Cytokinetics
Head of Clinical Pharmacology
South San Francisco, California · Exec
Sponsorship not specified$290k-$357kDetected 31 days ago
GCPComplianceClinical TrialsClinical ResearchPharmacologyFDA RegulatoryPharmacovigilanceResearchExperimental DesignLeadershipCommunicationCollaborationPublic SpeakingBiostatistics
About the role
- Cytokinetics is seeking a Head of Clinical Pharmacology to provide strategic leadership for clinical pharmacology and model-informed drug development across our portfolio.
- This role requires deep expertise in translational science, pharmacometrics, and global regulatory requirement in late-stage development.
- The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors.
Responsibilities
- Study Design & Execution
- Design and provide oversight for Phase I and early Phase II studies, including adaptive dose escalation strategies.
- Collaborate with Clinical Operations and Biostatistics to ensure high-quality data collection and analysis.
- Lead dose selection rationale for FIH, Phase II, and Phase III trials.
- 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.
- Drive quantitative dose justification for Phase III trials and regulatory submissions.
- Author and oversee clinical pharmacology sections of INDs, IBs, briefing documents, NDA/MAA submissions, and responses to regulatory queries.
- Maintain current knowledge of evolving regulatory guidance, including FDA MIDD initiatives and ICH guidelines.
- Build and manage internal Clinical Pharmacology capabilities.
Requirements
- or MD, MD/PhD, or PharmD with extensive clinical pharmacology expertise.
- 10+ years of progressive industry experience in pharmaceutical or biotechnology drug development.
- Proven experience supporting dose selection and justification for pivotal trials and regulatory submissions.
- Experience interacting with FDA, PMDA, and EMA regarding clinical pharmacology strategy.
- Strong understanding of ICH, GCP, and global regulatory frameworks.
- Represent Cytokinetics externally as a clinical pharmacology expert when required.
Nice to have
- Pharmacometrics experience preferred
- Demonstrated expertise in PK/PD modeling, population PK, exposure-response analysis, and simulation methodologies.
- Direct experience contributing to or leading clinical pharmacology components of NDA/MAA filings strongly preferred.
- Experience in cardiovascular, neuromuscular, or related therapeutic areas is a plus.
Compensation
- In the U.S., the hiring pay range for fully qualified candidates is $290,430.00 - $357,000.00 per year.
- The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors.
Benefits
- Lead clinical pharmacology preparation for FDA, EMA, and other global health authority interactions.
- Provide quantitative input into benefit-risk assessment and target product profile refinement.
Equal opportunity
- www.cytokinetics.com
- Cytokinetics is an Equal Opportunity Employer
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