Associate Director, Clinical Sciences

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

 

 

Key Responsibilities:

• Help shape program strategy for clinical trials and compounds, contributing to Clinical Development Plans, Integrated Evidence Plans, and Target Product Profiles (TPP)
• Design and oversee clinical trials, including protocol development, patient population identification, endpoint selection, and study design.
• Monitor study progress, review data, manage adverse events, and address scientific and medical issues throughout the study lifecycle.
• Co-author and review clinical and regulatory documents (e.g., protocols, informed consent forms, investigator brochures, study reports, regulatory submissions).
• Support regulatory processes, including preparing for and participating in meetings with regulatory agencies.
• Collaborate with cross-functional teams (e.g., clinical operations, biostatistics, regulatory affairs, medical safety, and pharmacovigilance) to ensure successful program implementation and safetyevaluations.
• Develop training materials and provide training for clinical trial teams, investigator sites, and CRO partners.
• Prepare and deliver presentations for investigator meetings, training sessions, and site initiation visits (SIVs).
• Conduct clinical data reviews, identify trends, and support interim analyses and database lock activities.
• Implement strategies to improve data review quality, focusing on patient safety, data integrity, and innovative analytics tools.
• Guide study plans, manage protocol adherence, and oversee deviations, eligibility criteria, and assessments.
• Develop and review electronic case report forms (eCRFs) and oversee deployment of data capture tools.
• Collaborate within a matrixed clinical science team and provide mentorship to junior colleagues.

 

Qualifications:

• Bachelor's degree in life sciences, healthcare, or nursing required; advanced degree preferred with a minimum of 8 years of clinical development experience, preferably in oncology or immuno-oncology.
• Comprehensive understanding of Good Clinical Practice (GCP) and all phases of drug development (Phase 1–3).
• Demonstrated expertise in planning, organizing, and executing global clinical studies within a pharmaceutical company, CRO, or academic setting.
• Strong foundation in clinical data collection and reporting, with proficiency in systems and tools(e.g., EDC platforms, Excel) for data analysis and reporting. Experience in process and tool optimization is highly desirable.
• Proven ability to work effectively in a matrix environment and influence stakeholders without direct authority.
• Ability to manage high workloads and tight deadlines while maintaining quality standards.
• Excellent task prioritization and implementation skills.

 

 

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