Director / Associate Director / Senior Manager, Clinical Science

BioNTech • Berkeley Heights, NJ

10d

About The Position

BioNTech is hiring at Director, Associate Director, or Senior Manager level to contribute to clinical development programs and clinical trials evaluating the safety and efficacy of investigational drugs. The role encompasses trial design, clinical development oversight, study-level documentation, regulatory support, and collaboration with cross-functional teams. It also involves developing training materials, supporting safety evaluations, and participating in study and pharmacovigilance meetings.

The position supports clinical data review throughout the study lifecycle, including identification of clinical insights, trends, safety concerns, eligibility issues, and data-integrity concerns. The role also contributes to data-review strategy and continuous improvement of review processes, systems, and tools. At Director level, responsibilities include providing guidance and mentorship to junior team members.

Requirements

• College degree in life sciences, healthcare, or nursing.
• At least 8 years of industry experience.
• Strong familiarity with Good Clinical Practice (GCP) and drug-development processes, ideally across Phase 1–3.
• Good knowledge of setting up, organizing, and executing global clinical studies in a pharmaceutical company or CRO, or comparable experience in academic research institutions.
• Sound knowledge of clinical data-collection and reporting principles.
• Demonstrated ability to use systems and tools such as EDC systems and Excel for data collection, analysis, and reporting.
• Experience working in a matrix and ability to influence without authority.
• Flexible and adaptive working style, with ability to handle several tasks at the same time.
• Ability to work effectively under high time pressure while maintaining high quality standards.
• Ability to prioritize tasks effectively and implement accordingly.
• High proficiency in written and spoken English.

Nice To Haves

• Advanced degree.
• Experience in oncology or immuno-oncology.
• Experience in Phase 1–3 drug development.
• Initial experience improving and accelerating processes, systems, and tools and driving continuous improvement.

Responsibilities

• Contribute to the design of clinical trials, including protocol development, patient-population identification, endpoint selection, and study-design decisions.
• Oversee clinical development aspects of trials to help ensure they follow protocols, regulatory requirements, and ethical standards; monitor progress, review data, and ensure adverse events are appropriately reported and managed.
• Contribute to or lead study-level documentation, including protocols and clinical sections of Investigator’s Brochures, briefing books, safety updates, and submission dossiers.
• Contribute to review and writing of clinical trial documents for CTR activities and publications, where applicable.
• Address regulatory and health-authority queries under the guidance of the Clinical Development Lead and ensure compliance with guidelines.
• Contribute to the Clinical Development Plan, Integrated Evidence Plan, and clinical component of the TPP.
• Collaborate with clinical operations, biostatistics, regulatory affairs, medical affairs, and other cross-functional teams to execute clinical development programs successfully.
• Develop protocols and clinically relevant training materials; share best practices and train clinical trial teams, investigator sites, and CRO partners.
• Collaborate with medical safety and pharmacovigilance on safety evaluations and signal detection.
• Contribute to aggregate reports and patient-narrative reviews, and attend pharmacovigilance monitoring meetings.
• Support regulatory activities, including preparation for meetings with regulatory agencies.
• Support and, where applicable, participate in study-level meetings such as Investigator Meetings and Data Monitoring meetings.
• Support and guide development of data-review strategy to ensure consistent implementation of protocol deviations, eligibility criteria, study assessments, and other protocol elements across countries and sites.
• Support Case Report Form development and implementation of data-capture tools, as applicable.
• Conduct high-quality clinical data review and identify insights through ongoing patient-level review and trend analysis, supporting interim analysis, database and post-lock activities, and resolution of scientific and medical issues throughout the study lifecycle.
• Improve review quality and insights, emphasizing 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, including identifying redundant reports and implementing and continuously improving data-analysis processes and tools.
• Work effectively in a matrixed clinical science team; at Director level, guide and mentor junior team members.

Benefits

• Competitive remuneration packages, determined by role, employment location, and the selected candidate’s qualifications and experience.
• A variety of benefits intended to support employee wellbeing and a diverse employee base; availability, eligibility, and design may vary by location.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior