VP Clinical Development – Rare and Orphan Diseases
VP Clinical Development for a small clinical-stage pharma company in Los Angeles San Fernando Valley. Candidate needs to have a MD, be experienced in rare and orphan disease studies and have significant experience clinical trials.
- M.D. or D.O. with specialty training, preferably CNS diseases
- 10 -15 years of progressive experience through all the phases of drug development would be ideal
- Management of clinical trials (Phases 1 – 3)
- Experience in orphan and rare diseases, pediatrics and/or neurology preferred
Roles and Responsibilities
- Responsible for the design and reporting of clinical trials that meet the standards of excellence for ethics, scientific merit, and regulatory compliance, as well as satisfy corporate goals for approval of products.
- Act as medical director on selected product development candidate programs. This includes designing clinical trials and an overall clinical development strategy leading to global product registration.
- Interpret results of Phases 1 – 3 clinical investigations in preparation for new drug applications to relevant regulatory authorities.
- Develop, draft and/or review clinical study reports and manage the presentation of key clinical findings to internal and external constituents.
- Provide clinical development support for company activities and manage physician consultants and collaborators in the clinical research program.
- Contribute in an active and ongoing manner to the scientific, clinical and commercial development of current and future product candidates (internally and externally developed).
- Help represent the company as needed as a senior medical spokesperson to a variety of scientific, business and government groups/agencies.
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