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MK15237 - MEDICAL DIRECTOR, CLINICAL AFFAIRS
The Medical Director, Clinical Affairs is responsible for global oversight and strategy for the clinical affairs aspects of the brand.
Main responsibilities: Liaising within the company infrastructure as well as national and international partners, to facilitate and foster scientific exchange and development within the international community. Strategic planning of clinical affairs functions. Work in collaboration with the life cycle team leader to develop strategic plans, in collaboration with all international partners, and in consideration of all ongoing and planned registration activities. Oversee competitive intelligence efforts. Continually develop relationships within therapeutic discipline. Team development and ongoing training of the specialty field staff in North America. Strategic planning and management of mature, dynamic, and expanding Investigator Initiated Study program. Strategic planning and operational implementation of robust Publication Plan (30 publications, 15 abstracts, 5 oral presentations). Primary liaison to international partners for clinical affairs functions. Expert support to specialty field staff, internal infrastructure and associated vendors. Primary liaison to national/international regulatory agencies for brand. Liaison to international KOL, thought leaders, cooperative and working groups in HSCT Clinical oversight of pharmacokinetic program. Strategic planning and operational initiation of IND programs to explore expansion of product labeling. Participate, as needed, in review of new product acquisitions.
Required Skills:
MD, – Oncology with 2-3 yrs experience in the pharmaceutical industry or in working with clinical trials in oncology. Must have working knowledge of hematopoietic stem cell transplantation. Knowledge of US and OUS requirements for conduct of clinical trials and knowledge of ICH guidelines. Excellent oral, written communication and interpersonal skills.
The successful candidate will also have knowledge of effective competitive strategies as well as an in-depth understanding of clinical product development in the pharmaceutical industry. High analytical skills, especially with regard to understanding and interpreting scientific research and literature are essential. Ability to anticipate industry trends, emerging issues and competitive strategy is essential, as is the appreciation of the complexities of cross-functional management issues.
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