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BioNTech SE
Oncologist as Director (m/f/d)
• Mainz, 55131
Führungs-/ Leitungspositionen Homeoffice möglich
(Senior)
Director, Clinical Development (m/w/d) London, United Kingdom; Berlin, Germany; Mainz, Germany full time Job ID:6950The Senior Director Clinical Development will work hand-in-hand with the VP of Clinical Development to steer clinical strategies and their operationalization for the assigned programs. He/ She will lead the strategic direction of assigned programs and will be responsible to oversee and provide guidance for the
design and execution of clinical trials from early to late stage development through regulatory approval, leading a matrix team. This includes thorough data interpretation based on deep scientific and disease biology understanding, translational expertise and medical knowledge, including patient safety and data integrity. They will be responsible to oversee and steer the design and execution of clinical trials of their assigned programs, helping to create 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 [...] 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 Opinion Leaders, health authorities) . Represents the team to decision/ governance meetings, senior management, or advisory boards as applicable. Responsible for supervising/ mentoring multiple studies/ clinicians. Leads horizontally in the program team members from other functions; drives overall performance of the program team M. D. [...]
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