Senior Manager, Clinical Development

Responsibilities

• Participate in the design and execution of clinical trials and help create clinical development plans for new compounds.
• Drive clinical strategies and operationalize them within assigned programs and trials.
• Manage day-to-day clinical activities, including protocol amendments, data review, and medical monitoring.
• Act as Trial Lead for assigned programs, collaborating with the program core team and other development functions.
• Translate Target Product Profiles (TPP) into actionable clinical strategies.
• Collaborate with Pharmacovigilance on the development of Risk Management Plans.
• Provide guidance to Clinical Trial Scientists to drive study implementation progress.
• Create medical content for key documents such as Investigator's Brochures, IND summaries, and Clinical Study Reports (CSR).
• Establish and manage relationships with external stakeholders, including industry partners, Key Opinion Leaders, and health authorities.

Requirements

• Master's degree with a strong scientific and clinical background in Immuno-Oncology or Oncology.
• Minimum of 3 years of experience in Immuno-Oncology or Oncology within biotech, pharma, or academic settings.
• Proven experience leading clinical development programs from Phase I/II through Phase III and regulatory submissions.
• Strong medical monitoring expertise, including overseeing and interpreting safety and efficacy data.
• Experience with global health authority interactions (e.g., FDA, EMA, CDE).
• Ability to write high-quality, executable trial designs and protocols.
• High proficiency in English (written and spoken).
• Demonstrated success working in a global, cross-functional matrix environment.

About the Company

BioNTech is a biotechnology company dedicated to revolutionizing medicine by translating cutting-edge science into survival. We focus on addressing high medical needs, such as cancer and infectious diseases, through innovation and a commitment to improving global health.