Global Clinical Development Lead*, Infectious Diseases

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Become a member of the BioNTech Family!

BioNTech is a Germany-based biotechnology company with U.S. offices in Cambridge, MA and Gaithersburg, MD, that focuses on developing cancer therapeutics, including individualized immunotherapy, as well as vaccines for infectious diseases, including COVID-19. The company's infectious disease and oncology pipeline contains several classes of drugs, including mRNA-based prophylactic vaccines, drugs to encode antigens, neoantigens, cytokines, and antibodies; cell therapies; bispecific antibodies; and small-molecule immunomodulators. BioNTech is partnered with several large pharmaceutical companies, including Pfizer, Roche, Eli Lilly, Sanofi, and Genmab. Comirnaty (COVID-19 vaccine) is its first commercialized product.

BioNTech is looking for a physician to globally lead the development for one or more of its Infectious Diseases programs across our rapidly expanding pipeline. This role will report to BioNTech’s VP, Clinical Development for Infectious Diseases. The Global Development Lead defines the global development strategy for assigned programs, translates it into the Clinical Development Plan, and oversees its execution. The role further provides clinical and scientific guidance to the cross-functional development team to ensure high-quality and innovative program design. The Global Development Lead also ensures the timely execution of project deliverables in close collaboration with internal and external partners. As the person responsible for the medical oversight of clinical trials, this role also oversees and guides physicians from Clinical Development Infectious Disease in clinical study design, protocol development, medical monitoring, analyses, and interpretation of clinical trial data. Finally, the Global Development Lead reports the data and makes recommendations to senior management for decision-making.

​​​​​​​The position is global and can be based at BioNTech’s US or German sites. The successful candidate will be curious, collaborative, and ambitious to contribute to BioNTech’s mission to utilizing the full potential of the immune system to fight infectious diseases. As a fast-growing company, the candidate will bring self-direction and comfort to work in a fast-paced and highly dynamic environment.
 
 

Responsibilities


Your main responsibilities include, but are not limited to:
  • Steer the global development team (in liaison with the responsible program manager) for assigned programs, communicating the strategy, and providing clinical and scientific guidance to cross-functional teams (e.g., Regulatory, Pharmacovigilance, Biostatistics, etc.) to meet timely execution of clinical development project deliverables
  • Own the strategy formulation and operational planning, content, execution, and delivery for assigned programs and be a key driver of the integrated development, submission, and publication plans
  • Work with the VP, Clinical Development to make strategic proposals on BioNTech’s platforms incl. overall approaches and investments, and to steer clinical strategies and their portfolio and platform operationalization
  • Own and steer the definition of the Target Product Profile for assigned programs and translate it into the Clinical Development Plan
  • Oversee and steer the design and execution of clinical trials of assigned programs in collaboration with other Clinical Development physicians and functions
  • Take 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)
  • Take responsibility for clinical trial medical/safety aspects and risk-benefit assessments supported by the study clinical expert and Medical Safety team. Collaborate closely with Medical Safety / Pharmacovigilance in development of Risk Management Plans.
  • Own final program data and reporting to decision-making bodies, senior management, and advisory boards, as applicable
  • Represent the program to industry partners, collaborators, health authorities and trial site investigators and administrators
  • Take accountability for and guide preparation of clinical sections of key documents, including Investigator's Brochures, IND submissions, CTAs, and NDAs. Respond to questions from regulatory authorities, IRBs, and ethics committees

Knowledge, Skills & Abilities

  • MD or MD-PhD with strong scientific and clinical background in infectious diseases. Board certification in infectious diseases, internal medicine, and/or pediatrics and vaccine clinical development experience are a plus
  • Minimum 5 years of experience in early- to late-stage infectious disease vaccine or therapeutic development in an industry setting. Demonstrated ability to:
    • Plan and conduct clinical trials from exploratory Phase I/II clinical studies through late-stage development in Phase III and NDA/BLA submission
    • Deliver high-quality results within defined deadlines
    • Lead cross-functional teams and workflows (Pharmacovigilance, Biostatistics, Clinical Operations, and Regulatory Affairs)
  • Demonstrated experience as a Development Lead for a program is a plus
  • Thorough understanding of the clinical and scientific methods and approaches used in clinical development studies, including novel clinical study designs, application of companion diagnostics for patient selection, clinical pharmacology/translational modeling, and biostatistics
  • Comprehensive understanding of FDA, EMA, ICH and GCP guidelines. Prior interaction with FDA and EMA regulatory agencies is desirable
  • Demonstrated leadership experience and several years (7+ years) of line management experience in a global matrix organization
  • Ability to lead horizontally and drive execution of workplans in collaboration with other functions, without having formal line management authority
  • Strong interpersonal skills in addition to exceptional written and oral communication skills commensurate with the need to work closely with CROs, investigators, consultants, and team members across functions
  • Proficiency in English (written and spoken)

What we offer

  • Medical, Dental and Vision Insurance
  • Life, AD&D, STD and LTD Insurance
  • HRA & 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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