Head of Clinical Pharmacology

About the role

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. At Cytokinetics, each team member plays an integral part in advancing our mission to improve the lives of patients. We are seeking tenacious, compassionate, and collaborative individuals who are driven to make a positive impact.

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.

Requirements

• PhD in Clinical Pharmacology, Pharmacometrics, Pharmaceutical Sciences, or related quantitative discipline; or MD, MD/PhD, or PharmD with extensive clinical pharmacology expertise.
• 10+ years of progressive industry experience in pharmaceutical or biotechnology drug development.
• Demonstrated expertise in PK/PD modeling, population PK, exposure-response analysis, and simulation methodologies.
• Proven experience supporting dose selection and justification for pivotal trials and regulatory submissions.
• Direct experience contributing to or leading clinical pharmacology components of NDA/MAA filings strongly preferred.
• Experience interacting with FDA, PMDA, and EMA regarding clinical pharmacology strategy.
• Strong understanding of ICH, GCP, and global regulatory frameworks.

Qualifications

• Experience in cardiovascular, neuromuscular, or related therapeutic areas is a plus.

Skills

• Deep expertise in translational science, pharmacometrics, and global regulatory requirements.
• Strategic leadership in clinical pharmacology and model-informed drug development.
• Strong understanding of regulatory guidance, including FDA MIDD initiatives and ICH guidelines.
• Ability to partner with cross-functional teams and contribute to scientific publications and external presentations.

Benefits

At Cytokinetics, we are committed to providing a competitive compensation package. The base pay range for fully qualified candidates in the U.S. is $290,430.00 - $357,000.00 per year. The actual offer will take into account internal equity and other factors.

Pay

In the U.S., the hiring pay range for fully qualified candidates is $290,430.00 - $357,000.00 per year.

Schedule

The position is based in South San Francisco, CA, with remote options available for highly qualified candidates across the United States.

External Collaboration & Scientific Leadership

Oversee pharmacometric and bioanalytical CROs and consultants. Contribute to scientific publications and external presentations as appropriate. Represent Cytokinetics externally as a clinical pharmacology expert when required.

Team Leadership and Management

Build and manage internal Clinical Pharmacology capabilities. Oversee external vendors and consultants. Mentor and develop scientific staff.

Translational Integration

Partner closely with Translational Medicine, Nonclinical Development, and DMPK to ensure seamless integration of exposure-response relationships and biomarker strategy. Collaborate with clinical research, drug safety, and biometrics on protocol development and data analyses. Partner with CMC on formulation and bioavailability strategy. Provide quantitative input into benefit-risk assessment and target product profile refinement. Serve as a core member of cross-functional program teams and governance committees.

Regulatory Leadership

Author and 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 strategic input into labeling language related to dosing, special populations, and DDIs. Maintain current knowledge of evolving regulatory guidance, including FDA MIDD initiatives and ICH guidelines.

General Data Protection Regulation (GDPR)

Please review our GDPR policy PRIOR to applying.

Fraud Warning

We do not conduct job interviews through non-standard text messaging applications. We will never request personal information such as banking details until after an official offer has been accepted and verified. We will never request that you purchase equipment or other items when interviewing or hiring. If you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at talentacquisition@cytokinetics.com. Please visit our website at: www.cytokinetics.com