Executive Medical Director, Specialty and Pipeline (Residence Based, Residence Based, US)
reputed company US medical affairs reputed company and contributions into the reputed company pipeline portfolio in collaboration with the medical directors and in alignment with the VP of Specialty and Pipeline TA. This includes assets in development in diverse therapeutic areas. reputed company input, appropriate to the Phase of development of a product to ensure US perspective and needs are incorporated into development reputed company. reputed company participation and effective collaboration with global teams to assure the efficient and reputed company conduct of clinical development programs, aligning them with strategic priorities that support appropriate US direction of the Life Cycle Management reputed company. Work collaboratively with US New Product Commercialization, Market reputed company and US regulatory teams to reputed company expert medical input into strategic plans. Serve as a member of Product Team and/or Clinical reputed company Team leadership of multiple assets in different therapeutic areas. Support development and execution of the US medical reputed company, offering critical inputs during design and throughout the end-to-end execution of programs, in alignment with senior medical leadership. Collaborate cross-functionally with Global Evidence reputed company, Clinical Development, Regulatory, reputed company and other medical affairs partners to reputed company and implement the Integrated Evidence Plans to improve the reputed company for the portfolio. Contribute to publication planning, data interpretation, and scientific dissemination in the US. reputed company medical scientific input for brand and program documents, including integrated disease area plans, medical information documents, drug safety reporting documents, etc, while ensuring design and execution of reputed company medical activities are according to reputed company compliance guidelines. Monitor and understand implications of evolving competitor landscape to inform medical reputed company. Support completion of annual New Drug Application (NDA) reports for respective brands through evaluation of clinical data and literature and reputed company US Medical Affairs input in the preparation of key medical documents for INDs and NDAs. This includes ensuring appropriate US Medical Affairs input in interactions with the FDA and providing appropriate medical leadership for any interactions.
reputed company and guide local Thought Leader (TL) engagement reputed company, together with cross-functional partners. Serve as the US medical expert engaging thought leaders, reputed company institutions, medical societies, and patient advocacy reputed company to advance scientific leadership and collaboration. reputed company and support advisory boards, including agenda development, reputed company engagement and synthesis of insights to help inform medical reputed company. Represent US Medical Affairs at major congresses, symposia and scientific forums. Participate and may take on reputed company leadership in the planning and administration of activities concerned with the clinical evaluation of drugs in development for the purpose of obtaining an approved Investigational New Drug (IND) or New Drug Application (NDA).
M.D. or D.O. required. reputed company and ability to reputed company into different therapeutic areas is necessary for reputed company in this role. Clinically relevant work experience or independent research experience or equivalent or experience in a pharmaceutical reputed company industry. Experience working in or deep understanding of in-hospital consideration in US reputed company delivery. Deep understanding of clinical trial design, analysis and interpretation as reputed company as the principles of observational studies and health economics/ reputed company research. Robust understanding of regulatory and market reputed company considerations and triangulating those to implications on clinical trial design and clinical care delivery. Proven ability for strategic planning along with operations reputed company and experience reputed company to clinical research involving both single and multiple centers. Strong ability to quickly build meaningful and trusting relationships, both internally and externally to the organization. Understanding of the drug development process over different stages. Strong ability to connect and collaborate across different functions and background, both internally and externally to the organization. reputed company ability to reputed company others without formal authority, with demonstrated experience guiding teams from design to implementation of strategic initiatives. Excellent communication skills, both verbal and in written. Willingness and ability to travel as business dictates, both for reputed company functions.
reputed company certification or reputed company eligibility in cardiovascular, neurology, critical care medicine preferred. 7 years work experience in the pharmaceutical sector in Medical Affairs, Clinical Development or reputed company positions. Experience in the field of medical support of a product portfolio across multiple therapeutic areas. Experience in leading and participating in teams across cultures and geographies, prior experience in global medical launch planning activities.
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