Senior Medical Director, Oncology Clinical Development

Open for hire at one of the following locations –  Cambridge Erie Street, Gaithersburg, Mainz K1. - Job ID: 3435 

 

Become a member of the BioNTech Family!

As a part of our team of more than 5.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards – writing medical history.
 
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, Oncology Clinical Development 

 

Your primary responsibilities are:

 

• Drive the operational planning, content, execution, and delivery for our programs and studies; manage day-to-day clinical activities for our clinical studies incl. management of protocol amendments, overseeing data review activities, and communicating with investigators/sites where appropriate.
• Assume Program Lead responsibilities when assigned as clinical lead for a program, in liaison with the responsible program manager; lead the program core team
• As Program Lead, articulate targets of TPP and CDP to other development functions (e.g., Regulatory, Pharmacovigilance, Statistics, etc.) and drive alignment on objectives and expected outcomes. Drive translation of Target Product Profile into clinical strategy
• Collaborate with other development functions (e.g., Regulatory, Pharmacovigilance, Statistics, etc.) to support clarity on clinical objectives and drive alignment on objectives and expected outcomes
• Responsible for trial medical/ safety aspects and risk-benefit assessments supported by the Clinical Trial Scientists and Pharmacovigilance. Collaborate closely with Pharmacovigilance on the development of Risk Management Plans
• Collaborate and give guidance to the Clinical Trial Scientists, and work with them on a day-to-day basis on clinical trials, driving overall progress of study implementation
• Supervise ongoing medical data review
• Ensure on the program (where appropriate) and trial 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
• Take ownership together with other 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)
• Create input 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
• Ensure that the Clinical Study Report (CSR) medical content in assigned programs and trials meets high-quality expectations on medical standards, and provides respective guidance to other members of the clinical development team
• Manage relationships with key external stakeholders (industry partners, Key Opinion Leaders, health authorities)
• Represent the team to decision/governance meetings, senior management, or advisory boards as applicable
• Contribute to a collaborative culture within and outside Clinical Development and actively manage best practice sharing and capability building within the clinical team

 

 

What you have to offer.

 

• M.D. and/or M.D, Ph.D. with a strong scientific and clinical background in Immuno-Oncology and/or Oncology.
• Board certification in Oncology/Hematology or preferred
• Several years of experience within Immuno-Oncology, Oncology or Infectious diseases at the biotech/pharmaceutical and the academic setting, including leading clinical development activities, ideally from exploratory Phase I/II clinical trials through late stage development in Phase III and NDA/BLA submission
• Good understanding of the clinical and scientific methods and approaches used in clinical development, from FIH to registration; experience with regulatory processes and registration a plus
• Ability to write high-quality and executable trial designs and protocols
• Hand-on experience in managing the ongoing clinical day-to-day work for the successful delivery of clinical trials
• Experience in liaising with clinical operations as well as with epidemiology on a regular basis for efficient clinical trial