(Senior-) Director Clinical Development (Infectious Disease)

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(Senior-) Director Clinical Development (Infectious Disease) 

 

The Senior Director of Clinical Development will work with the VP of Clinical Development to steer clinical strategies and operationalize them for the assigned programs. They will lead the strategic direction of assigned programs. They will 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, medical knowledge, patient safety and data integrity. The Senior Director of Clinical Development will be responsible for overseeing and steering the design and execution of clinical trials for his/ her assigned programs, helping to create the clinical development plan for new compounds, and paving a path toward regulatory approval. The Senior Director of Clinical Development will work closely and represent BioNTech in collaboration projects with industry partners and also contribute to interactions with academic study investigators, advisory meetings with opinion leaders, and interactions with Health Authorities. He/ she will interact closely with the VP of Clinical development by making strategic proposals on our platforms, including overall approaches & investments. A genuine interest and understanding of the science supporting the pipeline, an ability to lead and work collaboratively in a multidisciplinary team setting, and a commitment to developing new treatments to address unmet needs in Infectious Diseases are critical for success.

 

Responsibilities:

•           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 integrated 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 the 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 the Clinical Operations team for patient-centric drug development, ensuring the 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 Investigator's Brochures, IND summary documents, CTAs, responses to questions from regulatory authorities, IRBs and ethics committees, and NDAs.