Head of Clinical Pharmacology
Cytokinetics
June 27, 2026
Remote
United States
$290,430 - $357,000 USD yearly
Clinical Research and Development
Head of Clinical Pharmacology (Reporting to Chief Medical Officer)
Responsibilities:
- Design and oversee Phase I and early Phase II studies (including adaptive dose escalation); ensure PK sampling and bioanalytical plans.
- Interpret emerging safety, PK, and PD data to guide dose escalation and program advancement; lead dose selection rationale for FIH, Phase II, and Phase III trials.
- Develop clinical pharmacology strategies (FIH, SAD/MAD, food effect, DDI, QT, renal/hepatic impairment, intrinsic/extrinsic factors, special populations).
- Lead model-informed drug development (MIDD); oversee population PK, exposure-response modeling, covariate analyses, simulations, and scenario planning.
- Author/oversee IND/IB and NDA/MAA clinical pharmacology sections; support FDA/EMA/global regulatory interactions; respond to regulatory queries.
- Provide strategic input to labeling (dosing, special populations, DDIs).
- Build/managing clinical pharmacology capabilities; oversee vendors/CROs; mentor staff; represent as expert externally as needed.
Minimum requirements:
- PhD (Clinical Pharmacology/Pharmacometrics/Pharmaceutical Sciences or related) OR MD/MD-PhD/PharmD with extensive clinical pharmacology expertise.
- 10+ years industry experience in pharmaceutical/biotech drug development.
- Demonstrated PK/PD modeling, population PK, exposure-response analysis, and simulation; dose selection/justification for pivotal trials and regulatory submissions.
- Experience interacting with FDA, PMDA, and EMA; strong ICH/GCP/global regulatory understanding.
Preferred:
- Pharmacometrics experience; direct NDA/MAA clinical pharmacology contribution/lead; cardiovascular/neuromuscular therapeutic experience.
Pay range (U.S.): $290,430.00–$357,000.00/year.
Application instruction: Review the GDPR policy prior to applying.
Responsibilities:
- Design and oversee Phase I and early Phase II studies (including adaptive dose escalation); ensure PK sampling and bioanalytical plans.
- Interpret emerging safety, PK, and PD data to guide dose escalation and program advancement; lead dose selection rationale for FIH, Phase II, and Phase III trials.
- Develop clinical pharmacology strategies (FIH, SAD/MAD, food effect, DDI, QT, renal/hepatic impairment, intrinsic/extrinsic factors, special populations).
- Lead model-informed drug development (MIDD); oversee population PK, exposure-response modeling, covariate analyses, simulations, and scenario planning.
- Author/oversee IND/IB and NDA/MAA clinical pharmacology sections; support FDA/EMA/global regulatory interactions; respond to regulatory queries.
- Provide strategic input to labeling (dosing, special populations, DDIs).
- Build/managing clinical pharmacology capabilities; oversee vendors/CROs; mentor staff; represent as expert externally as needed.
Minimum requirements:
- PhD (Clinical Pharmacology/Pharmacometrics/Pharmaceutical Sciences or related) OR MD/MD-PhD/PharmD with extensive clinical pharmacology expertise.
- 10+ years industry experience in pharmaceutical/biotech drug development.
- Demonstrated PK/PD modeling, population PK, exposure-response analysis, and simulation; dose selection/justification for pivotal trials and regulatory submissions.
- Experience interacting with FDA, PMDA, and EMA; strong ICH/GCP/global regulatory understanding.
Preferred:
- Pharmacometrics experience; direct NDA/MAA clinical pharmacology contribution/lead; cardiovascular/neuromuscular therapeutic experience.
Pay range (U.S.): $290,430.00–$357,000.00/year.
Application instruction: Review the GDPR policy prior to applying.