Associate Director, Clinical Sciences

BioNTech • Berkeley Heights, NJ

47d

About The Position

As Associate Director, Clinical Science, you will work in a cross-functional clinical matrix team, fostering a collaborative environment to drive the successful design, execution, and delivery of oncology clinical trials. You will be a key collaborator for various clinical trial activities including optimizing clinical trial processes, proactively identifying risks, implementing mitigation strategies, and ensuring the highest standards of data integrity are upheld. The role requires you to ensure that all study objectives and deliverables align with regulatory, ethical, and reporting requirements, supporting robust medical governance and compliance across clinical programs. Working closely with the Medical Director, you will play an integral part in protocol development and trial execution, leveraging your expertise to shape study design and operational strategies. You will engage both internal and external scientific experts to inform clinical strategy, interpret emerging data, and incorporate best practices into trial conduct. You may also provide mentorship, guidance, and oversight to junior colleagues to help cultivate a culture of excellence and continuous improvement within the clinical science team.

Requirements

• Bachelor's degree in life sciences, healthcare, or nursing required; advanced degree preferred.
• At least 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.
• Skilled at fostering collaboration across cross-functional teams, stakeholders, and external partners to drive project success and support strategic objectives.
• 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.

Responsibilities

• Work collaboratively with the clinical science team to help inform program strategy for designated clinical trials and compounds and play a role in developing comprehensive clinical development plans.
• Design clinical trials to assess the safety and effectiveness of investigational oncology drugs, covering protocol development, patient population identification, endpoint selection, and optimal study design.
• Lead or co-author and review essential clinical and regulatory documentation as appropriate, including protocols, informed consent forms (ICF), investigator brochures (IB), annual safety updates, study reports, and regulatory submissions required for compound registration and commercialization, etc.
• Oversee clinical trial execution, ensuring adherence to protocols, regulatory standards, and ethical guidelines. Monitor study progress, review data, and manage adverse event reporting and resolution
• Work with the clinical development team to address regulatory and health authority inquiries and maintain compliance with applicable guidelines.
• May contribute to the planning and execution of the Clinical Development Plan, Integrated Evidence Plan, and clinical aspects of the Target Product Profile (TPP).
• Assist in organizing and participating in study/ program related meetings, such as Investigator Meetings, KOL meetings, Data Monitoring Committee meetings, for investigator meetings, CRO/CRA training sessions, and site initiation visits (SIVs) as needed etc.
• Collaborate with data management for the development and review of electronic case report forms (eCRFs) and associated completion guidelines, UATs, and oversee the deployment of data capture tools.
• Conduct thorough clinical data reviews, identify trends and insights, and support interim analyses, database lock activities, and the resolution of scientific and medical issues during the study lifecycle.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees