Associate 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:

We’re looking for an Associate Director, Translational Bioanalytical Sciences (TBAS) within the Clinical Development team to help us expand what’s possible for patients with serious diseases. In this role, you’ll lead regulated LC-MS/MS bioanalytical activities supporting small molecules, oligonucleotides, and biologic therapeutics, with primary responsibility for small molecule programs. The role is accountable for the development, validation, oversight, and monitoring of regulated bioanalytical methods and sample analysis supporting clinical, nonclinical, and biomarker studies. Working closely with cross-functional teams across Clinical Development and Research, you will provide scientific and strategic leadership on bioanalytical and biomarker strategies, guide assay development and biomarker selection, and oversee both internal and CRO resources to ensure high-quality, phase-appropriate bioanalytical support across the portfolio.

What You'll Do:

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

• Lead bioanalytical activities across therapeutic programs, providing oversight of outsourced GxP method development, validation, and sample analysis from IND-enabling studies through late-stage development for PK, PD, and biomarker endpoints
• Ensure bioanalytical deliverables are executed to the highest scientific and quality standards while meeting project timelines. Oversee and manage work conducted by CROs and internal partners within a matrixed environment, providing strategic guidance and governance rather than hands-on laboratory support
• Collaborate with multiple internal and external stakeholders (therapeutic areas, clinical pharmacology, clinical operations, non-clinical safety, contract research organizations etc.) to build and to execute the bioanalytical strategy specific to clinical development programs
• Provide technical expertise on sample preparation, chromatography, mass spectrometric instrumentation, stability, and other method related issues
• Participate in clinical study design and documentation (lab manual, protocol, report, SAP)
• Participate in pre-clinical study design and documentation as needed
• Contribute to regulatory document writing (e.g., IB, IND, Integrated Summary of Immunogenicity)
• Engage in scientific advice meetings with regulatory authorities (FDA, EMA, PMDA)
• Participate in vendor governance and identify, evaluate, and manage bioanalytical vendors, partnering with the Procurement function

Who You Are:

You have a PhD or MS in Analytical Chemistry, Chemistry, Biochemistry, or another relevant field along with minimum of 10 years’ post-doctoral experience or equivalent in the pharmaceutical or related industry within bioanalytical area focusing on small molecules and oligonucleotides.  You are or you also have:

• Demonstrated method development and validation experience with various platforms with deep expertise in LC/MS regulated quantification
• Experience managing regulated low molecular weight LC/MS analysis at external service providers
• Demonstrated expertise in best practices recommended by FDA, EMA, CLSI to conduct development, qualification, and validation of assays (e.g., M10 Bioanalytical Method Validation)
• Advanced knowledge of various mass spectrometry platforms, ionization methods, quantitative analysis techniques for small molecules, hybrid, or biological molecules (eg. proteins, peptides, oligonucleotides, etc.)
• Strong understanding and experience current GxP, ICHM10, CAP/CLIA/ISO standards
• Excellent people skills and the ability to function in a highly matrixed team environment
• Familiarity and experience in establishing clinical biomarker analyses for clinical trials
• Excellent communication skills (verbal and written) and presentation skills

Nice to Have (but not required):

• Knowledge of ligand binding, flow cytometry, qPCR, cell-based assays and other biological detection and sample preparation techniques
• Knowledge of LIMS systems such as Watson or other data systems is considered a bonus

Where You’ll Work

This is a hybrid role based out of our [City, Country] 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/international travel (approximately 5%–15%)

#LI-Hybrid

#LI-TB1

Pay Range:

$164,000.00-213,000.00 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. 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.