Meet is partnered with a cutting-edge biopharmaceutical company on their mission to treat cancer. They are a team of passionate individuals who are committed to making a meaningful impact on healthcare, and are seeking a Senior Director, Clinical Scientist to join their growing team. The Senior Director, Clinical Science will play a pivotal role in shaping the scientific, clinical, and operational aspects of clinical development programs, with a focus on program-specific initiatives. This role involves leading the design, planning, and execution of study protocols for investigational products while supporting related regulatory activities. The individual will collaborate with cross-functional teams to manage clinical trials, interpret data, and communicate findings to internal and external stakeholders. Additionally, this position may contribute to process improvement initiatives within the clinical department.
Key Responsibilities
Partner with cross-functional teams to oversee clinical study conduct, including operational feasibility, data management deliverables, communication plans, safety and medical monitoring, and study close-out activities.
Perform medical and safety/efficacy data reviews, including gathering, analyzing, interpreting, and providing preliminary assessments and recommendations. Analyze protocol-related issues and assess individual subject safety.
Support Data Monitoring Committees and other data review committees, including operationalizing charters, preparing updates, and synthesizing data reports for decision-making.
Author clinical protocols and contribute to related documentation such as study reports, investigator brochures, informed consent forms, training materials, and regulatory submissions.
Engage with internal and external stakeholders (study sites, vendors, committees) to align program-level development strategies and clinical trial objectives.
Represent the clinical team as a subject matter expert for assigned programs.
Develop and review scientific materials, including abstracts, posters, and presentations for conferences. Collaborate on publication strategies with investigators and stakeholders.
Conduct literature reviews to support clinical and scientific objectives.
Provide mentorship and line management for junior clinical scientists.
Qualifications
Advanced degree (PhD, PharmD, MD, or equivalent) in a health sciences field.
12+ years of experience in a clinical science or related role within the pharmaceutical, biotechnology, or CRO industry.
Expertise in oncology or oncology immunotherapy clinical trials is required.
Proven experience in late-stage drug development and regulatory submissions (e.g., BLA/NDA).
Familiarity with renal cell carcinoma clinical studies is a plus.
Strong experience with data analysis, interpretation, and safety principles in clinical research.
Ability to evaluate complex scientific data and integrate findings into program strategies. Working knowledge of biostatistics, GCP, and regulatory guidelines.
Excellent organizational skills and the ability to manage multiple projects in a dynamic environment.
Strong interpersonal, verbal, and written communication skills.
Demonstrated ability to work effectively in a fast-paced, matrixed team environment while functioning independently when needed.
Full job description and company details are available upon application. This position is being dealt with by Payton Baker at Meet, please email payton.baker@meetlifesciences.com if you would like to discuss more about this opportunity in confidence.