Clinical Safety Scientist, Infectious Diseases and Vaccines

  • Cambridge, Massachusetts
  • Work experience
  • Research, development, teaching
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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 Scientist, Infectious Diseases and Vaccines

  • Support the Safety Strategy Lead in detecting and evaluating signals and establishing the Benefit-Risk profile of Vaccine products in the product portfolio.
  • Support the safety physician and PV manager in a timely and competent manner in the analysis of safety data from the clinical trials for various clinical programs.
  • Support the safety physician and PV manager in the medical assessment of individual case safety reports that qualify, or potentially may qualify for expedited regulatory reporting other serious and non-serious reports, in the context of medical safety surveillance
  • Perform Clinical Safety tasks on individual patient level (e.g. medical assessments of Serious Adverse Events and Adverse Events of Special Interest.) as directed by the Safety Strategy Lead or the Safety Physician
  • Conduct the analysis of an individual event, case, or aggregate data for signal detection, and Signal Evaluation.
  • Conduct and document all steps in the Signal Management process.
  • Monitor the benefit-risk profile of assigned development products 
  • Provide medical safety input to the writing and approval of safety sections in key regulatory and clinical documents
  • Provide regular safety updates to the clinical trial core team
  • Prepare analysis of clinical data, as well as available post-marketing data for DSURs, PBRERs, IND Annual Reports, safety review meetings, or reports for internal or external stakeholders
  • Prepare or support in the preparation of creation of core risk management plans, EU RMPs, Development RMPs, or Risk Outlines for the products.
  • Manage and support the conduct of PV safety meetings, DSMB, IRC, or SMT meetings
  • Set up procedural standards for the conduct of PV activities in signal management.
  • Maintain a program plan of all activities and deliverables related to drug safety
  • Conduct signal detection based on available sources of data including literature and post-marketing data
  • Represent MSPV in product team meetings and all activities related to MSPV where safety presentation is critical for the success of the company and its products
  • Educate the organization on topics of disproportionality ratios, observed vs expected ratios , or other relevant concepts in the preparation of Signal Evaluation Reports

What you have to offer.

  • Medical Degree; a doctor (MD) or a nurse (BSN) by education. A Ph.D. and/or specialist training in internal medicine, infectiology, public health, or other relevant discipline is a plus.
  • Experience as a clinical or PV scientist for clinical trials, preferably with experience in the area of vaccines and/or anti-infective therapies   
  • Experiences in vaccine clinical development in the biotech or pharmaceutical industry or equivalent
  • Practical knowledge of vaccine trials in the population and/or clinical trials in low-grade infrastructure geographies 
  • Experience in data analysis and reporting of results from interventional clinical trials 
  • Excellent English writing skills

Benefits for you.

  • Medical, Dent,al 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 and free onsite parking
  • Discounted Home and Auto Insurance
  • Pet Insurance
  • And more!

Have we kindled your pioneering spirit?

Then apply now for our location Mainz and simply send us your application documents using our online form.

We look forward to your application! 

*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!

BioNTech - As unique as you

https://biontech.de