Clinical Research Head, Incubator/Heart
Over The Counter - Parsippany, NJ

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The Clinical Research Category Lead is the responsible clinical delegate to the respective Category and strategically and operationally leads and directs the clinical development of products, trial activities and people in this indication area within Clinical Research and in close alignment with the Category. This role requires strong clinical experience and people management skills as well as a proven track record of successful project delivery. Oversee and lead the design of clinical development plans and clinical protocols of Category xy product portfolio and work with relevant members of the Category to support achievement of the company’s commercial and scientific goals for products under development in the Category, including representation at Global Health Authorities. Manage, coach, and develop Senior Clinical Manager(s) in the same Category from a technical and cultural perspective, delegate work to them and hold them accountable. Provide clinical strategic input into the Category team and serve as key liaison between Global Clinical Research Departments and Category as well as Affiliates. Provide conceptual leadership and scope for development of clinical study reports and the clinical sections of regulatory dossiers, submissions, etc. Provide involvement at an early stage in project planning, recommending the most appropriate medical input for project development plans, early opportunity assessments and preparation for meetings with Health Authorities and submissions. Drive adequate planning, implementation and execution of all clinical programs to meet defined budgets and timeliness in close collaboration with Clinical Operations and CRO Management. Support commercial development activities by evaluating potential licensing opportunities and advancing the global integration of science and marketing into the various strategic considerations. Create and sustain a company culture with the highest ethical scientific standards and teamwork to achieve commercial objectives.

Minimum requirements
An accomplished M.D with 8 + years of clinical research experience in relevant life sciences industry. Experience with products in indications of Category xy or other OTC products preferred Fluent in English (oral and written), French or German desirable Minimum 8 to 10 years experience in health care or pharmaceutical industry, with the major portion spent in clinical research. Past participation in the development of clinical drug research programs and clinical trial design for the pharmaceutical industry or a clinical research organization Contacts and relationships with thought leaders in academia and Health Authorities are very helpful. Demonstrated knowledge of the clinical trial process, including multi-center trial experience. Ability to identify process improvement opportunities and develop effective solutions. A track record of success in building and leading a team of talented individuals (strong leadership, coaching, and teaching skills). Demonstrated broad-based business understanding and experience. Intuitive insight regarding the nuances of clinical trials. Strong ability to work cross-functionally within R&D, especially with Clinical Operations.

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