Medical Director - Clinical Development
Proclinical is currently recruiting for a Medical Director of Clinical Research for a biopharmaceutical company located in Rockville, Maryland. Successful candidate will be given the chance to influence Global strategic goals and become an integral member of a highly anticipated project build.
- Design study protocols and clinical development plans in collaboration with different function teams in US and China for oncology or autoimmune therapeutic areas.
- Author key clinical sections of IB, IND sections, regulatory briefing books, Annual Reports, CSR as well as prepare strategy presentations, present and discuss data with governance, external consultants, KOLs and potentially within regulatory meetings in conjunction with members of the development team.
- Create and/or review study documents/plans including monitoring plan, data management plan, safety review plan, etc.
- Performing ongoing data reviews, and leadership of safety review meetings.
- Communicate internally and externally (oral and written communication) on clinical trial design and results.
- Analyze and synthesize clinical data for publication, conducting and evaluating clinical trials.
- Proactively identify clinical development risks and propose risk mitigations.
- Supervise project team members in planning conducting and evaluating clinical trials.
- Serve as medical monitor with significant responsibility for safety surveillance.
- Collaborate with R&D and other senior management in assessing requirements for emerging products, including next generation candidates.
- Identify, select and train clinical research centers and investigators.
- Overseas planning and management of investigator meetings, advisory boards and other scientific committees as required by the protocol (e.g. independent reviews, DSMB's etc.).
- Participate in the selection of sites, CROs, and vendors.
Skills and Requirements:
- MD with 2-5 years of experience within a pharmaceutical company environment required.
- Working knowledge of medical, scientific and clinical research in the oncology and autoimmune therapeutic areas.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call James Stevens at (+1) 646-693-0610 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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