BioNTech SE · 12 hours ago
Senior Manager, Clinical Science
Cambridge, MA
Contract
Onsite
Senior Level
$131K/yr - $184K/yr
5+ years expBioNTech SE is focused on advancing innovative treatments in oncology, and they are seeking a Senior Manager, Clinical Science to support clinical trials. This role involves shaping study designs, ensuring data integrity, and collaborating with cross-functional teams to promote excellence within the clinical science team.
Health Care
Responsibilities
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
Qualification
Required
College degree in life sciences/healthcare/nursing with 5+ years of clinical experience is required
Strong familiarization with Good Clinical Practice (GCP) and drug development processes, ideally Phase 1 – 3
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
Preferred
Master's, PharmD, MPharm, PhD, MBBS, BDS, MD strongly preferred
Experience in Oncology/Immuno-Oncology
Benefits
Medical, Dental and Vision Insurance
Life, AD&D, Critical Illness Insurance
Pre-tax HSA & FSA, DCRA Spending Accounts
Employee Assistance & Concierge Program (EAP) available 24/7
Parental and Childbirth Leave & Family Planning Assistance
Sitterstream: Virtual Tutoring & Childcare Membership
Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown.
401(K) Plan with Company Match
Tuition Reimbursement & Student Loan Assistance Programs
Wellbeing Incentive Platforms & Incentives
Professional Development Programs
Commuting Allowance and subsidized parking
Discounted Home, Auto & Pet Insurance
Company
BioNTech SE
At BioNTech we understand that every cancer patient’s tumor is unique and therefore each patient’s treatment should be individualized.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
James Ryan
Chief Legal Officer and Chief Business Officer
Recent News
2025-10-21
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