Oncology Director, Medical Research Job at Daiichi Sankyo – Parsippany, NJ
We are currently seeking a Director, Medical Research, Oncology for our Parsippany, New Jersey location. This position sets strategies in alignment with leadership, internal and external partners to maximize portfolio and brand needs for oncology. This role is the point of contact for Investigator Initiated Studies (IISs). You will be the strategic partner with colleagues in New Product Planning, brand teams, Clinical Development (CD), Health Economics Outcomes Research, Professional Affairs and Advertising Review Committee.
You will play a strategic role in designing clinical trials with CD to achieve patient/commercial needs while meeting all regulatory Requirements; and preparation of regulatory documents and responses to questions from regulatory authorities.
Responsibilities:
In this role, you will be the strategic lead for advisory meetings that enhance the brands medical contribution to patient care; provide guidance in the preparation of phase I/ II/III/ IV clinical trial protocols and clinical trial reports; and lead and review all IISs for clinical and functional appropriateness for the therapeutic area. Additionally, you will provide strategic plans, working closely with head of MA-Oncology therapeutic area, for Clinical Development Plan ensuring that medical and commercial needs and all regulatory requirements are met. You will also set strategies in alignment with leadership, brand, extended medical team to ensure timely release of data supporting core development areas and assure high quality outputs and participate as a reviewer in the Publications Review Committee to ensure accurate representation of clinical trial results.
Education/Experience
Qualified candidates must have MD, PhD or PharmD with extensive cancer research and pharmaceutical experience with a minimum of 7 years of combined research and pharmaceutical/clinical trial experience with focus on cancer research/clinical studies, including minimum of 4 years Oncology experience in pharma. Expertise in clinical trial design; and understanding of pharmaceutical business, worldwide drug development and regulatory process is required in this role. Research or clinical experience in therapeutic area is highly desirable. Must be willing to travel 35% of the time.
Nearest Major Market: New York City
Nearest Secondary Market: Newark
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Source: http://www.daiichisankyo-jobs.com