Senior Manager, Clinical Science

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Cambridge, US | full time | Job

As Senior Manager, Clinical Science, you will support oncology clinical trials that contribute to advancing BioNTech’s mission of developing innovative treatments. Your expertise will contribute to shaping study designs and operational strategies, ensuring data integrity and compliance. Working collaboratively with cross‑functional teams in a dynamic environment, you will support impactful clinical trial processes while promoting excellence within the clinical science team.

In this role, you will play a key role in protocol development, trial execution, and engaging with scientific experts to inform clinical strategies. Your contributions will help advance BioNTech’s goals and reinforce strong medical governance across our programs.

• Contribute to the development and creation of clinical trial protocols following high scientific and clinical standards and applicable regulations.
• Contribute to identifying, formulating, and implementing amendments to clinical protocols in close collaboration with the clinical lead.
• Create study‑level documents, including preparing clinical sections of key regulatory documents such as Investigator Brochures, briefing books, safety updates, and submission dossiers.
• Review and write clinical trial documents for CTR activities and publications (if applicable).
• Support pharmacovigilance activities (e.g., contributing to aggregate reports, patient narratives, attendance of pharmacovigilance monitoring meetings).
• Support regulatory activities, like preparation of meetings with regulatory agencies.
• Produce training materials, share best practices, and provide training to the broader clinical trial teams.
• Participate in study‑level meetings, such as Investigator Meetings, Data Monitoring meetings, etc.
• Guide the development of data review strategy, ensuring that protocol‑level deviations, eligibility criteria, study assessments, and other aspects of the protocol are implemented consistently across the study.
• Perform high‑quality clinical data review and identify clinical data insights through ongoing patient‑level review and trends analysis.
• Work to improve the quality of reviews/insights, emphasizing subject safety and eligibility, data integrity, trend identification, analysis and remediation, and identification of cases for medical review.
• Provide insights to and facilitate data review process improvements, for example, by identifying redundant reports, implementing innovative data analysis processes and tools, and their continuous improvement.
• Work in close collaboration and alignment with the clinical development lead. Ensure all questions/issues requiring medical oversight are brought to the attention of the clinical development lead.

• College degree in life sciences/healthcare/nursing with 5+ years of clinical experience is required;
  Master’s, Pharm
  
  D, MPharm, PhD, MBBS, BDS, MD strongly preferred
• Strong familiarization with Good Clinical Practice (GCP) and drug development processes, ideally Phase 1 – 3; ideally paired with experience in Oncology/Immuno‑Oncology
• Good knowledge of set‑up, organization, and execution of global clinical studies in a pharmaceutical company, contract research organizations (CROs), or comparable experience within an academic research institution
• Sound knowledge of principles of clinical data collection and reporting; demonstrated ability to use systems and tools (e.g., EDC systems, Excel, etc.) for data collection, analysis, and reporting
• High flexibility and adaptive working style, ability to work on several tasks simultaneously.
• Ability to work effectively under high time pressure while maintaining high‑quality standards.
• Ability to effectively prioritize tasks and implement accordingly.

Expected Pay Range: $130,800 - $183,500/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance).
* Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities.

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