Medical Director* UK (Vice President / Senior Director)

Open for hire at one of the following locations – London. - Job ID: 5835
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.
Medical Director* UK (Vice President / Senior Director)
We are looking for you to join us as Medical Director in the UK to spearhead the implementation of new cancer vaccine trials in the United Kingdom and to help drive our clinical development initiatives for our Individualized Cancer Vaccines in the UK and beyond. This role is on a Senior Director or Vice President level and reports into our Chief Medical Officer, working closely with her and her leadership team at the heart of the BioNTech story. You will be leading our mission to deliver individualized 10.000 cancer vaccines by 2030 in partnership with the UK Government and help giving patience access to this groundbreaking therapeutic platform at scale.
Apart from the experience and skills described below, this role requires an absolute team player that brings an extraordinary degree of flexibility and accountability to thrive in our fast-paced Pioneer culture. 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 (Immuno-)Oncology are critical for success.
Responsibilities:

• Oversee the successful implementation of new cancer vaccine trials in a partnership with the UK’s National Health Service according to the guidelines outlined in the major agreement with the UK government.
• Develop a ‘patient-centric trial’ concept and oversee its implementation at program level, ensuring balancing of high medical quality, trail complexity, as well as time and cost considerations.
• Provide strategic leadership to advance BioNTech´s global development candidates to regulatory approval and to a competitive label, in close alignment with the CMO and global teams, considering scientific advancements, market trends, and patient needs.
• Lead and give direction for the formulation of clinical development strategies and their operationalization of assigned platforms and programs while ensuring compliance with regulatory and ethical standards.
• Overarching accountability that Target Product Profile is translated and implemented in clinical strategy. Oversee that targets of TPP and CDP are cross-functionally shared, jointly owned and understood (e.g., Regulatory, Biostatistics) and drive ongoing alignment on objectives and expected outcomes.
• Responsible for study medical/ safety aspects and risk-benefit assessments supported by the study Medical Expert and Pharmacovigilance. Collaborate closely with Pharmacovigilance on development of Risk Management Plans.
• Collaborate with Medical Affairs to align on data gaps, data generation activities, strategic congress management, external partner management and launch readiness plans.
• Work closely with contract research organizations (CROs), clinical sites, and external vendors to oversee the selection, qualification, and management of trial partners. Ensure that the team works hand-in-hand with Clinical Operations team.
• Own and ensure 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.
• Establish and/or foster relationships with key opinion leaders, industry partners, and other stakeholders to enhance the scientific credibility and impact of the trials.
• Communicate progress and findings to relevant stakeholders representing the team at decision/governance meetings, senior management, or advisory boards as applicable.
• Lead innovation in program and trial design and mentor clinical teams.
  

What You Have To Offer

• M.D. and/or M.D. Ph.D. with strong scientific and clinical background in Immuno-Oncology, Oncology. Board certification in Oncology/Hematology.
• Minimum of 10 years of experience in managing clinical development activities within Immuno-Oncology, Oncology at the biotech/pharmaceutical and the academic setting, including leading clinical development programs from exploratory Phase I/II clinical studies through late-stage development in Phase III and NDA/BLA submission.
• Familiarity with UK regulatory requirements for clinical trials and drug development.
• Thorough understanding of the clinical and scientific methods and approaches used in clinical development studies, as novel clinical study designs, application of companion diagnostics for patient selection, clinical pharmacology/ translational modelling and biostatistics. Several years of experience on confirmatory PH3 trial design and respective dossier preparation and submission activities.
• Experienced in global health authority interactions (EMA, FDA, CDE, MHRA). Having participated or led a drug development program to successful registration is an advantage.
• Strong medical experience in overseeing and interpreting safety and efficacy clinical trial data and ensuring appropriate contact for study medical and patient safety aspects.
• Strong leadership and communication skills.
• Demonstrated leadership and matrix management experience in a global organization. Ability to lead horizontally and drive execution of workplans in collaboration with other functions, prioritize tasks, and meet strict deadlines.
• Experience with driving state of the art collaborations with external academic and industry partners.
• A genuine interest and understanding of the science supporting the clinical development programs. Confident to discuss and present scientific and mechanistic aspects of drug development.
• Demonstrated track record of successful project management in a scientific or clinical setting.
• Proficiency in English (written and spoken)
  

Benefits for you
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 candidate’s qualifications and experience.
Click here to find out more about what we do, the careers we offer and also the benefits we provide.
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 company's internal policies and applicable law.
Have we kindled your pioneering spirit?
This vacancy is to be hired at one of the following locations – London . Apply now for your preferred job and location through our careers site .

• BioNTech does not tolerate discrimination, favoritism, or harassment based on gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!