Director MSPv, Safety Physician

Company: BioNTech SE

Job Overview

Location: Cambridge, US; Gaithersburg, US; New Jersey, US | Employment Type: Full Time | Job ID: 9397

The Medical Safety Physician is assigned to one or more study management team(s) in the oncology therapeutic area and together with the assigned Safety Scientist(s) provides Medical Safety Support to the team. Direct responsibilities of the Safety Physician include input to clinical trial protocol, study site (investigator) training, safety data assessments including adverse events of special interest, assessment of individual serious adverse events, determining the follow up information needed, safety signal detection and evaluation activities, and oversight of compliance with GCP and reporting regulations. The Safety Physician contributes to the periodic safety reports (DSUR), the relevant updates of reference safety information, the Investigator´s Brochure, and Clinical Trial Report.

This is an exciting time to assume a strategic role in MSPv and help translate science into survival by shaping the culture of patient safety for the wider BioNTech organization.

Main Responsibilities

• Accountable for the quality performance of one or more safety management team(s) (SMTs).
• Oversees safety monitoring, signal management, and the benefit-risk of assigned products through the product life cycle.
• Identifies and leads escalation, management, and communication of safety inquiries and concerns for assigned products.
• Formulates and drives the optimal safety strategy for assigned oncology programs in clinical development at the portfolio level.
• Presents and interacts with Regulatory Authorities on safety matters.
• Oversees quality content of the safety contributions to clinical and regulatory documents such as briefing book for regulatory authority meetings, investigator’s brochure, clinical study report safety conclusion section, responses to regulatory authority inquiries, and other clinical/regulatory documents as needed.
• Participates in due diligence for BioNTech’s Licensing/Acquisition initiatives.
• Represents MSPv in Alliance management projects such as safety data exchange agreement negotiations; or joint oversight committees with development partners, and/or other collaborative development projects.
• Serves as safety subject matter expert at the portfolio level and is the arbiter for safety-related issues in any of its constituting programs.
• Ensures activities are performed in compliance with applicable law, global and local regulations, and in accordance with internal and external quality standards.
• Trains and mentors Safety Physicians and Safety Scientists.

What You Have to Offer

• Medical Degree (or internationally recognized equivalent). A MD/PhD and/or certified training in a relevant medical discipline is a plus.
• Exposure to, or direct experience in working with Regulatory Agencies on development strategies for innovative oncology products, particularly those of the US.
• Has achieved demonstrable results in a matrix organization and in a multidisciplinary team, experience in implementing GCP standards in clinical trials, particularly safety reporting in compliance with global and local regulations.

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; Gaithersburg, US; New Jersey, 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.