Director, Translational Bioanalytical Sciences
About The Position
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, Translational Bioanalytical Sciences on the Clinical Development, Translation Bioanalytical Science team to help us expand what’s possible for patients with serious diseases. Reporting to the Head of Translational Bioanalytical Sciences, you’ll be responsible for the development, validation, and strategic application of bioanalytical and biomarker assays, supporting small molecules, biologics, and emerging mixed-modality therapeutics from early development through clinical evaluation. Positioned within the Clinical Development organization, the role partners closely with cross-functional stakeholders, including Clinical Pharmacology, Translational Medicine, Regulatory Affairs, and multiple Research organizations, to advance program objectives and inform critical development decisions.
Requirements
- PhD in Analytical Chemistry, Pharmacokinetics, Pharmacology, Pharmaceutics, Bioanalytical Sciences, or a related discipline.
- 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.
- 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.
Responsibilities
- 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.
- 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.
Benefits
- Comprehensive medical, dental, and vision coverage
- Mental health support
- Annual wellbeing reimbursement
- Access to our Employee Assistance Program (EAP)
- Generous paid time off policies
- Fertility and family-forming benefits
- Caregiver support
- Flexible work schedules
- Purposeful in-person collaboration
- 401(k) plan with a competitive company match
- Annual equity awards
- Participation in our Employee Stock Purchase Plan (ESPP)
- 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
- Meaningful opportunities to connect, volunteer, and give back
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
