Director, Clinical Pharmacology
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 Director, Clinical Pharmacology and Pharmacometrics reports to the Head of CPP within Global Clinical Development. This translational role within the Clinical Development organization supports both Research and Development. The Director Clinical Pharmacology position will support the clinical pharmacology programs for an expanding portfolio of therapeutics across several disease areas. This role will independently execute routine clinical pharmacology tasks with minimum supervision and will include oversight of vendors and/or contractors. The role requires a leader who leverages strong scientific expertise, sound decision making, and strong collaboration skills to drive alignment across teams on nonclinical and clinical development strategies. They oversee or conduct the analyses necessary to interpret collected data and provide strategic expertise to advance development decisions within a dynamic, matrixed environment
Requirements
- PhD in Pharmacokinetics, Pharmacology, Pharmaceutics or M.D. or PharmD with equivalent experience or Master’s degree in Pharmacokinetics, Pharmacology, Pharmaceutics
- Minimum of 10 years (for PhD, MD or PharmD) or 12+ years (for Master’s) of experience in the pharmaceutical industry
- Demonstrated knowledge in pharmacokinetics and modeling, PKPD principles, ADME concepts, and clinical pharmacology
- Demonstrated experience with drug development programs and with clinical pharmacology related regulatory guidelines
- Expert knowledge of pharmacokinetic, modeling and data visualizations software
- Strong (English) communication skills (verbal and written) and presentation skills are required
- Excellent interpersonal skills and the ability to function in a highly matrixed team environment are essential
- Demonstrated problem solving and critical thinking skills
Responsibilities
- Represent Clinical Pharmacology and provide PKPD support to projects assigned by the Group Lead
- Independently lead and oversee the analysis, interpretation, integration and reporting of clinical pharmacokinetic & pharmacodynamic data of assigned projects.
- Review and Design Clinical Pharmacology development strategies to facilitate new drug development and drug approval
- Provide Model-based development input, including PPK analysis, for overall clinical development strategy
- Design and conduct PK/PD analyses to guide development decisions of project teams.
- Provide PKPD input for regulatory submissions such as briefing documents, IND, CTA and NDA.
- Prepare appropriate documents or sections of clinical protocols, Investigator Brochures, Clinical Study Reports with respect to Clinical Pharmacology studies or data.
- Preparation of abstracts and manuscripts for publication.
- Closely partner with Research, Clinical functions, Regulatory, Project Management, and other R&D functions. Participate in preclinical study design and documentation as they relate to Translational activities needed in advance of planned clinical development programs.
- 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.
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
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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
