Associate Director, Drug Metabolism and Pharmacokinetics
Insmed Incorporated
10 hours ago
Remote
United States
Clinical Research and Development
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, including small and large molecules. This role collaborates with team members and provides oversight of vendors.
What You’ll Do
- Serve as a DMPK lead on assigned project teams; drive 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.
- Partner closely with Research, Toxicology, Clinical Development, Regulatory, Project Management, and other functions.
Qualifications
- PhD in pharmacokinetics, pharmaceutical sciences, or a 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.
- 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 Have (Not Required)
- Familiarity with development of protein therapeutics, antisense oligonucleotides, and/or gene therapies.
- Hands-on experience with Phoenix WinNonlin, NONMEM, R, and/or ADME prediction software.
Work Location / Travel
- Fully remote role; occasional travel for team meetings/events.
Application Instructions
- Current Insmed employees: apply via the Jobs Hub in Workday.
The Associate Director DMPK will be accountable for the non-clinical pharmacokinetics and drug metabolism components of drug discovery and development programs, including small and large molecules. This role collaborates with team members and provides oversight of vendors.
What You’ll Do
- Serve as a DMPK lead on assigned project teams; drive 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.
- Partner closely with Research, Toxicology, Clinical Development, Regulatory, Project Management, and other functions.
Qualifications
- PhD in pharmacokinetics, pharmaceutical sciences, or a 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.
- 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 Have (Not Required)
- Familiarity with development of protein therapeutics, antisense oligonucleotides, and/or gene therapies.
- Hands-on experience with Phoenix WinNonlin, NONMEM, R, and/or ADME prediction software.
Work Location / Travel
- Fully remote role; occasional travel for team meetings/events.
Application Instructions
- Current Insmed employees: apply via the Jobs Hub in Workday.