Senior Director, Clinical Pharmacology
$237,400–$298,900 year
On-site · Warren Township, New Jersey, United States
Job Summary
Senior Director, Clinical Pharmacology responsible for providing hands-on support for Clinical Pharmacology within Clinical Development, designing, conducting, and overseeing PK & PK/PD assessments in patients, and interpreting data to support programs. Acts as the lead clinical pharmacologist for clinical stage programs, designs and manages PK/PD, PBPK, popPK, DDI, and related studies; develops and writes regulatory documents (IB, protocols, study reports, IND/NDA, eCTDs); collaborates with cross-functional teams and external CROs; provides project management support for select projects; mentors junior staff; ensures adherence to regulatory requirements and SOPs.
Required Qualifications
- Ph.D., Pharm.D. or equivalent academic training in pharmacokinetics, pharmaceutical sciences or a related discipline and a minimum of 9 years of relevant and progressively responsible experience in clinical pharmacology including extensive experience in DMPK
- Broad understanding of clinical pharmacology & DMPK relevant areas such as PK assessment in patients, exposure–response relationships, PK modeling, DDI, physicochemical properties, drug metabolizing enzyme & transporter kinetics, pharmacokinetics, mechanistic biotransformation, and analytical sciences
- Proficiency in NCA PK (WinNonlin) and hands-on experience in PBPK and popPK modeling
- Leads clinical pharmacology strategy and communicates data-driven recommendations effectively to both technical and non-technical stakeholders
- Experience in managing projects; ability to work with regulatory guidelines for clinical pharmacology & DMPK packages to support drug development
- Excellent verbal and written communication skills; ability to work independently and collaboratively in a fast-paced, matrixed environment
- Demonstrated leadership ability and ability to influence without direct authority
- Travel up to 10%
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