Novo Nordisk Inc.
800 Scudders Mill Road
Plainsboro, NJ 08536
Requisition ID: 36439BR
Title Director:Medical Affairs Clinical Strategy & Operations
Job Category :Medical Affairs
Job Description :
1. Lead the Clinical Operations team in the diabetes and Obesity Medical Affairs department to develop and execute clinical operations strategic plans across the diabetes and obesity portfolio to support the current and future commercial and scientific objectives of the company.
2. Partner with U.S. Competitive Intelligence, Global R&D, Medical Operations, Marketing, Medical Affairs, other cross-functional stakeholders and outside vendors to develop strategy for all clinical operations functions within Medical Affairs. Responsible for the pull though of these strategies within the Department, ensuring appropriate alignment with Global and NNI colleagues.
4. Provide long-term vision, oversight and direction of the US Investigator Sponsored Study (ISS) program. Assure scientific alignment of proposals with the Medical Product Plans and overall Portfolio strategy. Partner with Medical Affairs, Global Medical and Field Medical Affairs (FMA) to develop ISS gap analysis and efficiently review clinical/non-clinical proposals.
5. Provide medical leadership and oversight for disease state and portfolio clinical projects/processes including non-product clinical studies and initiatives. Partner with Global Medical, Medical Operations, Marketing Shaping and Clinical Development to develop and execute projects.
- Provides operational oversight for the execution of all HEOR study execution, including development of long term implementation strategies and processes to ensure HEOR projects are conducted in a timely, transparent manner, in accordance with all regulatory requirements.
- Responsible for development and execution of plans to drive collaboration between Clinical Trial Management (CTM) and Field Medical Affairs to enhance research program and investigator/patient experience. Partner with Clinical Development, Global R&D, CTM and FMA to assure appropriate clinical trial support and execution through FMA initiatives and Medical Associate Research Collaboration (MARC) field teams.
- Develops clinical operations strategic plans by evaluating a wide range of source data (Global R&D, U.S. Medical Product Plans, NNI portfolio strategy, Clinical landscape and situational assessments), providing strategic guidance to Medical Affairs research and NNI efforts.
- Assures scientific alignment of all research projects with the Medical Product Plans and overall Portfolio Strategy. Partners with Medical Strategy, Global and US Medical and Field Medical Affairs to develop gap analyses and efficiently review clinical/non-clinical proposals
Novo Nordisk is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.
Novo Nordisk will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information
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