Vice President*, Clinical Development

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Summary

The Vice President (VP) Clinical Development in conjunction with the CMO will lead the strategic direction and be a key driver in drug development for both time and quality, with responsibility for development activities for one of our portfolios in Immuno-Oncology or Infectious Diseases. With his/ her team oversee the strategy formulation for the portfolio and platform and steer the operationalization in clinical trials towards regulatory approval.
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.

Key Responsibilities

  • 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 portfolio 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.
  • 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 and standards, 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 are 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 (Senior Directors/ Directors/ Associate Directors). 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.

Knowledge, Skills & Abilities

  • 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 [EL1] 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 to 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

What we offer

  • Medical, Dental and Vision Insurance
  • Life, AD&D, STD and LTD Insurance
  • HSA & FSA Spending Accounts
  • Health & Wellness, including free onsite gym access
  • Adoption & Surrogacy Assistance
  • Vacation and Unlimited Sick Time
  • Holidays and Floating Holidays, including discretionary winter shutdown
  • 401(K) Plan with Significant Company Match
  • Tuition Reimbursement and Professional Development
  • Commuting Assistance and free onsite parking
  • Discounted Home and Auto Insurance
  • Pet Insurance
  • And more!

To Apply, EEO and BioNTech Websites

Then apply now for our location Cambridge (Boston) and simply send us your application documents using our online form. #LI-DCA

*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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