Associate Director, Drug Metabolism and Pharmacokinetics

Insmed Incorporated

1d • $164,000 - $213,000 • Remote

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: The Associate Director DMPK will be accountable for the non-clinical pharmacokinetics and drug metabolism components of drug discovery and development programs at Insmed, including small and large molecules. The Associate Director DMPK is expected to have in-depth DMPK knowledge and hands-on experience, and be familiar with pharmaceutical drug discovery and development. This role will work collaboratively with other team members and provide oversight of vendors.

Requirements

• PhD in pharmacokinetics, pharmaceutical sciences or related scientific discipline with a minimum of 8 years of biotech/pharmaceutical drug discovery and development experience.
• Expertise with in vitro and in vivo DMPK studies.
• Previous involvement in both drug Discovery and drug Development programs is a plus.
• Experience vetting and collaborating with CROs on a wide range of studies.
• Ability to plan, organize, and critically assess and perform PK/PD data analyses..
• Experience preparing DMPK sections of regulatory submissions.
• Excellent oral and written communication skills.
• Problem solving and critical thinking skills are essential.

Nice To Haves

• Familiarity in development of protein therapeutics, antisense oligonucleotides and/or gene therapies is a plus.
• Hands-on experience with Phoenix WinNonlin, NONMEM, R and/or ADME prediction software is a plus.

Responsibilities

• Serve as a DMPK lead on assigned project teams, responsible for strategy and execution of non-clinical drug metabolism programs for small and large molecules in Discovery and Development.
• Participate in the design, data analysis and interpretation of DMPK and non-clinical PK/PD studies.
• Support TK study design and data interpretation.
• Author DMPK sections of regulatory submissions such as briefing books, INDs, CTAs and NDAs.
• Provide CRO oversight for in vitro and in vivo DMPK studies.
• Work with in-house laboratory to expand DMPK capabilities.
• Closely partner with Research, Toxicology, Clinical Development, Regulatory, Project Management, and other functions.
• Participate in the design, data analysis and interpretation of DMPK and non-clinical PK/PD studies.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree
• Number of Employees: 501-1,000 employees