Cambridge, US; London, United Kingdom | full time | Job ID: 8976

Responsibilities:

Contribute to designing clinical trials to evaluate the safety and efficacy of investigational drugs. This includes developing the study protocol, identifying patient populations, selecting study endpoints, and determining the appropriate study design Responsible for clinical development oversight of clinical trials to ensure that they are conducted in accordance with the protocol, regulatory requirements, and ethical standards. This includes monitoring study progress, reviewing study data, and ensuring that adverse events are reported and managed appropriately. Contribute to and/or lead the creation of study-level documents, including protocol development, preparation of clinical sections of key regulatory documents, such as Investigator’s Brochures, briefing books, safety updates and submission dossiers. Contribute to the review and writing of clinical trial documents for CTR activities, and publications (if applicable). Under guidance of Clinical Development Lead, address regulatory/health authority queries and ensure compliance with guidelines. Contribute to the development of the Clinical Development Plan, Integrated Evidence Plan and the clinical component of the TPP. Collaborate with cross-functional teams, including, but not limited to, clinical operations, biostatistics, regulatory affairs, and medical affairs, to ensure the successful execution of clinical development programs. Develop protocol and clinically relevant training materials, share best practices and provide training to the broader clinical trial teams, investigator sites, CRO partners, etc. Collaborate with medical safety and pharmacovigilance on safety evaluations and signal detection. Contribute to aggregate reports, patient narrative reviews, attendance of pharmacovigilance monitoring meetings) Support regulatory activities, like preparation of meetings with regulatory agencies. Support preparation and (if applicable) participate in study level meetings, for example Investigator Meetings, Data Monitoring meetings, and others. Supports and guides the development of data review strategy, ensuring that protocol-level deviations, eligibility criteria, study assessments & other aspects of the protocol are implemented consistently across the study (across countries/ sites). This could also include support for Case Report Form (CRF) development, and implementation of data capture tools. Perform high quality clinical data review and identify clinical data insights through ongoing patient level review and trends analysis, thereby supporting for example Interim Analysis, Database and Post Lock activities and resolution of scientific & medical issues throughout the study lifecycle. Work to improve the quality of reviews/ insights with an emphasis on subject safety and eligibility, data integrity, trend identification, analysis and remediation, and identification of cases for medical review. Provide insights and facilitate data review process improvements, for example by identification of redundant reports, implementation of innovative data analysis processes and tools, and their continuous improvement. Work effectively in a matrixed team within the clinical science organization. For Director level this includes providing guidance and mentorship to junior team members.

Qualifications:

College degree in life sciences/healthcare/nursing. Advanced degree preferred 8+ years of industry experience 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 or contract research organization (CRO), or comparable experience within academic research institutions. 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. Ideally first experiences in how to improve and accelerate processes, systems and tools and drive continuous improvement. Experience to work in a matrix, ability to influence without authority High flexibility and adaptive working style, ability to work on several tasks at the same time Ability to work effectively under high time pressure, while maintaining high quality standards Ability to effectively prioritize tasks, and implement accordingly High proficiency in English (written and spoken)

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
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; London, United Kingdom 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.

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