Director, Clinical Science
BioPhase SolutionsSan Diego, CA, USjob_description.job_card.variable_days_ago
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job_description.job_card.job_descriptionAdvanced degree (e.g., PhD, MD, or equivalent) in a scientific or healthcare-related field preferred, with strong knowledge of clinical research and early-stage development. 7+ years of experience in clinical research, clinical science, or a related field. Thorough understanding of global regulatory standards, drug development processes, study design, statistics, and clinical operations. Proficiency in supporting program-specific data review, trend analysis, and data interpretation. Familiarity with establishing and managing data monitoring committees, dose review teams, and independent response adjudication groups.
Job Description
Job Description
Job Summary :
The Director, Clinical Science will provide scientific expertise to design and implement clinical research programs. This role collaborates with internal teams, external experts, advocacy groups, research organizations, study sites, and consultants to ensure scientific rigor in clinical initiatives.
Essential Duties and Responsibilities :
- Collaborate with external experts and internal research, clinical, and medical teams to develop clinical study designs and protocols.
- Contribute to statistical analysis plans and support the creation of study-related documents (e.g., consent forms, study manuals, data management plans, safety plans, protocol deviation plans).
- Work with clinical operations, data management, biostatistics, and safety teams to execute clinical studies and meet program objectives.
- Engage with study sites through activities such as training and serving as the primary contact for clinical inquiries.
- Support data generation and validation, including case report form (CRF) design, clinical data review, and query resolution to ensure high-quality data.
- Identify trends in clinical data and escalate questions to the appropriate medical oversight role.
- Develop and review clinical narrative plans and clinical narratives.
- Provide input for study budgets, research organization scopes of work, and related financial planning.
- Review and develop training materials for sites and research associates, present at site initiation and investigator meetings, and support study committee activities (e.g., data monitoring committees).
- Draft, review, and validate clinical study reports and clinical sections of regulatory documents (e.g., investigator brochures, safety updates, regulatory responses).
- Act as the primary liaison with external partners for scientific guidance.
Experience and Education Requirements :
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Director Clinical • San Diego, CA, US