Information Technology

AbbVie

Data Science Program Lead II

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

The Clinical Data Strategy and Operations (CDSO) DMO Lead or Clinical Data Scientist (CDS) serves as the data management domain expert and key strategic partner to the clinical study team. This role owns the data collection strategy, drives implementation, oversees data quality delivery, and supports on-time achievement of key study milestones. As the Data Operations single point of contact for cross-functional stakeholders, the DMO Lead or CDS applies strong project management, risk oversight, and continuous process optimization to enable data quality, inspection readiness, and successful trial delivery.

Responsibilities:

- Serves as the CDSO data management subject matter expert and single point of contact for assigned studies, owning data collection, data cleaning, and database lock strategies to enable high-quality, inspection-ready study delivery.
- Leads risk-based and continuous data review strategies from study start-up through database lock, leveraging centralized monitoring, statistical review, and clinical data science methodologies to proactively identify and mitigate study risks.
- Triages data quality standards across studies to identify trends, drive site-level actions through effective cross-functional communication, and maintain data currency in support of timely, reliable study decisions.
- Interprets clinical and operational data, quality metrics, predictive signals, and dashboard outputs to develop data-driven recommendations that strengthen study execution, risk management, patient safety oversight, and quality across the clinical development lifecycle.
- Contributes to defining, managing, and monitoring data-driven protocol deviations.
- Defines and manages study data flow and triages issues from raw EDC data through mapped SDTM data, partnering with internal technology teams, service providers, and vendors to drive timely mitigation and support end-to-end data integrity.
- Performs data mining and custom analytics, gathers business requirements for study dashboards, and generates operational metrics that support study decisions.
- Ensures adherence to federal and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie SOPs, and functional quality standards; stays abreast of evolving guidance.
- Influences cross-functional stakeholders without direct authority, aligning clinical, statistical, medical, safety, regulatory, technology, and vendor organizations around data-driven decisions and clinical data science strategies.
- Leads CDSO innovation and process improvement initiatives and participates in cross-functional efforts that improve operational effectiveness, scalability, and study delivery quality.
- Coaches and mentors team members.

Qualifications

- Bachelor’s degree in business, management information systems, computer science, life sciences or equivalent. Masters preferred.
- Must have 6+ years of pharma / clinical research / data management / health care experience or 8+ years of project management experience (and / or applicable work experience).
- In-depth understanding of clinical trial processes and clinical technology. Management of a clinical trial from initiation through to completion in a lead role is preferred.
- Demonstrated performance as a functional leader
- Demonstrated ability to influence others without direct authority
- Demonstrated ability to successfully coach / mentor in a matrix environment
- Demonstrated effective communication skills
- Demonstrated effective analytical skills

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 long-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>)

California

Insmed Incorporated

Director, Commercial Analytics

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

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

**About the Role:**

We're looking for a Director, Commercial Analytics on the Commercial Effectiveness team to help us expand what's possible for patients with serious diseases. Reporting to the Senior Director, Commercial Analytics, you'll be responsible for delivering analytically rigorous, high-impact insights that accelerate the growth of Insmed's approved Respiratory portfolio asset while advancing strategies to expand disease diagnosis and patient identification.

This role partners closely with Commercial Strategy, Marketing, Medical, and Market Access to transform complex healthcare data into actionable insights that optimize brand strategy and commercial performance. You'll also quantify diagnostic opportunities, identify the key drivers of diagnosis expansion, and evaluate the effectiveness of initiatives designed to accelerate patient identification and movement across the diagnostic journey.

The ideal candidate combines deep expertise in healthcare data, advanced analytics with strong commercial acumen and a disciplined, hypothesis-driven approach to translating data into strategic business decisions.

This is a hands-on leadership role that requires an entrepreneurial mindset and a willingness to execute every stage of the analytics lifecycle - from data acquisition and transformation through advanced analytics, insight generation, and compelling storytelling - to influence strategic decisions and drive business impact.

**What You'll Do:**

In this role, you'll have the opportunity to lead high-impact analytics initiatives across both commercial execution and diagnosis expansion, driving growth of Insmed's Respiratory portfolio asset, while helping more patients get diagnosed and treated. You'll also:

- Partner with Commercial Strategy, Marketing, Medical, and Market Access to generate actionable insights that inform brand strategy and drive commercial growth
- Monitor brand performance, competitive dynamics, and market trends to proactively identify growth opportunities and business risks
- Measure commercial effectiveness, promotional ROI, and market dynamics to optimize resource allocation and business performance
- Quantify diagnostic opportunities and identify actionable levers to accelerate patient identification and disease diagnosis
- Evaluate the effectiveness of diagnosis expansion initiatives and recommend strategies to improve performance across the patient journey
- Leverage real-world data and advanced analytics to inform disease awareness, patient finding, and diagnosis expansion strategies
- Lead the design and execution of advanced analytics, predictive models, and commercial effectiveness initiatives to support strategic decision-making
- Translate complex analyses into clear, compelling recommendations that influence senior leadership and cross-functional stakeholders
- Identify opportunities to leverage AI, machine learning, and innovative data sources to enhance commercial and diagnosis expansion strategies
- Foster a culture of analytical excellence, collaboration, and continuous improvement across cross-functional teams

**Who You Are:**

You have a Bachelor's degree in Data Science, Health Economics, Statistics, Marketing Analytics, or a related quantitative field, along with 10+ years of commercial experience in the pharma/biotech industry (or equivalent). An MBA or advanced degree (MS, PhD) is preferred. Rare disease, specialty, or respiratory experience is a plus.

You will also have:

- Extensive knowledge of pharmaceutical data (e.g., sales, specialty pharmacy, payer, promotional & marketing data, longitudinal patient-level data)
- Deep expertise with APLD and real-world data (claims, EMR, patient-level)
- Strong understanding of patient journey, treatment flow analyses, disease epidemiology
- Demonstrated experience working with cross-functional teams and influencing senior-level stakeholders
- Excellent communication skills with the ability to translate analytics into clear, actionable commercial recommendations
- Proven ability to work with distributed teams in a matrix environment, as well as autonomously
- Technical proficiency in analytics tools (SQL, Python, R, SAS, or similar platforms)
- Inquisitive nature with the ability to dig deeper into data and trends, synthesizing findings into a clear and concise story
- Highly organized with strong attention to detail, clarity, accuracy, and conciseness
- Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook)

**Where You’ll Work**

This is a hybrid role based out of our Bridgewater NJ office. You’ll have the option to work remotely most of the time, with in-person collaboration when it matters most

**Travel Requirements**

This role requires occasional travel (approximately 20%)

\#LI-TB1

\#LI-Hybrid

**Pay Range:**

$177,000.00-242,000.00 Annual

**Life at Insmed**

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

Highlights of our U.S. offerings include:

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

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

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

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

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

[*TotalRewards@insmed.com*](<mailto:TotalRewards@insmed.com>) *and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.*

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

New Jersey

Senior Director, Regulatory Affairs - Early Development/Business Development

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

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

**About the Role:**

We’re looking for a Senior Director, Regulatory Affairs – Early Development/ Business Development on the Regulatory Affairs team to help us expand what’s possible for patients with serious diseases. Reporting to the Senior Vice President, Regulatory Affairs, you’ll provide strategic and operational regulatory leadership to support both early-stage drug development and business development programs. Responsibilities will include strategic evaluation of regulatory risks and opportunities for external assets, assessing likelihood of technical and regulatory success, and contributing to the development and execution of global regulatory strategies for internal pipeline programs. You will work cross-functionally to enable informed investment decisions and contribute to the efficient advancement of development programs by developing the regulatory strategy for selected drug candidates. You will provide regulatory input to global cross-functional project teams throughout the phases of product development and related submission activities and will serve as the global or regional regulatory lead on the projects. You will act as the primary regulatory contact for the US FDA.

**What You'll Do:**

In this role, you’ll have the opportunity to develop and lead the regulatory strategy for early development programs. Additionally, you will represent the regulatory affairs department on due diligence assessments for external assets, including evaluation of regulatory pathways, data packages, risks, and mitigation strategies. You’ll also:

- Critically assess completeness and adequacy of nonclinical, clinical, and CMC data packages, identifying key gaps, risks, and value inflection points
- Provide clear regulatory recommendations to support early development/business development decisions and participate in senior leadership discussions
- Contribute to cross-functional diligence teams, integrating regulatory perspectives into overall asset valuation and development planning
- Contribute to preparation and submission of regulatory documents (e.g., pre-IND meeting requests, briefing books, INDs, amendments)
- Support health authority interactions, including meeting strategy, briefing materials, and response development
- Provide regulatory input into study design, endpoints, and overall development plans and ensure alignment of regulatory strategy with clinical, nonclinical, and CMC plans
- Partner cross-functionally with Clinical, CMC, Nonclinical, Biostatistics, and Program Management teams
- Monitor evolving regulatory landscape and apply relevant guidance and precedents and identify regulatory risks proactively and propose practical mitigation strategies
- Ensure high-quality and timely delivery of regulatory contributions across programs

**Who You Are:**

You have an advanced degree (PhD, PharmD, MS) along with 10+ years of experience in Regulatory Affairs or related functions, with hands-on experience in regulatory submissions across multiple regions (U.S., EU, and/or other international markets). You also have:

- Experience supporting early-stage drug development (pre-IND through Phase 2)
- Demonstrated experience contributing to regulatory submissions and health authority interactions (e.g., pre-IND, Type B meetings)
- Strong understanding of global regulatory frameworks
- Deep understanding of the drug development process
- Ability to critically assess scientific, clinical, and CMC data in a regulatory context
- Strong communication, strategic thinking, and cross-functional collaboration skills
- Ability to manage multiple priorities in a fast-paced environment
- Highly organized with strong attention to detail, accuracy, clarity, and conciseness
- Ability to manage tight deadlines; must be efficient, detail-oriented, adaptable, and a self-starter

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

- Experience in regulatory due diligence, business development, or asset evaluation preferred
- Strong understanding of global regulatory frameworks (FDA, EMA; PMDA a plus)

**Where You’ll Work**

This is a fully remote role. It can be performed effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events will be expected.

**Travel Requirements**

This role requires occasional domestic/international/global travel (approximately 20%)

\#LI-REMOTE

\#LI- JK

**Pay Range:**

$222,000.00-303,000.00 Annual

**Life at Insmed**

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

Highlights of our U.S. offerings include:

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

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

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

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

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

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

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

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

Nationwide

Senior Manager, Human Resources Business Partner (P)

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

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

**About the Role:**

In this role, the Senior Manager, HR Business Partner will develop and grow meaningful relationships with employees and people leaders within assigned R &D functions. This individual will contribute to key areas including talent management and development, change management, workforce planning, organization development, performance management, and employee relations. This is a wonderful opportunity for an HR professional looking to deepen their business partnership skills in a collaborative, mission-driven environment.

**What You'll Do:**

In this role you will build trusted relationships with employees and managers across assigned functions, serving as an accessible and reliable HR resource; participate in business discussions to understand team needs and contribute thoughtful recommendations.

You will also:

- Support the implementation of HR policies and procedures that help develop, engage, and retain employees; assist with change management efforts and organizational adaptation.
- Participate in the talent evaluation process during hiring, gaining exposure to full-cycle recruitment partnership.
- Support the development and communication of HR programs — such as year-end performance alignment sessions, talent planning discussions, employee development conversations, in collaboration with the broader HR team.
- Identify and support client engagement opportunities and training programs.
- Support a culture of innovation through the adoption of AI-driven tools, continuously evolving practices to reflect emerging trends and best-in-class standards.
- Support strategic communications related to benefits, compensation, and other HR programs and initiatives.
- Assist people leaders in navigating employee relations matters, learning to balance employee accountability with organizational needs in a fair and consistent manner.
- Support the investigation and resolution of Employee Relations issues.
- Partner with internal HR Centers of Excellence to support the delivery of organization-wide programs and the onboarding of new employees.
- Leverage people data and analytics to inform recommendations and support HR initiatives and programs.

**Who You Are:**

You have a Bachelor's degree in a related discipline, Master's degree a plus. Additionally you have a minimum of 6 years of HR and related experience

You also have:

- 3+ years of experience in the biotech/pharma sector required; exposure to R&D functions is a plus
- Experience working in a fast-paced, evolving environment with a demonstrated ability to adapt and grow
- Working knowledge of local, state, and federal employment law; commitment to continued learning in this area
- PHR certification preferred or active pursuit of HR certification encouraged
- Strong interpersonal skills with a genuine interest in building trusted, collaborative relationships
- Demonstrated ability to handle confidential information with discretion
- Solid reasoning, problem-solving, and conflict resolution skills, with a willingness to seek guidance when needed
- Developing project management skills with a strong attention to detail
- Strong collaboration and teamwork orientation
- Excellent verbal and written communication skills
- Highly organized with a focus on clarity, accuracy, and follow-through
- Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook)

**Travel Requirements**

This role requires occasional domestic travel approximately \<10%

**Where You’ll Work**

This is a hybrid role based out of ourBridgewater, NJ Headquarters.You’llwork remotely most of the time, with in-person collaboration when it matters most.

\#LI-SK1

\#LI-SK - Hybrid

**Pay Range:**

$124,000.00-161,000.00 Annual

**Life at Insmed**

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

Highlights of our U.S. offerings include:

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

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

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

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

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

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

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

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

Associate Director-Small Molecule, Analytical Development

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

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

**About the Role:**

We’re looking for an Associate Director, Analytical Development, Small Molecule on the Analytical Development team to help us expand what’s possible for patients with serious diseases. Reporting to the Director, Analytical Development, you’ll be responsible for leading and overseeing analytical development activities for small molecule drug substance and drug product programs across multiple dosage forms, including but not limited to oral solid, oral liquid, inhalation, and other specialized formulations. This role will provide strategic and technical leadership for analytical method development, qualification, validation, troubleshooting, and transfer activities to support product development from early-stage research through commercialization.

**What You'll Do:**

In this role, you’ll have the opportunity to lead analytical development activities for small molecule drug substance and drug product programs across multiple dosage forms, including oral solid, oral liquid, inhalation, and other emerging technologies. You’ll also:

- Develop and implement analytical strategies to support product development from preclinical and clinical stages through commercialization.
- Provide technical leadership for analytical method development, optimization, qualification, validation, verification, and lifecycle management in accordance with ICH, FDA, EMA, and other global regulatory expectations.
- Manage external analytical laboratories, CROs, CDMOs, and testing partners to ensure timely execution of analytical development activities, method transfers, validation studies, and stability testing.
- Review and approve analytical protocols, reports, method validation documents, specifications, development reports, and technology transfer packages.
- Provide analytical expertise and cross-functional support for nitrosamine and mutagenic impurity assessments, including strategy development, analytical testing, and regulatory support.
- Serve as the analytical subject matter expert for characterization of drug substances, intermediates, excipients, and drug products, including impurity profiling, degradation pathways, extractables and leachables assessments, and stability-indicating methodologies.
- Support formulation and process development activities through analytical troubleshooting, root cause investigations, and data-driven recommendations.
- Lead analytical method transfer activities between development, manufacturing, and external testing laboratories to ensure successful execution and regulatory compliance.
- Establish scientifically justified specifications and acceptance criteria for raw materials, drug substances, intermediates, and finished products throughout the product lifecycle.
- Author, review, and provide analytical content for regulatory submissions, including INDs, IMPDs, NDAs, MAAs, and other global filings. Support responses to regulatory agency questions and inspections.
- Collaborate closely with Pharmaceutical Development, Quality Assurance, Regulatory Affairs, Supply Chain, Manufacturing, and Project Management teams to achieve program objectives and development timelines.
- Ensure analytical activities are conducted in compliance with cGxP, ICH guidelines, USP/EP/JP requirements, and applicable regulatory standards.
- Evaluate emerging analytical technologies and industry best practices to drive continuous improvement, operational efficiency, and scientific innovation.
- Manage multiple analytical development programs simultaneously, identify technical and timeline risks, and develop effective mitigation strategies.
- Interpret complex analytical data, provide scientific leadership for problem-solving efforts, and contribute to overall CMC strategy and product development decisions.

**Who You Are:**

You have a Bachelor’s degree along with 10 years of experience in specifically analytical development with at least 5 years roles involving oversight of external testing laboratories. You are or you also have:

- Bachelor's degree in Chemistry, Biochemistry, or related discipline with 8+ years of experience in the pharmaceutical industry, specifically analytical development with at least 5 years roles involving oversight of external testing laboratories.
- Hands-on expertise in analytical lab testing for inhalation dosage forms and other small molecule dosage forms. Experience with inhalation and combination products is preferred.
- Strong knowledge and experience in nitrosamine risk assessment, including identification, evaluation, and control of nitrosamine impurities.
- Experience with mutagenic impurity assessment, including evaluation of potential genotoxic impurities and application of relevant regulatory guidance.
- Proficient in regulatory requirements, including cGxP, CMC, ICH, and compendial standards (USP/EP/JP).
- Excellent analytical and problem-solving skills, particularly in the context of technical troubleshooting and investigation management.
- Effective communication skills, both verbal and written, including experience drafting regulatory responses and QC sections of submissions.
- Strong organizational and project management skills, with a focus on timeliness, quality, and compliance.
- Must embody the core values of Collaboration, Accountability, Passion, Respect, and Integrity, and demonstrate the ability to work in a diverse, dynamic environment. Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.

**Where You’ll Work**

This role is based out of our Bridgewater, NJ office and requires full-time, in-person presence to support hands-on collaboration, access specialized equipment, and/or operational needs.

**Travel Requirements**

Minimal travel expected

\#LI-BA

\#LI-ONSITE

**Pay Range:**

$155,000.00-201,500.00 Annual

**Life at Insmed**

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

Highlights of our U.S. offerings include:

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

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

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

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

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

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

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

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

Scientist, Analytical Development, Small Molecule

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

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

**About the Role:**

We’re looking for a Scientist, Analytical Development, Small Molecule on the Analytical Development team to help us expand what’s possible for patients with serious diseases. Reporting to the Director, Analytical Development, you’ll support analytical method development and contribute to the testing of small molecule candidates. While experience with inhalation products is a plus, the core responsibilities will include maintaining compliance with regulatory requirements, ensuring data integrity, and collaborating with cross-functional teams to meet project goals. A deep understanding of GMP, quality control processes, and the pharmaceutical development lifecycle is essential for this position.

**What You'll Do:**

In this role, you’ll have the opportunity to take the responsibility for small molecule products analytical routine testing (inhalation combination products, tablet formulations, and oral solutions) from early-stage development through to Phase III and commercialization. You’ll also:

- Ensure all testing is performed in compliance with GMP regulations and internal standard operating procedures (SOPs).
- Accurately recording and reporting test results, maintaining detailed and compliant documentation in accordance with GMP.
- Validate analytical methods using advanced techniques (e.g., HPLC, UPLC, GC, XRPD, Raman, PSD, FTIR, Dissolution and more) to support drug substance and drug product characterization.
- Work closely with formulation scientists, process development teams, and regulatory groups to support CMC activities, ensuring analytical methods meet the necessary regulatory standards.
- Lead pre-formulation and stability studies for small molecule drug products to assess their shelf life and ensure product quality during development and commercialization.
- Analyze complex data, identify potential issues in analytical methods or product quality, and propose scientifically sound solutions to overcome technical challenges.
- Prepare technical documents such as protocols, development reports, validation reports, and regulatory submissions, ensuring they are compliant with cGMP and regulatory requirements.
- Contribute to regulatory filings (IND, NDA), including providing the necessary analytical data and documentation required for submissions to global health authorities.
- Ensure all analytical activities comply with cGxP, ICH guidelines, and regulatory standards for the pharmaceutical industry, including USP/EP/JP requirements.
- Interpret complex data to solve challenging problems and provide scientific direction within the AR&D laboratory.

**Who You Are:**

You have a Bachelor’s degree along with five years of experience in Chemistry. You are or you also have:

- Hands-on expertise in analytical lab testing for inhalation dosage forms, solid oral and liquid dosage forms. Experience with inhalation and combination products is preferred.
- Proficient in regulatory requirements, including cGxP, CMC, ICH, and compendial standards (USP/EP/JP).
- Ability to conduct risk assessments and develop analytical methods for the detection and control of nitrosamine impurities, ensuring compliance with regulatory guidelines.
- Strong commitment to laboratory work with meticulous attention to detail.
- Advanced proficiency in Microsoft Office tools.
- Excited to contribute to a fast-paced, team-oriented environment focused on accelerating early-stage drug development.
- Must embody the core values of Collaboration, Accountability, Passion, Respect, and Integrity, and demonstrate the ability to work in a diverse, dynamic environment. Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.

**Where You’ll Work**

This role is based out of our Bridgewater, NJ office and requires full-time, in-person presence to support hands-on collaboration, access specialized equipment, and/or operational needs.

**Travel Requirements**

Minimal travel expected

\#LI-BA

\#LI-ONSITE

**Pay Range:**

$103,000.00-131,000.00 Annual

**Life at Insmed**

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

Highlights of our U.S. offerings include:

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

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

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

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

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

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

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

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

Senior Scientist, Analytical Development - Small Molecule

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

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

**About the Role:**

We’re looking for a Senior Scientist, Analytical Development on the Analytical Development team to help us expand what’s possible for patients with serious diseases. Reporting to the Associate Director, Analytical Development, you’ll lead analytical development efforts for small-molecule drug substances and drug products. This role will support early- to late-stage development programs and ensure robust characterization, method development, and regulatory compliance to advance our pipeline toward clinical and commercial success.

**What You'll Do:**

In this role, you’ll have the opportunity to lead the development and optimization of analytical methods for starting materials, intermediates, drug substances, and drug products. You’ll also:

- Utilize a wide range of analytical techniques, including HPLC, GC, LC-MS, NMR, UV, and FTIR, to ensure method suitability for intended applications.
- Design and lead method validation activities to ensure compliance with ICH, FDA, EMA, and other applicable regulatory guidelines.
- Oversee method development and transfer activities to manufacturing or quality laboratories, ensuring clear documentation and effective technology transfer.
- Prepare, review, and approve technical documents, including standard operating procedures (SOPs), analytical methods, protocols, reports, and product specifications.
- Author and review analytical sections of regulatory submissions (IND, IMPD, NDA/MAA) and support regulatory interactions as an analytical subject matter expert.
- Collaborate with process chemistry, development teams, quality assurance, and regulatory affairs to ensure analytical needs are met across the product lifecycle.
- Lead or contribute to cross-functional project teams, manage analytical development timelines, and communicate progress to stakeholders.
- Serve as the Analytical Lead for CMC programs, overseeing analytical deliverables, including method development, validation, and GMP testing for both internal teams and external partners.
- Manage and oversee external service providers supporting analytical development activities, ensuring timely deliverables and continuous process improvements.
- Provide technical troubleshooting, data interpretation, and review of analytical data, including method validation documents, Certificates of Analysis (CoAs), and stability reports.
- Lead the design and development of phase-appropriate quality control strategies, specifications, and stability programs for drug substances and drug products.
- Contribute to CMC operations, including execution, process improvements, and development of operational capabilities.
- Collaborate with cross-functional teams across the organization to establish and enhance technical and business practices.
- Perform additional responsibilities as assigned to support evolving departmental needs.

**Who You Are:**

You have a bachelor’s degree in chemistry, Biochemistry, or related discipline with 6+ years of experience, or master’s degree with 4+ years of experience.

You are or you also have:

- Hands-on expertise in analytical lab testing for inhalation dosage forms, solid oral and liquid dosage forms. Experience with inhalation and combination products is preferred.
- Proficient in regulatory requirements, including cGxP, CMC, ICH, and compendial standards (USP/EP/JP).
- Strong commitment to laboratory work with meticulous attention to detail.
- Advanced proficiency in Microsoft Office tools.
- Must embody the core values of Collaboration, Accountability, Passion, Respect, and Integrity, and demonstrate the ability to work in a diverse, dynamic environment. Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.

**Where You’ll Work**

This role is based out of our Bridgewater, NJ office and requires full-time, in-person presence to support hands-on collaboration, access specialized equipment, and/or operational needs.

**Travel Requirements**

Minimal travel expected

\#LI-BA

\#LI-ONSITE

**Pay Range:**

$127,000.00-165,500.00 Annual

**Life at Insmed**

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

Highlights of our U.S. offerings include:

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

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

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

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

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

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

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

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

Manager, Product Quality Complaint Data Analytics

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

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

**About the Role:**

The Manager, Product Quality Complaint Data Analytics, reports to the Director of Product Quality Complaints and is responsible for leading the governance, analytics, reporting, system support, and continuous improvement of Insmed's global Product Quality Complaint program. This role serves as the business and technical subject matter expert for complaint analytics, reporting, Veeva system enhancements, process improvements, and complaint surveillance.

The position is accountable for developing and maintaining the analytical framework used to identify product quality trends, evaluate complaint data, and support Management Review and executive decision-making. The Manager partners with Product Quality Complaints, QA Operations, Technical Operations, DSPV, Quality Systems, and Patient Services to support product quality investigations, implement system enhancements, and drive continuous process improvements.

The position will be based in Bridgewater, NJ HQ (onsite 3 days a week).

**What You'll Do:**

In this role, you’ll have the opportunity to lead the Product Quality Complaint Analytics function, including complaint analytics, reporting, metrics, trending, Veeva system support and enhancements, process improvements, and Management Review reporting.

You’ll also:

- Lead and manage the QA Sr Product Complaint Specialist, providing technical leadership, coaching, performance management, and professional development to direct reports. Establish team priorities, manage workload, allocate resources, and ensure timely completion of metrics activities and assigned projects.
- Support new product launch, and continuous improvement of Insmed's Product Quality Complaint Management process across clinical and commercial products, including complaint intake, evaluation, investigation, trending, and regulatory compliance for drug, device, and combination products.
- Establish and maintain statistical processes for complaint trending, action, and alert thresholds.
- Develop and maintain complaint analytics to support product performance monitoring, Management Review, and identification of potential quality trends.
- Support the development and implementation of automated reporting, data visualization, and other analytical tools.
- Oversee development and maintenance of KPIs and metrics supporting Product Quality Complaints Management Reviews.
- Provide technical support for signal detection activities and ensure identified quality signals are appropriately escalated through investigations, CAPAs, or product assessments, as applicable.
- Perform and/or oversee statistical analyses supporting complaint investigations, deviations, CAPAs, Management Review, and quality decision-making.
- Evaluate the effectiveness of CAPAs and quality improvements through product surveillance and trend analysis.
- Develop and maintain global surveillance procedures, work instructions, and quality system documentation related to product complaints supporting FDA, 21 CFR 820, ISO 13485, and other applicable regulatory requirements.

**Who You Are:**

You have aminimumof a Bachelor's degree in related discipline as well as a minimum of 8 years of experience in Quality Assurance, Product Quality, Post-Market Surveillance, or Product Quality Complaint Analytics, including demonstrated experience in data analytics, metrics, reporting, and continuous improvement.

You are or also have:

- A minimum of 3 years of experience leading a highly collaborative team is required.
- Experience leading Post-Market Surveillance, Quality Engineering, or Product Quality activities in a regulated industry.
- Experience managing projects, technical staff, and cross-functional initiatives.
- Experience with complaint handling, investigations, trending, and product performance monitoring.
- Experience developing complaint metrics, statistical trending methods, and action/alert thresholds.
- Working knowledge of FDA Quality System Regulations, cGMPs, Good Documentation Practices, ISO 13485
- Experience supporting deviations, CAPAs, Management Review, and continuous process improvement.
- Experience with Veeva Vault QMS, Qlik, Minitab, or similar analytics tools, highly preferred.
- Excellent analytical, communication, organizational, and problem-solving skills.
- Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).

**WhereYou’llWork**

This is a hybrid role based out of ourBridgewater, NJ office.You’llhave theoptiontowork 2 days of the week remotely, with in-person collaborationwhen it matters most.

\#LI-hybrid

\#LI-EG1

**Pay Range:**

$124,000.00-161,000.00 Annual

**Life at Insmed**

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

Highlights of our U.S. offerings include:

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

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

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

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

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

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

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

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

Sanofi US

Senior Statistical Project Leader

**About the Job:**

Our Evidence Generation and Decision Science (EGDS) group at Sanofi unites Biostatistics, Clinical Statistical Modeling, and Real-World Evidence to revolutionize data-driven decision making through cutting-edge quantitative science and deliver unparalleled integrated evidence that drives innovation and scientific breakthroughs.

Join our EGDS Biostatistics Oncology team as Senior Statistical Project Leader (Director) and youll provide statistical leadership, guidance, and strategic input for clinical studies in one large or impactful projects in solid tumors. Youll have opportunities to develop innovative statistical solutions to support critical trial decision-making and advance treatment across all phases of drug development. EGDS will support your growth through people development and inclusive career opportunities that value diversity of thought and abilities, cultivating future leaders to shape the next generation of clinical science.

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

**About Sanofi**

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

**Main Responsibilities:**

- Serve as a strongly recognized statistical domain leader in both statistical as well as relevant clinical knowledge in the disease domain (solid tumors) to support efficient clinical development planning and study design.
- Provide advanced level of statistical and scientific contributions to clinical development plans, protocol, SAP, CSR, regulatory documents, studies and submissions activities (when applicable), and provide strategic statistical leadership for responsible projects in Sanofis solid tumor pipeline.
- Plan, monitor and manage multiple complex projects directly, including trial activities, timelines, processes, and resources to ensure operational excellence and align practices in compliant with Sanofi SOPs and Biostatistics standards.
- Develop productive collaboration with other functions in the aligned project team, with other statistics project leaders, and in communicating with senior leadership.
- Represent statistics in challenging regulatory meetings (ex: EOP2, Type B/C/D, or Advisory Committee meetings), key scientific or technology working groups or cross function initiatives.

**About You**

**Basic Qualifications:**

- PhD in Statistics or related discipline with at least 8 years of pharmaceutical experience in clinical development, including experience with Biotech, Pharma, Clinical Research Organizations (CROs), health authorities or academic clinical research centers. OR MS in Statistics or related discipline with at least 10 years of pharmaceutical experience in clinical development, including experience with Biotech, Pharma, Clinical Research Organizations (CROs), health authorities or academic clinical research centers.
- Experience publishing research findings, technical articles, or industry insights is preferred.
- Excellent understanding of clinical development; broad knowledge and good understanding of advanced statistical concepts and techniques.
- Experience in Oncology, especially in solid tumors, is a plus.
- Proven successful experience in clinical development such as submissions, interactions with regulatory agencies or other external stakeholders.
- Demonstrated leadership and excellent interpersonal/communication, project management skills.
- Exhibited expertise to represent organizations in cross-company activities (e.g., consortiums or professional associations).

**Why Choose Us?**

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

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

\#GD-SA #LI-SA

\#LI-Hybrid

\#vhd

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

Massachusetts

Associate Director Digital Marketing Rare Hematology

**Job title:**  Associate Director, Digital Marketing, Rare Hematology

**Location:** Cambridge, MA

**About the Job**

The Associate Director, Digital Marketing will lead digital and media strategy across HCP and patient audiences for WAYRILZ (rilzabrutinib) in Immune Thrombocytopenia (ITP).

This role will shape connected, customer-centric digital experiences across the ecosystem, partnering with brand, GTMC, cross-functional teams, and agencies to drive execution, measurement, and ongoing optimization. This position will also champion an AI-Forward Marketing vision and advancing new approaches to AI-enabled content development, personalization, and brand discoverability across emerging AI and LLM-driven experiences.

This role requires strong digital and media expertise, strategic thinking, and a passion for innovation. The position is based in Cambridge, MA and reports to the U.S. ITP Marketing Lead.

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

**About Sanofi**

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

**Main Responsibilities**

**_Digital, Media & Omnichannel Leadership_**

- Own digital and media strategy and execution across HCP and patient audiences, ensuring alignment to brand strategy and business objectives.
- Lead the evolution of HCP and patient journeys, creating more personalized, tailored, and connected experiences across the ecosystem.
- Continuously optimize the channel and investment mix based on performance, customer behavior, and emerging opportunities.
- Translate audience insights into integrated omnichannel strategies across media, CRM, web, GEO, social, third-party platforms, and emerging channels.

**_AI-Forward Marketing & Innovation_**

- Champion new ways to leverage AI across strategy, content, and customer experience.
- Drive adoption of AI-enabled content development to increase speed, scalability, personalization, and channel optimization.
- Monitor the evolving generative AI and LLM landscape and advance strategies that improve brand and disease-state discoverability, relevance, and accuracy across AI-powered experiences.
- Partner with internal teams, agencies, GTMC, and enterprise capabilities to pilot and scale innovative AI and digital solutions.

**_Content & Customer Experience_**

- Champion a customer-first approach, advancing audience segmentation and more relevant content across HCP and patient experiences.
- Partner across agency, media, PRB, and internal teams to improve how digital content is developed, deployed, and optimized.
- Own the WAYRILZ patient DSE campaign and end-to-end digital execution, including partnership with Communications team.

**_Performance, Analytics & Optimization_**

- An especially important aspect of this role will be to partner with GTMC to establish KPIs, measurement frameworks, and ongoing analytics tied to customer behaviors and business objectives.
- Lead ongoing performance reviews across HCP and patient digital activities and translate insights into clear recommendations for the broader WAYRILZ commercial team.
- Consistently optimize investment toward the highest-performing audiences, channels, and tactics.
- Foster a test, learn, and optimize mindset, using data and experimentation to continuously improve marketing effectiveness.

**About You**

**Basic Qualifications:**

- 5+ years of experience in pharmaceutical/biopharmaceutical industries or advertising agencies serving pharma clients (both agency and client-side experience accepted)
- **Brand/Digital marketing** and customer experience planning.
- Strategic digital planning and execution.
- Building cross functional consensus.
- **In-depth understanding of digital marketing channels** and the key benefits that each achieve at driving enhanced customer relationships.
- Strong understanding of digital marketing, AI, trends and innovations.
- Agency management.
- Regulatory review experience.
- Identifies and solves digital marketing challenges proactively.
- Demonstrates solution-oriented approach and proficient problem-solving skills.

**Preferred Qualifications:**

Competencies and expectations associated with this role include but are not limited to the following:

- Familiarity with brand strengths, opportunities, competitive challenges, and key attributes of the brand lifecycle to support the execution of digital engagement activities to drive desired behavior change.
- Constant focus on enabling the best customer experience in every interaction.
- Familiar with actionable digital measurement plans, selecting KPIs and setting goals, targets and measurement milestones that directly relate to business objectives.
- Active pursuit of data & insight-based steering of digital investments; Shares insights and shape recommendations based on behavioral and performance data to assess campaign lift and ROI.
- Ability to adapt to the ever-changing digital landscape to identify areas of opportunity delivering the most impact for the brand.

**_Culture and People:_**

- Works well in a highly matrixed environment to successfully partner with cross-functional teams, and agency partners.
- Self-starter, proactive in nature with strong communication and presentation skills

**Why Choose Us?**

- Bring the miracles of science to life alongside a supportive, future\[1\]focused team.
- Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave.

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

\#GD-SG

\#LI-GZ

\#LI-Onsite

\#vhd

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

Eli Lilly and Company

MES Technical Lead / Systems Architect LP2

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.

**LP2 MES Technical Lead & Systems Architect — Lebanon, Indiana**

Lilly is building a new gene therapy manufacturing site (LP2) in Lebanon, Indiana. This role owns the Manufacturing Execution System (MES) end-to-end — from the Tulip application layer and Tulip Table data model, through MuleSoft integrations connecting SAP, QbDVision, and LabVantage, to the MQTT-based Unified Namespace driving real-time equipment communication. You will serve as both the technical authority over the platform’s architecture and the hands-on engineer responsible for its ongoing design, build, and validation.

**Key Responsibilities**

- Serve as Technical Lead/SME for LP2 MES architecture, design standards, and technical direction

- Design, build, and validate Tulip applications for GxP manufacturing workflows and electronic batch records

- Direct automation integrations with Automation Engineering (equipment commands, confirmations, process value subscriptions)

- Author/approve design specs ensuring compliance with ALCOA+ and 21 CFR Part 11

- Guide components through validated migration lifecycle (DEV → QA → Production)

- Participate in Change Control Board (CCB) and ServiceNow change management

- Partner with Manufacturing Operations, Automation Engineering, and Quality (BQA/CSQA)

- Mentor MES engineers; act as escalation point for complex issues

- Collaborate with MES Product Owner on ALM requirements/backlog

- Report system status and technical risk to site/IT leadership

**Basic Requirements**

- Bachelor's degree in IT, Software/Computer Engineering or related field

- 5+ years with MES or pharma manufacturing IT platforms, including system integration (middleware/ERP/PLM) and Computer System Validation (CSV) in GMP settings

- 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.

**Additional Skills/Preferences**

- Modern software architecture and integration patterns

- MuleSoft/Anypoint, DataWeave for MES–ERP(SAP)–PLM integrations

- MQTT, Unified Namespace (UNS), OPC UA knowledge

- CSV experience: Validation/Test Plans, IQ/OQ/UAT, design specs under 21 CFR Part 11/ALCOA+

- Understanding of eBRs, non-terminal record controls, e-signatures

- Git/GitHub, GitHub Actions, MUnit, ALM/Jira

- Familiarity with MABL and ServiceNow

- Strong cross-functional communication and problem-solving skills

**Additional Information:**

- Position Location: Lebanon, Indiana, with potential travel to other U.S. and global Lilly sites as required.

- Travel Percentage (%): \<10

- Shift Information: Role is Monday through Friday and based on-site. Must be flexible in providing support to accommodate production schedules, batch execution windows, and change control activities. Occasional extended hours and/or off-hour support may be required.

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

$129,000 - $211,200

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

Indiana

Insikt Analytics

Scientific LIMS Business Analyst

Senior LIMS Business Analyst

**Location:**  Tarrytown, NY  
**Job Type:**  Contract | 40 hours/week  
**Engagement:**  Corp-to-Corp  
**Pay:**  $70–$75/hour C2C  
**Work Location:**  On-site in Tarrytown, NY

Must-Have Qualifications

**This position requires hands-on Business Analyst experience supporting LIMS within a pharmaceutical or biotechnology laboratory environment. Candidates without both LIMS and Business Analysis experience will not be considered.**

To qualify, you must have:

- 5+ years of hands-on Business Analyst or Business Systems Analyst experience.
- 3+ years supporting LIMS within a pharmaceutical, biotechnology, bioanalytical, clinical, preclinical, or R&D laboratory environment.
- Direct experience gathering and documenting requirements for LIMS implementations, enhancements, or laboratory workflow solutions.
- Experience translating scientific and laboratory workflows into business, functional, and system requirements.
- Experience creating BA deliverables such as user stories, functional requirements, process flows, workflow diagrams, requirements traceability, acceptance criteria, and UAT scenarios.
- Working knowledge of regulated laboratory environments, data integrity, validation, and GxP principles.
- Ability to work directly with scientists, laboratory users, product owners, developers, architects, and other technology stakeholders.
- Ability to work on-site in Tarrytown, NY as required.

Position Summary

Insikt Analytics is seeking a **Senior LIMS Business Analyst** to support Research IT initiatives for a leading biopharmaceutical organization in Tarrytown, NY.

The position will focus on Laboratory Information Management Systems supporting clinical and preclinical research and sample-management workflows.

The Business Analyst will work directly with scientists, laboratory teams, and technology stakeholders to understand scientific processes, analyze laboratory workflows, define requirements, and translate business needs into scalable technology solutions.

This is a hands-on Business Analysis position requiring direct ownership of requirements and laboratory workflows.

Responsibilities

- Partner directly with scientists and laboratory personnel to understand clinical and preclinical research workflows.
- Gather, analyze, document, and validate business, functional, and system requirements for LIMS solutions.
- Facilitate requirements workshops and stakeholder interviews.
- Document current-state and future-state laboratory workflows.
- Translate scientific and laboratory requirements into clear specifications for development and technical teams.
- Create user stories, functional requirements, acceptance criteria, process flows, and requirements traceability documentation.
- Support LIMS enhancements and implementations involving sample receipt, tracking, storage, inventory, processing, testing, results, and reporting.
- Identify gaps and opportunities to improve laboratory workflows, sample management, data quality, reporting, and operational efficiency.
- Partner with technical teams throughout design, development, testing, and deployment.
- Support UAT by defining scenarios, validating requirements coverage, and coordinating with business users.
- Support validation and documentation activities within regulated laboratory environments.
- Serve as the primary liaison between scientific stakeholders and technology teams.
- Manage assigned BA deliverables independently and communicate risks, dependencies, and requirements decisions clearly.

Required ExperienceLIMS / Laboratory Informatics

- Hands-on experience supporting a LIMS implementation, enhancement, or major laboratory informatics initiative.
- Understanding of laboratory sample lifecycle and sample-management workflows.
- Experience working with clinical, preclinical, bioanalytical, research, or other scientific laboratory environments.

Business Analysis

Candidates must have recent hands-on experience personally performing core Business Analyst responsibilities, including:

- Requirements elicitation
- Business and functional requirements
- User stories and acceptance criteria
- Process and workflow mapping
- Requirements analysis
- Current-state / future-state analysis
- Requirements traceability
- UAT planning and requirements validation
- Business-to-technology translation

Experience primarily limited to coordination, leadership, testing, or administrative project activities does not satisfy the Business Analyst requirement.

Pharma / Biotech

- 3+ years of experience within pharmaceutical, biotechnology, life sciences, or bioanalytical environments.
- Understanding of scientific research and laboratory terminology.
- Familiarity with regulated systems, validation, GxP, and data-integrity principles.

Preferred Qualifications

- Experience supporting Research IT or R&D Informatics within a pharmaceutical or biotechnology company.
- Experience with clinical or preclinical sample management and/or biobanking workflows.
- Experience with ELN platforms.
- Familiarity with LIMS integrations, data flows, APIs, or laboratory-system interfaces.
- Familiarity with AWS-hosted environments.
- Knowledge of CSV, 21 CFR Part 11, and regulated system validation.
- Bachelor's degree in Life Sciences, Information Systems, Computer Science, Engineering, or a related discipline.

Contract Requirements

This is a Corp-to-Corp contract engagement.

Applicants must be able to work on-site in Tarrytown, NY as required.

**If applicable:**  Direct C2C consultants only. Third-party staffing/vendor submissions are not being accepted for this position.

Application Screening Questions

Please answer all questions accurately. The first five qualifications are required for consideration.

- Have you personally worked as a Business Analyst or Business Systems Analyst on a LIMS implementation or major LIMS enhancement project?
- How many years of hands-on LIMS Business Analyst experience do you have?
- Which LIMS platforms have you worked with? Please list the platform name(s) and briefly describe your role.
- Have you personally created requirements, user stories, process flows, acceptance criteria, requirements traceability, or UAT documentation for a LIMS project?
- Do you have at least 3 years of pharmaceutical, biotechnology, bioanalytical, or life-sciences laboratory systems experience?
- Describe one LIMS project where you gathered requirements directly from scientists or laboratory users. What was your responsibility?
- Do you have experience with clinical/preclinical sample management, biobanking, or bioanalytical laboratory workflows?
- How many years of GxP, CSV, validation, or regulated laboratory-system experience do you have?
- Are you able to work on-site in Tarrytown, NY as required?
- Are you able to work under a Corp-to-Corp engagement?

Job Types: Contract, Full-time

Application Question(s):

- Are you able to work under a Corp-to-Corp engagement?
- Are you able to work on-site in Tarrytown, NY as required?
- Have you personally worked as a Business Analyst or Business Systems Analyst on a LIMS implementation or major LIMS enhancement project?
- Which LIMS platforms have you worked with? Please list the platform name(s) and briefly describe your role.
- Do you have at least 3 years of pharmaceutical, biotechnology, bioanalytical, or life-sciences laboratory systems experience?

Work Location: In person