Associate Medical Director, Clinical Research Cardiovascular

📋 Description

• • Serve as the primary medical authority across the entire life-cycle of cardiovascular clinical trials, from first-in-human Phase I through pivotal Phase III and eventual NDA submission. You will translate complex muscle-biology science into patient-centric protocols that advance Cytokinetics’ 25-year legacy of pioneering cardiac therapeutics.
• • Provide strategic medical leadership to cross-functional project teams—Research, Regulatory Affairs, Medical Affairs, Biometrics, Clinical Operations, Safety, QA, Product Development, Business Development, and senior management—ensuring that every decision balances scientific rigor, regulatory compliance, and patient safety.
• • Design, author, and critically review the medical components of study protocols, investigator brochures, IND safety updates, clinical study reports, and regulatory briefing documents. Your clinical acumen will directly shape dose selection, endpoint definitions, inclusion/exclusion criteria, and risk-mitigation strategies.
• • Act as the named medical monitor for multiple concurrent trials, safeguarding patient safety through real-time safety data review, SAE adjudication, and proactive risk management. You will be the go-to physician for sites, CRAs, and internal stakeholders when medical questions arise.
• • Build and nurture relationships with world-renowned cardiologists and heart-failure specialists, serving as the scientific face of Cytokinetics at advisory boards, steering committees, and major congresses (AHA, ACC, HFSA). Your credibility will accelerate site recruitment, data quality, and external advocacy.
• • Partner with biostatistics and clinical operations to craft adaptive trial designs, master protocols, and innovative digital endpoints that reduce patient burden while maximizing statistical power. You will interpret interim analyses and recommend dose escalations, cohort expansions, or study modifications.
• • Lead cross-functional safety review committees, synthesizing data from pre-clinical toxicology, early-phase human studies, and post-marketing surveillance to maintain an up-to-date benefit-risk assessment for each investigational product.
• • Contribute to regulatory strategy and health-authority interactions (FDA, EMA, PMDA), presenting clinical data, responding to questions, and negotiating labeling language. Your insights will directly influence approval timelines and post-marketing commitments.
• • Mentor junior physicians and clinical scientists, fostering a culture of scientific curiosity, ethical integrity, and patient advocacy. You will champion diversity in clinical trial enrollment and ensure that protocols address under-represented populations.
• • Stay at the forefront of cardiovascular science by monitoring competitive pipelines, real-world evidence, and emerging digital-health technologies. You will translate external insights into internal strategy, ensuring Cytokinetics remains the leader in muscle-activation therapeutics.
• • Uphold Cytokinetics’ core values: robust scientific thinking, unwavering integrity, and patient-first decision-making. Every protocol amendment, safety review, and regulatory interaction will reflect these principles.
• • Operate effectively in a fully remote environment while maintaining seamless collaboration across time zones. You will leverage digital tools to conduct virtual site visits, remote data reviews, and real-time team huddles without compromising scientific rigor or regulatory compliance.