Director, Translational Bioanalytical Sciences

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?

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.

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.

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…