Senior Manager, Clinical Science

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.

Qualifications:

• College degree in life sciences/healthcare/nursing with 5+ years of clinical experience is required; Master’s, PharmD, 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.

Your Benefits:

BioNTech US is committed to employee wellbeing and offers best-in-class benefits & HR programs to support an inclusive & diverse workforce. Salaried/Position-Targeted Hourly Employees working 30+ hours per week are eligible for our comprehensive benefits package. Benefits include but are not limited to:

• 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

…and more! More details to be shared.

Home to dozens of research institutions, biopharmaceutical companies, life science incubators, venture capital firms, and over 30 million square feet of laboratory space, Cambridge, Massachusetts has earned a reputation as the #1 life science cluster in the world. As part of the Greater Boston area, the city is often referred to as the "biotech supercluster" due to its high concentration of life sciences firms. This unique ecosystem is the result of a model partnership between academia and industry, fostering collaboration and innovation and driving the development of new therapies, medical devices, and diagnostics. As Cambridge’s thriving life sciences industry continues to evolve, the city remains a beacon of knowledge, innovation, and collaboration, poised to shape the future of science and technology.

Apply now - We look forward to your application!

Apply for our Cambridge, US location and simply send us your documents using our online form.

By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.