Senior Director, Clinical Science - Oncology

BioNTech IMFS; Cambridge (MA); On-site; USD 120,000 - 220,000; Full time

Job summary

An established industry player is seeking a Senior Director of Clinical Science to lead oncology clinical trials. This pivotal role involves designing clinical studies, ensuring compliance with regulatory standards, and managing cross-functional teams to evaluate investigational drugs' safety and efficacy. The ideal candidate will have over 12 years of experience in the pharmaceutical industry, a strong background in oncology, and proven leadership skills. Join a dynamic team that values innovation and collaboration, where your expertise will directly impact the advancement of groundbreaking therapies in cancer treatment. This is an exciting opportunity to shape the future of clinical science in a rapidly evolving field.

Qualifications

• 12+ years of experience in clinical science and drug development.
• Strong knowledge of GCP and global clinical study execution.

Responsibilities

• Develop clinical trial designs and protocols in collaboration with teams.
• Oversee clinical trial data review and ensure compliance with regulations.

Skills

Clinical Trial Design

Good Clinical Practice (GCP)

Oncology Knowledge

Data Analysis

Team Management

Regulatory Compliance

Communication Skills

Project Management

Education

PhD in Life Sciences or related field

Master's in Clinical Research

Tools

EDC systems

Excel

Job description

Senior Director, Clinical Science - Oncology

Cambridge, US; Gaithersburg, US; New Jersey, US | full time | Job ID:8979

Responsibilities:

• In collaboration with the Clinical Development Lead, develop the design of clinical trials to evaluate the safety and efficacy of investigational drug. This includes developing the study protocol, identifying patient populations, and selecting study endpoints.
• Support the Clinical Development Lead in the medical 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.
• Build and foster relationships with PIs and Key Opinion Leaders (KOLs) in relevant therapeutic areas.
• Develop training materials to support the understanding of the clinical trial protocol and/or disease indication. Provide training to study team members, CRO staff, investigator staff, etc.
• Present at key meetings (e.g. SIVs, investigator meetings, IDMC meetings, 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.
• Oversee the medical data review and analysis of clinical trial data across a platform/indication/asset to evaluate the safety and efficacy of investigational drugs. This includes working with biostatisticians to develop analysis plans, reviewing study data, and interpreting study results. Work to improve the quality of reviews/ insights with an emphasis on subject safety and eligibility, data integrity, trend identification, analysis and remediation.
• 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.
• Line management of clinical science personnel inclusive of development, coaching, performance evaluations, etc.

Qualifications:

• 12+ years of industry experience
• Prior experience managing a team
• 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)