Associate Director, Safety Scientist

Cambridge, US; Florida, US; Gaithersburg, US; Mid-Atlantic North, US; Mid-Atlantic South, US; NY Metro, US; New England, US; New Jersey, US; Southeast, US | full time | Job ID: 11009About this Role:The Associate Director, Safety Sciences provides scientific expertise for medical safety tasks. Core responsibilities include safety data review and analysis from different sources, periodic report authoring and the oversight of the safety surveillance activities for the assigned program(s). The Safety Scientist ensures that all processes are conducted according to BioNTech´s written procedures, laws and regulations. The Associate Director Safety Sciences participates in audits and inspections as Subject Matter Expert and works in close collaboration with the Safety Physician to author relevant safety sections of clinical trial documents for the assigned program(s).Your Contribution:Perform cumulative safety data reviews across trials or programs to assess safety profiles and identify emerging risks or trendsOversee the Safety Surveillance activities, including signal detection, literature reviews, and aggregate safety data analysis using tools like Safety Dashboards, Spotfire, and ElluminateCollaborate with Safety Physicians to review and align on safety data conclusions for informed decision-making regarding assigned program(s)Author periodic reports such as DSURs, PSURs, PBRERs, Risk Management Plans (RMPs), and provide input into structured Benefit Risk Assessments (sBRAs)Provide input into regulatory submissions (e.g., BLA, Module 2.7.4/2.5) and respond to Health Authority queries with scientifically sound responsesContribute or be the primary safety contact person to/for to clinical trial-related documents including Investigator’s Brochures (IBs), Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Statistical Analysis Plans (SAPs), and eCRF setupMentor new team members by providing training on core safety processes and fostering their development within the organizationAct as Subject Matter Expert during audits and inspections for key safety processes such as Safety Surveillance and aggregate report generationA Good Match:Advanced degree in life sciences/healthcare; PhD in a relevant discipline or post-doctoral pharmacovigilance certification preferredAt least 5 years of experience in clinical research with significant exposure to pharmacovigilance activities within biotech/pharmaceutical industries or CROsExpert knowledge of pharmacovigilance laws/regulations as well as GCP/GVP guidelinesProven experience in designing and implementing clinical safety processes/tools and assessing/reporting safety data from clinical trialsStrong communication skills for organizational/scientific matters with an ability to influence through persuasive appearanceProactive mindset with a solution-oriented attitude; adept at handling ambiguity with a balanced approachHigh ethical standards serving as a role model within the organizationFluency in written and spoken English Expected Pay Range is $146,300/year to $234,100/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 InsuranceLife, AD&D, Critical Illness InsurancePre-tax HSA & FSA, DCRA Spending AccountsEmployee Assistance & Concierge Program (EAP) available 24/7Parental and Childbirth Leave & Family Planning AssistanceSitterstream: Virtual Tutoring & Childcare MembershipPaid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown.401(K) Plan with Company MatchTuition Reimbursement & Student Loan Assistance ProgramsWellbeing Incentive Platforms & IncentivesProfessional Development ProgramsCommuting Allowance and subsidized parkingDiscounted 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; Florida, US; Gaithersburg, US; Mid-Atlantic North, US; Mid-Atlantic South, US; NY Metro, US; New England, US; New Jersey, US; Southeast, 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.