Safety Physician* Oncology

Become a member of the BioNTech Family!

BioNTech is a Germany-based biotechnology company with U.S. offices in Cambridge, MA and Gaithersburg, MD, that focuses on developing cancer therapeutics, including individualized immunotherapy, as well as vaccines for infectious diseases, including COVID-19. The company's oncology pipeline contains several classes of drugs, including mRNA-based drugs to encode antigens, neoantigens, cytokines, and antibodies; cell therapies; bispecific antibodies; and small-molecule immunomodulators. BioNTech is partnered with several large pharmaceutical companies, including Roche, Eli Lilly, Pfizer, Sanofi, and Genmab. Comirnaty (COVID-19 vaccine) is its first commercialized product.

Clinical Safety Physician* Oncology (Pharmacovigilance)

The Clinical Safety Physician is responsible for the safety monitoring of assigned development products and performs risk management and signal management activities under the supervision of the respective Development Safety Strategy Lead and supports safety writing activities.
The Clinical Safety Physician acts as a medical safety expert for the development of BioNTech’s vaccines, oncology or other assigned development products under the guidance of the Head of Development Safety.
The Clinical Safety Physician acts on the individual clinical trial level, is a core team member of the clinical study team and supports the respective Development Safety Strategy Lead within the multidisciplinary development team.

Main responsibilities:

• Perform Clinical Safety tasks on individual clinical trial level (e.g. medical assessments of SAEs, AESIs, DLTs)
• Primary addressee for the Clinical Safety Managers, Medical Monitors and the CRO on all safety-related topics on clinical trial level, core trial team member.
• Oversee the benefit-risk profile of assigned development products in accordance with the Development Safety Strategy Lead

• Provide medical input related to safety aspects of the assigned development products and writing and approval of safety sections in the essential clinical trial documents
• Provide regular safety updates to the Development Safety Strategy Lead, the Head of Development Safety and the clinical trial core team

Key Accountabilities:

• Providing medical safety expertise on clinical trial level for assigned products under development
• Providing high quality medical input for the safety aspects of all relevant documents including SAEs, AESIs, DSURs, study reports, responses to regulatory authorities, and submission packages in a timely fashion
• Contribute safety expertise to cross-functional development teams

What you have to offer.

• Medical Degree, specialist training in oncology or hemato-oncology preferred
• At least 2-3 years of experience in clinical trial in the field of immuno- oncology/cellular therapies or in the field of clinical development or medical safety surveillance
• Experience in data analysis and reporting of results from clinical experiments
• Knowledge of the concept and measures to maintain data integrity
• experience with electronic data management systems to achieve and maintain data integrity throughout
• Expert knowledge of GCP and global clinical safety regulations
• Experience in set-up and monitoring development safety activities for clinical trials including SAE assessments, SUSAR reporting, signal management and safety writing
• Experience in analyzing safety data from clinical trials in an aggregate manner and identifying safety signals and risks
• Experience in working with CROs and safety service providers
• Proven team player and excellent communication skills
• Excellent English writing skills

Benefits for you.

• What we offer
• Medical, Dental and Vision Insurance
• Life, AD&D, STD and LTD Insurance
• HRA & FSA Spending Accounts
• Health & Wellness, including free onsite gym access
• Adoption & Surrogacy Assistance
• Vacation and Unlimited Sick Time
• Holidays and Floating Holidays, including discretionary winter shutdown
• 401(K) Plan with Significant Company Match
• Tuition Reimbursement and Professional Development
• Commuting Assistance 
• Discounted Home and Auto Insurance
• Pet Insurance

Have we kindled your pioneering spirit?

Then apply now for our location Cambridge (Boston) and simply send us your application documents using our online form. #LI-DCA

*BioNTech does not differentiate on the basis of gender, race or ethnicity, religion, color, sexual orientation or identity, disability, age and other protected statuses as given by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer. Most important – it’s a match!

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