(Associate) Medical Director, Cardiology
California, USA
The PositionThe Associate Medical Director/Medical Director will be under the supervision of the head of cardiometabolic clinical development and will play a crucial role in introducing significant new therapies leveraging RNA interference to patients. This individual will collaborate closely with our client's scientific and clinical teams to advance drugs from late clinical research to NDA filings, with an initial emphasis on siRNA programs targeting cardiac and metabolic (lipids and obesity) indications. While experience in these fields is preferred, it is not mandatory. They will assume direct responsibility for designing and overseeing clinical studies to assess the efficacy, safety, dose selection, and clinical pharmacology of product candidates. Candidates with appropriate experience may be considered for the Medical Director position.
Responsibilities
Support the conceptualization, design, development, execution, and communication of clinical studies across various therapeutic areas.
Serve as the medical lead in a cross-functional team comprising medical, scientific, clinical, safety, program management, and regulatory personnel.
Effectively convey protocols and other pertinent information to clinical site investigators and staff.
Interpret clinical trial data and communicate results clearly and accurately.
Conduct ongoing clinical monitoring for trials, including assessing eligibility criteria, managing toxicity, and overseeing drug safety surveillance.
Contribute to various documents, such as IRB submissions, protocols, study reports, publications, and regulatory filings, including forthcoming NDA/MAA submissions.
Provide high-level and intricate scientific and clinical guidance to Clinical Trials Management, Biometrics, Global Drug Safety, Regulatory, and Project Management teams to ensure project deliverables and timelines are met. • Identify key opinion leaders and participate in clinical advisory board meetings.
Deliver scientific presentations at advisory boards, major scientific gatherings, and external committee meetings.
Identify and evaluate medical needs and clinical pathways for new applications of RNA interference in disease treatment.
Stay abreast of emerging developments in RNA interference in both industry and academia.
Support activities related to in-licensing, out-licensing, and partnership relationships.
Requirements:
M.D., or Ph.D./M.D. combined with research experience
A strong desire to contribute to the development of meaningful therapeutics
Ability to effectively evaluate outside expert advice
Ability to clearly elucidate complex scientific and medical concepts via written and oral communication
Ability to work independently and effectively in a fast-paced, team-based, cross-functional environment
Strong interpersonal skills and the ability to communicate effectively with people in diverse and different settings
Excellent scientific communication skills (both verbal and technical) and interpersonal skills
Possesses sense of urgency without overlooking key details; identifies challenges and problems and takes the initiative to identify solutions
Results focused
Willingness to relocate if necessary to either Pasadena or San Diego, CA
Preferred:
Hands-on clinical research experience within a pharmaceutical or biotechnology company or in an academic setting
Fellowship training in relevant specialty (eg cardiology, endocrinology)