The individual will 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. The individual will also partner with members of the new product planning group to assist with market research, defining the target product profile, and health economics and outcomes research, as well as serving as a consultant to evaluate new projects in research and outside licensing opportunities.
In sum, the position will support future INDs, Phase I-III studies and NDA submissions and collaborate with medical affairs and commercial colleagues on launch strategy and life cycle management.
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.
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Pay Range: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.
