(Senior) Medical Director*, Clinical Development, Infectious Diseases

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Summary

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 oncology pipeline contains several classes of drugs, including mRNA-based 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 Roche, Eli Lilly, Pfizer, Sanofi, and Genmab. Comirnaty (COVID-19 vaccine) is its first commercialized product.
 

Key Responsibilities

  • He/ She will lead the strategic direction of assigned programs and will be responsible to oversee and provide guidance for the design and execution of clinical trials from early to late stage development through regulatory approval, leading a matrix team. 
  • He/She will be responsible to oversee and steer the design and execution of clinical trials of his/ her assigned programs, and is responsible for the clinical development plan for new compounds, and pave a path towards regulatory approval.
  • The Senior Director Clinical Development will work closely and represent BioNTech in collaboration projects with industry partners and also contribute to interactions with academic study investigators, advisory meetings with opinion leaders, and interactions with Health Authorities. He/ she will interact closely with the VP Clinical development by making strategic proposals on our platforms incl. overall approaches & investments. 
  • Represents the team to decision/governance meetings, senior management, or advisory boards as applicable.

Knowledge, Skills & Abilities

  • M.D. and/or M.D. Ph.D with strong scientific and clinical background in Infectious diseases. Board certification in Infectious Diseases and vaccine clinical development experience preferred.
  • Minimum of 10 years of experience within Infectious diseases 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.
  • 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 modeling and biostatistics. Complemented with 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). 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.
  • Demonstrated leadership experience and several years (>4 years) matrix management experience in a global organization. Ability to lead horizontally and drive execution of workplans in collaboration with other functions, without having formal line management authority.
  • Provides subject matter expertise and has a genuine interest to mentor and develop others.
  • 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!

BioNTech - As unique as you

https://biontech.de/biontech-us

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