Associate Director, Clinical Pharmacology
Crinetics Pharmaceuticals
9 hours ago
Remote friendly (United States)
United States
$166,000 - $208,000 USD yearly
Clinical Research and Development
Associate Director, Clinical Pharmacology
Responsibilities:
- Develop clinical pharmacology strategy aligned to TPP/CDP and US/international guidance for small molecules.
- Partner with DMPK and Clinical Research to define biopharmaceutics and clinical PK/PD studies supporting NDA/label.
- Design, plan, and analyze Phase 1–4 PK/PD studies.
- Lead model-informed drug development (MIDD) and partner with pharmacometrics to develop population PK/PK-PD models for development/regulatory decisions.
- Plan, prepare, and review drug development plans and regulatory filings.
- Provide clinical pharmacology expertise across cross-functional teams (Clinical Ops, Clinical Research, Biometrics, Bioanalysis).
- Design Phase 1 studies (e.g., DDI, bioavailability/bioequivalence, special populations).
- Select Phase 1 CROs.
- Analyze/interpret PK and PK/PD data.
- Support clinical protocol/report preparation.
- Author/regulate clinical pharmacology sections (IND, IMPD, IB, NDA CTD), respond to RFIs, and support publications/presentations.
Qualifications:
- Pharm.D./Ph.D. or MS in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, Chemistry, Biochemistry, Engineering, or related field.
- 8+ years industry experience in clinical pharmacology study conduct/oversight and data analysis.
- Experience preparing Clinical Pharmacology sections for IND- and NDA-stage submissions.
- Demonstrated ability to independently develop clinical pharmacology strategy and design PK/PK-PD characterization studies.
- Preferred: FIH and/or Phase II/III dose selection, pediatric dose selection, DDI, metabolism enzymology, formulation bridging, bioequivalence, food-effect, exposure-QTc, special populations, radiolabeled mass balance.
- Experience preparing IND/CTA/NDA/MAA.
- Cross-functional/matrix experience.
- Proficient with PK/PK-PD software (e.g., Phoenix) and demonstrated MIDD application.
- Strong communication skills.
Benefits (as stated):
- Salary range: $166,000–$208,000.
- Discretionary annual target bonus, stock options, ESPP, 401k match; medical/dental/vision/basic life; 20 PTO days; 10 paid holidays; winter company shutdown.
Responsibilities:
- Develop clinical pharmacology strategy aligned to TPP/CDP and US/international guidance for small molecules.
- Partner with DMPK and Clinical Research to define biopharmaceutics and clinical PK/PD studies supporting NDA/label.
- Design, plan, and analyze Phase 1–4 PK/PD studies.
- Lead model-informed drug development (MIDD) and partner with pharmacometrics to develop population PK/PK-PD models for development/regulatory decisions.
- Plan, prepare, and review drug development plans and regulatory filings.
- Provide clinical pharmacology expertise across cross-functional teams (Clinical Ops, Clinical Research, Biometrics, Bioanalysis).
- Design Phase 1 studies (e.g., DDI, bioavailability/bioequivalence, special populations).
- Select Phase 1 CROs.
- Analyze/interpret PK and PK/PD data.
- Support clinical protocol/report preparation.
- Author/regulate clinical pharmacology sections (IND, IMPD, IB, NDA CTD), respond to RFIs, and support publications/presentations.
Qualifications:
- Pharm.D./Ph.D. or MS in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, Chemistry, Biochemistry, Engineering, or related field.
- 8+ years industry experience in clinical pharmacology study conduct/oversight and data analysis.
- Experience preparing Clinical Pharmacology sections for IND- and NDA-stage submissions.
- Demonstrated ability to independently develop clinical pharmacology strategy and design PK/PK-PD characterization studies.
- Preferred: FIH and/or Phase II/III dose selection, pediatric dose selection, DDI, metabolism enzymology, formulation bridging, bioequivalence, food-effect, exposure-QTc, special populations, radiolabeled mass balance.
- Experience preparing IND/CTA/NDA/MAA.
- Cross-functional/matrix experience.
- Proficient with PK/PK-PD software (e.g., Phoenix) and demonstrated MIDD application.
- Strong communication skills.
Benefits (as stated):
- Salary range: $166,000–$208,000.
- Discretionary annual target bonus, stock options, ESPP, 401k match; medical/dental/vision/basic life; 20 PTO days; 10 paid holidays; winter company shutdown.