Head of Clinical Pharmacology

Cytokineticsis 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.

Cytokinetics is seeking a Head of Clinical Pharmacology to provide strategic leadership for clinical pharmacology and model-informed drug development across our portfolio. Reporting to the Chief Medical Officer this individual will lead the development and execution of integrated clinical pharmacology strategies from First-in-Human through registration and lifecycle management.

The Head of Clinical Pharmacology will serve as the subject matter expert for clinical pharmacology pharmacokinetics (PK) pharmacodynamics (PD) PK/PD modeling and simulation PBPK modeling metabolic profiling and exposure-response analyses ensuring robust dose selection characterization of drug-drug interaction profiles and regulatory alignment. This role requires deep expertise in translational science pharmacometrics and global regulatory requirement in late-stage development.

While this position is headquartered in South San Francisco CA we are open to highly qualified candidates working remotely across the United States.

Key Responsibilities

Study Design & Execution

• 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.

Clinical Pharmacology Strategy

• Develop and implement comprehensive clinical pharmacology strategies spanning FIH SAD/MAD food effect drug-drug interaction (DDI) QT assessment renal/hepatic impairment intrinsic/extrinsic factor studies and special populations.

• Lead model-informed drug development (MIDD) approaches integrating nonclinical translational and clinical data to support rational dose selection and optimization.

• Oversee population PK analyses exposure-response modeling covariate analyses simulations and scenario planning to inform development decisions.

• Drive quantitative dose justification for Phase III trials and regulatory submissions.

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.

Team Leadership and Management

• Build and manage internal Clinical Pharmacology capabilities.

• Oversee external vendors and consultants.

• Mentor and develop scientific staff.

Cross-Functional & 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.

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.

Minimum 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.

• Pharmacometrics experience preferred; 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.

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

Pay Range:

Our employees come from different backgrounds and we celebrate those differences. We are looking for the best candidates for our open roles but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team we would love to hear from you.

Please review ourGeneral Data Protection Regulation (GDPR) policyPRIOR to applying.

Our passion is anchored in robust scientific thinking grounded in integrity and critical thinking. We keep the patient front and center in all we do all actions and decisions are in service of the patient and their caregivers. We champion integrity ethics doing the right thing and being our best selves.

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Cytokinetics is an Equal Opportunity Employer