Sr. Director, Clinical Pharmacology and Translational PK/PD
Responsibilities:
- Oversee clinical pharmacology and translational PK/PD operations and deliverables across preclinical and clinical development for infectious disease and oncology programs.
- Serve as technical expert on cross-functional teams; provide strategic input to program advancement.
- Develop fit-for-purpose clinical pharmacology strategies from pre-IND through market authorization.
- Select and execute PK/PD, PopPK, and exposure-response modeling/simulation to support dose selection, optimization, and justification for Phase 2 and pivotal trials.
- Author and provide technical input for regulatory documents and submissions (protocols, IBs, briefing packages, INDs, NDAs/BLAs) and responses to questions.
- Collaborate with clinical research/operations, biomarkers, bioanalytical, biometrics, CMC, research, and regulatory.
- Establish/manage collaborations with external vendors and partners.
- Manage departmental budgets and optimize resource allocation across programs.
- Manage and develop the Clinical Pharmacology and Translational PK/PD team (hiring, mentoring, capability building).
Qualifications:
- PhD, PharmD, or MD with 13+ years industry experience in Clinical Pharmacology, DMPK, or related field.
- Expertise in nonclinical/clinical PK concepts; strong multidisciplinary drug development understanding.
- Proficiency in PK/PD, PopPK, exposure-response modeling; R proficiency; hands-on Monolix or NONMEM experience.
- Regulatory knowledge with experience supporting submissions/engagements.
- Working knowledge of bioanalytical techniques.
- Biologics experience (mAbs and bispecifics) required; oncology and/or infectious disease strongly preferred.
- Proficiency with PK analysis/graphing tools (e.g., Phoenix WNL, Graphpad, R).
- Proven ability to manage/develop teams.
Benefits/Pay:
- Expected salary range: $235,500β$329,500/year; bonus and equity plus benefits (health/welfare plans, non-accrual paid time off, holiday shut down, commuter benefits, 401K match, lunch).
Application instructions:
- Applicants must be authorized to work in the U.S.; visa sponsorship/transfer not available.