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BioNTech SE
Oncologist as Director (m/f/d)
• Mainz, 55131
Führungs-/ Leitungspositionen Homeoffice möglich
[...] the clinical development plan for new compounds, and pave a path towards regulatory approval. Works hand-in-hand with the VP of Clinical Development to steer clinical strategies and their operationalization of portfolios and platforms. Owns the 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 TPP and CDP to other development functions (e. g. Regulatory, Pharmacovigilance, Statistics, etc. ) and drives alignment on objectives and expected outcomes Responsible for study medical/ safety aspects and risk-benefit assessments supported by the study clinical expert and Pharmacovigilance. Collaborates closely with Pharmacovigilance on development of Risk Management Plans. Supervises ongoing medical data review and ensures medical queries of running studies are resolved Ensures at the program level, that the clinical development team works hand-in-hand with Clinical
Operations team for patient centric drug development, ensuring balancing of high medical quality, trial 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 from 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 [...]
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