Head of Drug Development (BME)
Job Location: Morristown, NJ
This hands-on position manages the drug development team, reports directly to the President, and is responsible for oversight of all R&D activities, including but not limited to the following core responsibilities: Serves as Head of Drug Development for all US-based projects and operations by leading the Scientific and Regulatory Affairs and Clinical Development. Oversees all functions of all studies in clinical development (predominantly Phase I and II). Directs and executes high-level clinical development programs and clinical development plan for products in the Company’s early phase development portfolio. Prepares various official and regulatory documents for Regulatory and other agencies, such as Dossiers, BLAs, INDs, Safety and Annual reports, handling of responses to regulatory agencies regarding questions about complex clinical development issues (e.g., safety or efficacy). Oversees and shapes the design and implementation of clinical research programs to support regulatory needs, including the submission of INDs, development of Clinical Development Plans (CDP), investigator brochures (IB), annual safety reports (DSUR), etc. Works with executive management both in the U.S. and HQ in Japan to lend clinical study plan consultation about Company's drug development and then promoting the Company’s drug development plan, as finalized by HQ, to external partners (KOL’s, CRO’s, etc.) on behalf of HQ. Collaborates with preclinical laboratories (toxicology, ADME, pharmacology and CMC) and clinical pharma teams at HQ and provides scientific, developmental and clinical expertise to the team. Develops a strongly aligned team that interacts efficiently and professionally with investigators, site research personnel, scientists, CROs and other internal & external parties supporting clinical development. Plans and chairs scientific advisory committee meetings with industry-leading experts and consultants. Manages all external partner and vendor relationships (i.e. CROs, medical advisor, key opinion doctor, regulatory affairs consultant, etc.). Manages and evaluates non clinical and clinical study data, including safety. Ensures all components are in place for QC and QA in accordance with ICH GCP standards. Works with executive management both in the U.S. and HQ in Japan to design clinical trials that support the objectives for each compound. Oversees the drug development (regulatory/scientific) affairs function, including managing internal staff and external partnerships.
PhD degree in related field required; related advanced degree (MD) a plus. Minimum of 15 years of relevant industry experience required. Solid understanding of and hands on experience with Phase I and Phase II drug development required. Clinical experience in any of the fields of Psychiatry (Schizophrenia, MDD etc.) is strongly preferred. Supervisory experience strongly desired. Travel up to 25%.
Please contact Bill Emker at email@example.com
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