Remote Medical Director, Clinical Research - Cardiovascular

Summary

Join Cytokinetics as a Clinical Lead to play a leading role in all aspects of product development, including clinical development planning, protocol design, data interpretation and reporting, safety monitoring, health authority interactions, and forging relationships with key opinion leaders and clinical investigators.

Requirements

• MD, MD/PhD, or DO degree with cardiology board certification by the American Board of Internal Medicine
• Significant clinical investigator experience with 6+ years in clinical development in a biotechnology or pharmaceutical company or related experience
• Experience with studies in heart failure and/or heart failure subspecialty training are strong pluses
• Proven leadership experience and strong interpersonal skills, able to motivate and drive interdisciplinary teams
• Deep scientific, clinical and research knowledge in cardiology
• Analytical and articulate in oral presentations and in writing, with a demonstrated ability to communicate effectively with colleagues at varying professional levels, especially in the medical profession
• Knowledge of CDER regulations/ICH guidelines
• Understanding of pharmaceutical safety reporting and surveillance requirements
• Computer proficiency, including Microsoft Office

Responsibilities

• Serve as clinical lead, providing medical expertise for cross-functional clinical research and development teams
• Partner with Research, Regulatory Affairs, Medical Affairs, Biometrics, Clinical Operations, Safety, Quality Assurance, Product Development, Business Development, and Management to formulate and implement comprehensive clinical development plans
• Be responsible for protocol design, medical monitoring and the clinical aspects of planning, initiation and completion of clinical trials. Author protocols and investigator brochures
• Provide strategic and medical components of IND submissions, information requests, NDA submissions, pediatric investigation plans, and other regulatory interactions. Review and contribute to other components
• Perform product safety medical reviews for investigational drugs in collaboration with safety experts
• Analyze clinical trial data, author publications and present results at medical meetings
• Establish relationships with prominent leaders and clinical investigators in cardiovascular disease
• Plan and conduct clinical advisory board meetings
• Present plans and results to senior leaders and executives
• Provide strategic input and medical expertise for decisions that have medical, scientific, and future marketing implications
• Maintain high-level scientific and medical expertise in cardiology and serve as key medical resource in the disease area
• Attend scientific meetings to maintain awareness of research activities and represent the Company at external events

Benefits

Salary pay range: $275,000 - $336,000