(Senior) Medical Director, Clinical Development (iVAC)

Open for hire at one of the following locations –  Cambridge Erie Street, Gaithersburg, London, Mainz Goldgrube. - Job ID: 6524 

 

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We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.

 

(Senior) Medical Director, Clinical Development (iVAC) 

 

•           The 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.

•           The Senior Director 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 Clinical development by making strategic proposals on our platforms incl.  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 develop new treatments to address unmet needs in Oncology and/or Immuno-Oncology are critical for success.

 

Core 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 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 Investigator's 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 (i