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.
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.
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.
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 candidates geographic region, job-related knowledge, skills, and experience among other factors.
Equal Opportunity Employer
Cytokinetics is an Equal Opportunity Employer. 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.
Fraud Warning
Recently, there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain (Cytokinetics.com) and will only be made after completing a formal interview process.
Here are some ways to check for authenticity:
- 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
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Please visit our website at: www.cytokinetics.com