Director, Translational Bioanalytical Sciences
Insmed Incorporated
August 13, 2026
Remote friendly (Bridgewater, NJ)
United States
Clinical Research and Development
About The Role
Director, Translational Bioanalytical Sciences (Clinical Development, Translation Bioanalytical Science). Lead 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.
What You'll Do
- Provide scientific leadership and strategic oversight for development/qualification/validation/implementation of bioanalytical, biomarker, pharmacodynamic, immunogenicity, and translational assays across modalities.
- Partner with cross-functional teams to develop and execute integrated Translational Bioanalytical and Biomarker strategies.
- Serve as TBAS representative on global project teams for strategy, decisions, and regulatory interactions.
- Lead assay development and validation (including via CROs/partners) ensuring compliance with FDA/EMA/ICH/CLSI (e.g., ICH M10).
- Plan and oversee regulated/non-regulated bioanalytical testing supporting preclinical and clinical studies.
- Support clinical study design with input into protocols, SAPs, lab manuals, biomarker plans, and sample management.
- Author/review scientific input to INDs, CTAs, NDAs, BLAs, PMAs, Investigator’s Brochures, Briefing Books, Clinical Study Reports, and other submissions.
- Interpret and integrate data to inform dose selection, proof-of-mechanism/bio(ology), patient stratification, and key decisions.
- Establish vendor governance; oversee external CROs/contract labs for quality, compliance, budget, and timelines.
- Mentor and provide technical leadership; drive adoption of emerging technologies.
Who You Are (Qualifications)
- PhD in Analytical Chemistry, PK, Pharmacology, Pharmaceutics, Bioanalytical Sciences, or related field.
- 10+ years progressive biopharma/pharma experience in translational sciences, bioanalysis, biomarkers, and clinical development.
- Leadership experience building/mentoring scientific teams.
- Expertise in advanced bioanalytical technologies, especially LC-MS/MS, across modalities.
- Experience in regulated and non-regulated bioanalytical study design/management/interpretation.
- Strong knowledge of method development/qualification/validation/lifecycle management and regulatory guidance.
- Experience managing CRO/partner governance and outsourcing.
- Broad understanding of drug development and translating science to development/registration strategy.
- Track record across global cross-functional project teams.
- Deep regulatory knowledge (bioanalytical, biomarkers, immunogenicity) including health authority interactions and filings (IND/CTA/NDA/BLA/global submissions).
Benefits (U.S. offerings)
- Medical, dental, vision, mental health support, wellbeing reimbursement, EAP.
- Paid time off; fertility/family-forming, caregiver support; flexible schedules with purposeful in-person collaboration.
- 401(k) with match; annual equity awards; ESPP; company-paid life/disability.
- Learning/mentorship via Company Learning Institute; resource groups and recognition.
Application instructions
- Current Insmed employees: apply via the Jobs Hub in Workday.
Director, Translational Bioanalytical Sciences (Clinical Development, Translation Bioanalytical Science). Lead 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.
What You'll Do
- Provide scientific leadership and strategic oversight for development/qualification/validation/implementation of bioanalytical, biomarker, pharmacodynamic, immunogenicity, and translational assays across modalities.
- Partner with cross-functional teams to develop and execute integrated Translational Bioanalytical and Biomarker strategies.
- Serve as TBAS representative on global project teams for strategy, decisions, and regulatory interactions.
- Lead assay development and validation (including via CROs/partners) ensuring compliance with FDA/EMA/ICH/CLSI (e.g., ICH M10).
- Plan and oversee regulated/non-regulated bioanalytical testing supporting preclinical and clinical studies.
- Support clinical study design with input into protocols, SAPs, lab manuals, biomarker plans, and sample management.
- Author/review scientific input to INDs, CTAs, NDAs, BLAs, PMAs, Investigator’s Brochures, Briefing Books, Clinical Study Reports, and other submissions.
- Interpret and integrate data to inform dose selection, proof-of-mechanism/bio(ology), patient stratification, and key decisions.
- Establish vendor governance; oversee external CROs/contract labs for quality, compliance, budget, and timelines.
- Mentor and provide technical leadership; drive adoption of emerging technologies.
Who You Are (Qualifications)
- PhD in Analytical Chemistry, PK, Pharmacology, Pharmaceutics, Bioanalytical Sciences, or related field.
- 10+ years progressive biopharma/pharma experience in translational sciences, bioanalysis, biomarkers, and clinical development.
- Leadership experience building/mentoring scientific teams.
- Expertise in advanced bioanalytical technologies, especially LC-MS/MS, across modalities.
- Experience in regulated and non-regulated bioanalytical study design/management/interpretation.
- Strong knowledge of method development/qualification/validation/lifecycle management and regulatory guidance.
- Experience managing CRO/partner governance and outsourcing.
- Broad understanding of drug development and translating science to development/registration strategy.
- Track record across global cross-functional project teams.
- Deep regulatory knowledge (bioanalytical, biomarkers, immunogenicity) including health authority interactions and filings (IND/CTA/NDA/BLA/global submissions).
Benefits (U.S. offerings)
- Medical, dental, vision, mental health support, wellbeing reimbursement, EAP.
- Paid time off; fertility/family-forming, caregiver support; flexible schedules with purposeful in-person collaboration.
- 401(k) with match; annual equity awards; ESPP; company-paid life/disability.
- Learning/mentorship via Company Learning Institute; resource groups and recognition.
Application instructions
- Current Insmed employees: apply via the Jobs Hub in Workday.