Vice President* Clinical Development
- Work experience
- Manager First Level
- Medicine, Pharmacy, Laboratory
- Research, development, teaching
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We aim to achieve life-changing successes for patients by being innovative, passionate and united,so 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.
Vice President* Clinical Development
He/she will efficiently leverage experience to advance BioNTech's global development candidates to regulatory approval and to a competitive label, in close alignment with the CMO and global teams.
He/she will actively contribute to building a cohesive high-performing Clinical Development team with the appropriate expertise corresponding to BioNTech´s dynamically growing pipeline.
The VP Clinical development will establish and drive networks with key opinion leaders (KOL) in related areas. He/ she will represent BioNTech in collaboration projects with industry partners, as well as in interactions with academic study investigators, advisory meetings, as well as with Health Authorities. He/ she will partner with the CMO to make strategic proposals on our portfolios and 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, Immuno-Oncology or Infectious Diseases are critical for success.
Your main responsibilities are:
- 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.
- Lead and gives direction for the formulation of clinical development strategies and their operationalization of a portfolio and its respective platforms. Owns the strategy and operational planning, content, execution and delivery for a portfolio and its platforms.
- Gives guidance for (Senior) Directors of his/ her team to fulfill responsibilities in the assigned programs and on expected outcomes. Has overarching accountability that Target Product Profile is translated and implemented in clinical strategy.
- Oversees that targets of TPP and CDP are cross-functionally shared, jointly owned and understood (e.g. Regulatory, Pharmacovigilance, Epidemiology, RWE, Medical Affairs) and drives ongoing alignment on objectives and expected outcomes of the portfolio and platforms.
- Responsible for study medical/ safety aspects and risk-benefit assessments supported by the study Medical expert and Pharmacovigilance. Collaborates closely with Pharmacovigilance on development of Risk Management Plans.
- Ensures on portfolio and strategic 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).
- Oversees 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.
- Owns relationships with key external stakeholders (industry partners, Key Opinion Leaders, health authorities). Represents BioNTech vis-à-vis senior external stakeholders, like member in Joint Steering Committees (JSC). Safeguards any issues are identified early and mitigation and action plan is put in place.
- Most senior contact person for a platform versus internal decision & governance meetings, senior management, or other forums.
- Direct line management and mentoring of senior clinical development resources; responsible for recruiting, onboarding and continuous capability building of its reports. Delegates activities as appropriate and communicates overarching objectives of TPP and CDP, to ensure team alignment.
- Role-models standards of highest clinical quality, driving consistent practices with the highest ethical standards in compliance with internal SOPs, local regulations and laws.
What you have to offer.
- M.D. and/or M.D. Ph.D with strong scientific and clinical background in Immuno-Oncology, Oncology or Infectious diseases. Board certification in Oncology/Hematology or Infectious Diseases preferred.
- Minimum 12 years of experience in the biotechnology/ pharmaceutical industry and academic setting in the field of Oncology/Immuno-Oncology or Infectious Diseases, including a thorough understanding of early and late drug development process from IND through NDA/BLA.
- Deep experience in leading drug development programs ( incl. for example demonstrated successes in novel clinical trial designs, application of companion diagnostics for patient selection, clinical pharmacology, clinical operations, pharmacovigilance and submission experience).
- Strong sophistication with the global regulatory environment (incl. FDA, CFDA, PMDA, EMA) and respective standards, including hands-on experience in driving the simultaneous drug development in several global regions, interacting with senior officials of Health Authorities and achieving a competitive product label.
- Strategic view on the pharmaceutical industries, its key trends and innovation and how drug development landscape is going to evolve.
- Experience in translational and clinical cancer research, and/ or Drug development experience in oncology and/ or Immuno-oncology.
- Experience with RWE, HEOR, Medical Affairs and other data generation activities and how thy contribute to patient outcomes is a plus.
- Demonstrated successes in global roles, driving integrated approaches across multiple regions (Europe, US, Asia).
- Ability to strategize and lead a goal oriented clinical development team.
- Ability to formulate strategies for our portfolios and platforms and ability to steer their operationalization within the TPP.
- Strong experience (>5 years) in recruiting and retaining talent, as well as building their capabilities and forming high performance teams.
- Experience in driving collaborations and working with external partners, including building networks with key opinion leaders (KOL) and investigators.
- Outstanding communication skills, ability to deliver effective presentations both internally and externally, and strong networking abilities and creativity.
- Effectiveness as a matrix leader, and ability influence on multiple level of the organization.
- High proficiency in English (written and spoken); German a plus.
Benefits for you.
- Company Pension Scheme
- Company Bike
- Leave Account
- Fitness Courses
- Mobile Office
- Special Vacation
Have we kindled your pioneering spirit?
If you have any further questions, our Talent Acquisition Team will be happy to answer them on + 49 (0) 6131-9084-1291 (monday-friday, from 12 noon to 4 pm).
Job-ID 3218 (please indicate for inquiries)
We look forward to your application!
*BioNTech does not differentiate on the basis of gender, race or ethnicity, religion, color, sexual orientation or identity, disability, age and other protected statuses as given by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer. Most important – it’s a match!
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