Head of Clinical Pharmacology
Cytokinetics
August 31, 2026
Remote friendly (San Francisco Bay Area)
United States
$290,430 - $357,000 USD yearly
Clinical Research and Development
Key Responsibilities
Study Design & Execution
- Design and oversee Phase I and early Phase II studies, including adaptive dose escalation strategies.
- Ensure PK sampling strategies and bioanalytical plans.
- Collaborate with Clinical Operations and Biostatistics for high-quality data collection and analysis.
- 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.
Clinical Pharmacology Strategy
- Develop clinical pharmacology strategies across FIH, SAD/MAD, food effect, DDI, QT assessment, renal/hepatic impairment, intrinsic/extrinsic factor studies, and special populations.
- Lead model-informed drug development (MIDD) to support rational dose selection and optimization.
- Oversee population PK analyses, exposure-response modeling, covariate analyses, simulations, and scenario planning.
- Drive quantitative dose justification for Phase III trials and regulatory submissions.
Regulatory Leadership
- Author/oversee clinical pharmacology sections of INDs, IBs, briefing documents, NDA/MAA submissions, and responses to regulatory queries.
- Lead clinical pharmacology preparation for FDA, EMA, and other global health authority interactions.
- Provide input to labeling language for dosing, special populations, and DDIs.
- Maintain knowledge of evolving regulatory guidance (including FDA MIDD and ICH).
Team Leadership & Integration
- Build/manage Clinical Pharmacology capabilities; oversee vendors/consultants; mentor scientific staff.
- Partner with Translational Medicine, Nonclinical Development, DMPK, clinical research, drug safety, biometrics, and CMC.
- Serve on cross-functional program teams and governance committees.
Minimum Requirements
- PhD (Clinical Pharmacology/Pharmacometrics/Pharmaceutical Sciences or related quantitative) or MD/MD-PhD/PharmD with extensive clinical pharmacology expertise.
- 10+ years progressive industry experience.
- Pharmacometrics preferred; strong PK/PD modeling, population PK, exposure-response, and simulation.
- Proven dose selection/justification for pivotal trials and regulatory submissions.
- NDA/MAA clinical pharmacology leadership/experience strongly preferred.
- Experience with FDA, PMDA, EMA; strong ICH/GCP/global regulatory knowledge.
- Cardiovascular/neuromuscular therapeutic area experience is a plus.
Pay Range (U.S.)
- $290,430.00 - $357,000.00/year.
Study Design & Execution
- Design and oversee Phase I and early Phase II studies, including adaptive dose escalation strategies.
- Ensure PK sampling strategies and bioanalytical plans.
- Collaborate with Clinical Operations and Biostatistics for high-quality data collection and analysis.
- 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.
Clinical Pharmacology Strategy
- Develop clinical pharmacology strategies across FIH, SAD/MAD, food effect, DDI, QT assessment, renal/hepatic impairment, intrinsic/extrinsic factor studies, and special populations.
- Lead model-informed drug development (MIDD) to support rational dose selection and optimization.
- Oversee population PK analyses, exposure-response modeling, covariate analyses, simulations, and scenario planning.
- Drive quantitative dose justification for Phase III trials and regulatory submissions.
Regulatory Leadership
- Author/oversee clinical pharmacology sections of INDs, IBs, briefing documents, NDA/MAA submissions, and responses to regulatory queries.
- Lead clinical pharmacology preparation for FDA, EMA, and other global health authority interactions.
- Provide input to labeling language for dosing, special populations, and DDIs.
- Maintain knowledge of evolving regulatory guidance (including FDA MIDD and ICH).
Team Leadership & Integration
- Build/manage Clinical Pharmacology capabilities; oversee vendors/consultants; mentor scientific staff.
- Partner with Translational Medicine, Nonclinical Development, DMPK, clinical research, drug safety, biometrics, and CMC.
- Serve on cross-functional program teams and governance committees.
Minimum Requirements
- PhD (Clinical Pharmacology/Pharmacometrics/Pharmaceutical Sciences or related quantitative) or MD/MD-PhD/PharmD with extensive clinical pharmacology expertise.
- 10+ years progressive industry experience.
- Pharmacometrics preferred; strong PK/PD modeling, population PK, exposure-response, and simulation.
- Proven dose selection/justification for pivotal trials and regulatory submissions.
- NDA/MAA clinical pharmacology leadership/experience strongly preferred.
- Experience with FDA, PMDA, EMA; strong ICH/GCP/global regulatory knowledge.
- Cardiovascular/neuromuscular therapeutic area experience is a plus.
Pay Range (U.S.)
- $290,430.00 - $357,000.00/year.