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BioNTech SE
Oncologist as Director (m/f/d)
• Mainz, 55131
Führungs-/ Leitungspositionen Homeoffice möglich
[...] strategy formulation and operational planning, content, execution and delivery for assigned programs and will be a key driver of the integrate development, submission, and publication plan. Assumes Program Lead responsibilities in the assigned programs, in liaison with the responsible program
manager. Leads the program core team. Creates and translates Target Product Profile into clinical strategy. As Program Lead, articulates targets of [...] complexity, as well as time and cost considerations Takes ownership together with partner functions in Development on the acceleration of program and trial design and innovation for the patient (e. g. digital endpoints, synthetic control arms, RWE/ HEOR, PRO, Medical
Affairs) Owns and ensures preparation for clinical sections of key documents, including Investigators Brochures, IND summary documents, CTAs, responses to questions [...] regulatory authorities, IRBs and ethics committees, and NDAs. Oversees Clinical Study Report (CSR) medical content meets high quality expectations on medical standards, provides respective guidance to other members of the clinical development team Establishes, leads, and manages relationships with key
external stakeholders (industry partners, Key Opinion Leaders, health authorities) . Represents the team to decision/ governance meetings, senior management, or advisory [...]
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