Medical Director, Clinical Research Cardiovascular

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.
• 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.

Qualifications

• MD or MD/PhD degree with cardiology board certification by the American Board of Internal Medicine with a minimum of 2+ years of experience in clinical development, either in a biotechnology or pharmaceutical company or as a clinical investigator, including industry-sponsored multi-center trials.
• 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.
• Ability to travel ~20% of the time.

Pay

In the U.S., the hiring pay range for fully qualified candidates is $276,120-$322,140 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.