPT membership.
- Change Agent for continuous improvement and transformational initiatives.
- For projects that are being jointly developed, work closely with a key strategic alliance partner
- Identify and mitigate project risks during the various phases of development of Drug and communicate risks to relevant stakeholders.
- Collaborate with external CDMO, CRO, to define project timelines, establish and monitor KPIs, and manage relationships.
- Ensure that the non-clinical studies are performed as per the quality requirements of GXP.
- Facilitate effective, science-based business decisions including scenarios analysis and identification of critical path tasks
- Define budget and resource needs, create work breakdown structures, set and track deliverables, perform critical path analysis.
- Ensure program communication and report program status to team and Senior Leadership on regular basis.
- Recommend and implement best practices across program teams g., resource capacity planning, program risk management, team performance, timeline development, portfolio management.
- Work with functional leaders to ensure positive team spirit and high functioning team.
- Prepare monthly progress reports and ad hoc reports as required.
- Participate in development of Program Management tools, templates and processes. Additional tasks and projects as requested.

Qualifications

- Bachelor’s degree in a science discipline or related field is required and preferably Ph.D.
- 10+ years of relevant pharmaceutical industry experience, with at least 2 years managing multi-functional project teams.
- Breadth of drug development expertise with solid understanding of project strategy and disease content to contribute to strategic discussions.
- Experience in pharmaceutical drug discovery and development.
- Knowledge of manufacturing and CMC changes.
- Possesses knowledge of all phases of the drug development cycle and has technical understanding toward the successful development and registration of pharmaceutical products.
- Fully trained in all relevant PM processes and can competently use and employ essential project management tools and methodologies to facilitate project team activities, manage risks and ensure team execution.
- Ability to resolve complex problems and manage difficult stakeholder situations.
- Ability to lead the development of critical path analyses and support scenario planning.
- Excellent Project Management Skills – drives execution while balancing speed, quality, and PMP certification desirable.
- Demonstrated ability to think strategically, work effectively in a matrixed environment, and execute multiple projects simultaneously.
- Advanced working knowledge of MS Project or Smartsheets, Excel, OneNote, and PowerPoint.
- High level of personal integrity and strong conflict resolution and consensus building skills.
- Ability to work effectively with cross-functional teams.

**Working Conditions**

This position operates in an office setting, in person. Job may additionally require incumbent to be available outside of these hours to handle priority business needs.

*Ocugen is an equal opportunity employer. In order to provide equal employment and advancement opportunities to all individuals, we make all of our employment decisions based upon merit, qualifications, abilities, and an individual’s conduct and performance. We will not make any of our decisions, and will not discriminate against any employee or applicant, on the basis of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including sexual orientation, gender identity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, or any other characteristic protected from discrimination under the law. Ocugen complies with applicable federal, state and local laws governing nondiscrimination in employment.*