Executive Director, Clinical Development- Cardiometabolic Center of Excellence
The Executive Director, Clinical Development, Cardiometabolic Center of Excellence assumes overall responsibility for the company’s activities within drug development and safety.
Late last year this organization opened a joint research institution in Boston, Massachusetts where company researchers and scientists from Brigham and Women's Hospital, an affiliate of Harvard Medical School, conduct joint research on discovery and development in the field of cardiometabolic diseases.
Principal Duties and Responsibilities:
- Plans and directs all aspects of medical policies and programs.
- Ensures all clinical programs are in compliance and are executed expeditiously.
- Oversees pharmacovigilance/risk management processes for investigational products.
- Oversees project management, clinical operations, and pharmacovigilance staff for clinical development programs.
- Provides input to HQ and its affiliates about the company’s drug development portfolio and about study design of new clinical trials.
- Provides medical expertise for business development/licensing staff.
- Provides medical expertise for regulatory affairs staff.
- Provides medical expertise for Quality Affairs staff.
- Responsible for all safety and medical monitoring of trials, review and submission of expedited safety reports to the FDA in conjunction with Regulatory Affairs or with relevant staff of a CRO if that responsibility has been transferred, review of non-expedited safety reports, and review of analysis of similar events as appropriate.
- Reviews scientific publications and scientific meeting presentations produced by staff and affiliate offices, and collaborative entities including physicians and co-marketing partners.
- Responsible for strategic clinical relationships with Advisory Board Members, Data Safety Monitoring Boards, and other relevant external physician and scientific consultants.
- Writes research publications appropriate to support clinical and business activities.
- Ensures that clinical studies are conducted in compliance with protocol, GCP, FDA and foreign Regulatory Authority regulations, as appropriate, as well as company policies and procedures.
- Develops and presents scientific material on investigational drugs to internal and external audiences.
- Performs a variety of other tasks. Leads and directs the work of others.
Knowledge and Skills:
- MD with at least 5 years of relevant medical and pharmaceutical experience.
- Participation in the submission of at least 2 INDs.
- The ability to establish and maintain effective relationships with other management staff, employees, affiliates, and the general public.
- The ability to present facts and recommendations effectively in oral and written form.
- Thorough understanding of GCPs, FDA and ICH guidelines,
- Excellent written and oral communication skills
- A detail-oriented work style and the ability to handle multiple tasks