Director of Clinical Biomarkers

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 of Clinical Biomarkers on the Clinical Development team to help us expand what's possible for patients with serious diseases. Reporting to the Executive Director, Translational Bioanalytical Science , you'll lead identification and validation of clinical biomarkers to support decision-making across the clinical development lifecycle for all therapeutic areas at Insmed. We are seeking a highly motivated partner across functions to design and deliver biomarker strategies that connect drug mechanism, patient biology, and clinical endpoints across immune-mediated and inflammatory diseases. This translational role within the Clinical Development organization works closely with colleagues in other functional areas including multiple Research groups. This is a hybrid role, expected to be in the office weekly.

What You'll Do:

In this role, you'll have the opportunity to drive the scientific strategy and implementation of biomarker plans to support clinical development programs. This role will provide leadership across external CROs and specialty laboratories and will conduct both technical and strategic evaluations of emerging and innovative biomarker platforms to advance Insmed's development pipeline.

The role requires a leader who leverages deep scientific expertise, sound decision-making, and strong collaboration skills to drive alignment across teams on biomarker hypotheses, strategies, and readouts that inform key development decisions within a dynamic, matrixed environment. You'll also:

• Collaborate with multiple internal and external stakeholders (therapeutic areas, clinical pharmacology, clinical operations, non-clinical safety, contract research organizations etc.) to build and execute the biomarker strategy specific to clinical development programs.
• Identify, develop, and validate translational and clinical biomarker assays across pharmacokinetics, immunogenicity (ADA and NAb assays), pharmacodynamics, and predictive endpoints.
• Lead method development of clinical biomarker assays for Global Clinical Development both in-house and at external CROs across all modalities.
• Participate in preclinical study design and documentation as they relate to Translational activities needed in advance of planned clinical development programs.
• Perform in-depth scientific literature review to help address critical questions relating to target biology, clinical relevance, and associated assays.
• Participate in clinical study design and documentation (lab manual, protocol, SAP).
• Provide input into applicable sections of clinical documents, consolidating feedback from SME, including study protocols, regulatory documents and communications (IND, NDA, BLA, PMA, etc.), Briefing Book (BB), Investigatory Brochure(IB), Clinical Study Reports (CSR), study start up (e.g. ICF, data transfer agreements) and data base lock activities (e.g. sample reconciliation, data review/QC and transfer), etc.
• Providing consultation and technical support for preclinical and clinical Immunogenicity strategy discussions within Global BA and providing data interpretation consistent with current industry and health authority expectations.
• Participate in clinical study design and documentation (lab manual, protocol, SAP.
• Manage and monitor externally contracted laboratories for regulated preclinical and clinical work, ensuring quality data generation and reporting.

Who You Are:

You have a PhD in Analytical, Pharmacokinetics, Pharmacology, Pharmaceutics or another relevant field or M.D. or PharmD with equivalent experience, along with 10+ years of experience in the pharmaceutical industry.

You are or you also have:

• Significant proven expertise in rare and respiratory diseases, including a deep understanding of:
  
  • Biomarker identification and strategic implementation in clinical studies
  • Therapeutic modalities and advanced analytical techniques for measurement (small molecules, oligonucleotides and monoclonal antibodies and other proteins.)
  • Disease mechanisms/pathways
• Strong knowledge of advanced analytical techniques for multi-omics analyses, high resolution mass spectrometry, qPCR techniques and cellular assays preferred (ex. Flow Cytometry assays, receptor occupancy assays, cellular immunogenicity assays).
• Strong knowledge of integrated immunogenicity data interpretation especially in conjunction with safety/PK/clinical data.
• Experience within immunology, neurology and/or respiratory therapeutic areas, and experience supporting novel modalities.
• Proficient in analyzing and interpreting complex in vitro, in vivo and in situ data and clinical datasets.
• Strong track record in translational science or pharmaceutical development in industry.
• Strong understanding and experience with relevant quality systems (GLP, GCLP, GCP etc.)
• Strong communication skills (verbal and written) and presentation skills are required.
• Experience in global regulatory interactions, including successful INDs, NDAs, or CTAs

#LI-TB1

#LI-Hybrid

Pay Range:
$185,000.00-252,500.00 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.

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 [email protected] 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.