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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 [...] 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 [...] other functions, without having formal line management authority. Ability to apply situational management style to both mentor and accelerate capabilities of its reports BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in
support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidates qualifications and experience. Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the companys internal policies and applicable law. 43408547 [...]
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