Director, Translational Bioanalytical Sciences

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:

What You'll Do:

In this role, you’ll have the opportunity to provide scientific leadership and strategic oversight for the development, qualification, validation, and implementation of bioanalytical, biomarker, pharmacodynamic, immunogenicity, and translational assays across all therapeutic modalities . You’ll also:

• Partner with cross-functional stakeholders, including Therapeutic Area teams, Clinical Pharmacology, Clinical Operations, Nonclinical Safety, Regulatory Affairs, Biometrics, and external collaborators, to develop and execute integrated Translational Bioanalytical and Biomarker strategies that support clinical development programs.

• Serve as the TBAS representative on global project teams, contributing to development strategy, decision-making, and regulatory interactions throughout the product lifecycle.

• Lead assay development and validation activities both internally and through external partners/CROs, ensuring compliance with applicable regulatory guidance and industry best practices, including FDA, EMA, ICH, and CLSI standards (e.g., ICH M10 Bioanalytical Method Validation).

• Drive the planning, execution, and oversight of regulated and non-regulated bioanalytical testing in support of preclinical and clinical studies, ensuring generation of high-quality, fit-for-purpose data.

• Support the design and execution of clinical studies by providing input into protocols, statistical analysis plans, laboratory manuals, biomarker plans, and sample management strategies.

• Author, review, and provide scientific input to regulatory and clinical development documents, including INDs, CTAs, NDAs, BLAs, PMAs, Investigator's Brochures, Briefing Books, Clinical Study Reports, and other health authority submissions and communications.

• Interpret and integrate bioanalytical and biomarker data to generate actionable insights that inform dose selection, proof-of-mechanism, proof-of-biology, patient stratification, and key development decisions.

• Establish and maintain effective vendor governance processes, including identification, selection, qualification, contracting, and performance management of bioanalytical and biomarker service providers in partnership with Procurement and Quality organizations.

• Oversee external CROs and contract laboratories conducting preclinical and clinical bioanalytical activities, ensuring adherence to scientific, quality, compliance, budget, and timeline expectations.

• Provide mentorship, scientific guidance, and technical leadership across the organization, fostering innovation, operational excellence, and adoption of emerging bioanalytical technologies and translational approaches.

Who You Are:

You have a PhD in Analytical Chemistry, Pharmacokinetics, Pharmacology, Pharmaceutics, Bioanalytical Sciences, or a related discipline, along with a minimum of 10 years of progressive experience in the biopharmaceutical or pharmaceutical industry, with substantial experience supporting translational sciences, bioanalysis, biomarkers, and clinical development. You are or also have:

• Proven leadership experience building, developing, and mentoring high-performing scientific teams, including Associate Directors, Principal Scientists, and senior technical staff.

• Industry recognized scientific expertise in advanced bioanalytical technologies, particularly LC-MS/MS, with demonstrated experience across small molecules, biologics, oligonucleotides, peptides, and emerging multimodality therapeutics.

• Demonstrated success leading complex bioanalytical and translational programs within matrixed, cross-functional, and global development organizations.

• Extensive experience designing, managing, and interpreting bioanalytical studies conducted in both regulated (GLP, GCLP, GCP) and non-regulated environments.

• Strong expertise in bioanalytical method development, qualification, validation, and lifecycle management, with a deep understanding of applicable regulatory guidance and industry best practices.

• Demonstrated experience managing external partnerships, including CRO selection, oversight, governance, performance management, contract negotiations, and strategic outsourcing initiatives.

• Strong understanding of drug development from early discovery through late-stage clinical development and regulatory approval, with the ability to translate scientific findings into development and registration strategies.

• Proven track record of effective participation and leadership within cross-functional and global project teams, driving scientific alignment and influencing strategic decision-making.

• Deep knowledge of global regulatory requirements and expectations related to bioanalytical sciences, biomarkers, and immunogenicity, including direct experience supporting interactions with health authorities and regulatory submissions.

• Experience supporting successful regulatory filings and approvals, including INDs, CTAs, NDAs, BLAs, and other global submissions.

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 domestic travel, approximately 10%.

#LI-TB1

#LI-Hybrid

Pay Range:

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 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  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.