Senior Medical Director, Clinical R & D 10/9/2017

Celgene Summit, NJ

Summit, NJ
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Entry Level (0 - 2 years)


strong Other Locations: /strong US- NJ- Summit East P Summary: /P P The Clinical Research Physician, Hematology/Oncology will be instrumental in supporting the growth of the organization as it continues to build the value of its current products and develop new products. The incumbent will have hands-on responsibility designing and executing clinical trials, and running programs focused on assigned therapeutic areas and will exhibit a passion for Phases 1 through 3, including biomarkers, proof-of-concept and full development. /P P Responsibilities will include, but are not limited to, the following: /P P Provide therapy area medical and scientific expertise to study teams and key stakeholders. /p P Lead the development of the clinical strategic plan for product/therapy area. Identify what is needed to drive the product/therapy area and the specific operational plan to get there. /p P Ensure that the strategic positioning is in line with company goals and anticipate and plan for problems/challenges and establish contingency plans and course corrections. /p P Anticipate trends in medicine and industry that may/will have an impact on the clinical/commercial viability of products and factors into planning. /p P Engage and inspire the project/clinical development team through communicating the strategic vision and the operational plan to achieve the vision. /p P Oversee quality, coordination and timeless of clinical sections of IND's, Investigator Brochures, CTA's , ISS', ISE's and clinical expert reports. /p P Represent the team with internal and external leaders and instill confidence in stakeholders by possessing a broad knowledge of the pharmaceutical industry and business environment and their impact on the product/therapy area. /p P Work with Therapeutic Area Head and other team members to prepare abstract, manuscripts and presentation for external meetings as well as author clinical sections of regulatory documents (IB, IND sections). /p P Lead the development of a significant clinical development budget and effectively manage resources, funding and expenses. /p P Cultivate and nurture strong collaborations, relationships and support with Investigators, Academic partners and KOL's. /p P Collaborate extensively with Business Development, Senior R&D and Commercial leadership to identify, recommend and develop strategic alliances, partnership and licensing opportunities requiring due diligence work and strategic input. /p P Serve as a global lead for one or more functions such as: Clinical Science, Clinical Quality, Disease Area, Product Champion, Region CRD Development and Business Development. /p P The ability to establish, communicate and drive a vision and strategy for the therapy area/product and develop and integrated plan of action including milestones and endpoints and ensure executional excellence. /p P Viewed as a global leader with the therapeutic area/disease state and considered a scientific contributor and innovator within internal and external spheres of influence. /p P The ability to think globally, strategically and innovatively about the future of the disease state and company's therapeutic agents and possess a solid understanding of the pharmaceutical industry, company competition and commercial side of business, including Marketing and Sales, Market Access, Pricing/Reimbursement, Business Development, Medical Affairs and Supply Chain. /p P Attract and develop talent, coach and mentor others to higher levels of performance. Create an atmosphere of innovation and continual improvement. /P