Head of Clinical Pharmacology
Cytokinetics
August 09, 2026
Remote friendly (San Francisco Bay Area)
United States
$290,430 - $357,000 USD yearly
Clinical Research and Development
Head of Clinical Pharmacology
Key Responsibilities
- Design and provide oversight for 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 to ensure 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.
- Develop and implement clinical pharmacology strategies (FIH, SAD/MAD, food effect, DDI, QT assessment, 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.
- Drive quantitative dose justification for Phase III trials and regulatory submissions.
- Author/oversee clinical pharmacology sections of INDs, IBs, briefing documents, NDA/MAA submissions, and regulatory responses.
- Lead FDA/EMA and other global health authority interactions; provide input to labeling language for dosing, special populations, and DDIs.
- Maintain awareness of evolving regulatory guidance (FDA MIDD initiatives, ICH guidelines).
- Build/manage Clinical Pharmacology capabilities; oversee vendors/consultants; mentor scientific staff.
- Partner with Translational Medicine, Nonclinical Development, DMPK, clinical research, safety, biometrics, and CMC; provide quantitative input to benefit-risk and target product profile.
- Oversee pharmacometrics and bioanalytical CROs; contribute to publications/presentations; represent the company as needed.
Minimum Requirements
- PhD (Clinical Pharmacology, Pharmacometrics, Pharmaceutical Sciences, or related) OR MD/MD-PhD/PharmD with extensive clinical pharmacology expertise.
- 10+ years progressive industry experience in pharmaceutical/biotech drug development.
- Preferred: Pharmacometrics experience; demonstrated PK/PD modeling, population PK, exposure-response analysis, and simulation.
- Proven dose selection/justification for pivotal trials and regulatory submissions.
- Strong understanding of ICH, GCP, and global regulatory frameworks.
- Experience interacting with FDA, PMDA, and EMA regarding clinical pharmacology strategy.
- Experience in cardiovascular, neuromuscular, or related therapeutic areas is a plus.
Key Responsibilities
- Design and provide oversight for 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 to ensure 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.
- Develop and implement clinical pharmacology strategies (FIH, SAD/MAD, food effect, DDI, QT assessment, 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.
- Drive quantitative dose justification for Phase III trials and regulatory submissions.
- Author/oversee clinical pharmacology sections of INDs, IBs, briefing documents, NDA/MAA submissions, and regulatory responses.
- Lead FDA/EMA and other global health authority interactions; provide input to labeling language for dosing, special populations, and DDIs.
- Maintain awareness of evolving regulatory guidance (FDA MIDD initiatives, ICH guidelines).
- Build/manage Clinical Pharmacology capabilities; oversee vendors/consultants; mentor scientific staff.
- Partner with Translational Medicine, Nonclinical Development, DMPK, clinical research, safety, biometrics, and CMC; provide quantitative input to benefit-risk and target product profile.
- Oversee pharmacometrics and bioanalytical CROs; contribute to publications/presentations; represent the company as needed.
Minimum Requirements
- PhD (Clinical Pharmacology, Pharmacometrics, Pharmaceutical Sciences, or related) OR MD/MD-PhD/PharmD with extensive clinical pharmacology expertise.
- 10+ years progressive industry experience in pharmaceutical/biotech drug development.
- Preferred: Pharmacometrics experience; demonstrated PK/PD modeling, population PK, exposure-response analysis, and simulation.
- Proven dose selection/justification for pivotal trials and regulatory submissions.
- Strong understanding of ICH, GCP, and global regulatory frameworks.
- Experience interacting with FDA, PMDA, and EMA regarding clinical pharmacology strategy.
- Experience in cardiovascular, neuromuscular, or related therapeutic areas is a plus.