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Check out JobsAIAssociate Director / Director of Clinical Sciences
Comp: 200 - 260k
Position Overview
The individual in this leadership role will apply scientific expertise to the planning and execution of clinical research initiatives. They will collaborate closely with internal stakeholders, external advisors, research partners, and clinical sites to ensure robust scientific foundations across all aspects of the clinical development program.
Key Responsibilities
- Work with internal teams and external experts to shape clinical study protocols and research designs.
- Contribute to statistical planning and the creation of study-related materials (e.g., consent forms, data management frameworks, safety procedures).
- Partner with cross-functional teams—including clinical operations, biostatistics, and safety monitoring—to deliver trials that meet program objectives.
- Engage with research sites to provide training and act as a central contact for scientific and clinical inquiries.
- Oversee clinical data activities such as case report form (CRF) development, data integrity checks, and resolution of discrepancies to ensure consistency and quality.
- Identify data trends and collaborate with medical oversight to assess potential issues or emerging patterns.
- Lead or support the preparation and review of patient narratives and relevant study documentation.
- Supply clinical input to trial budgeting, vendor scopes, and operational planning.
- Review and support the development of investigator and site training materials, and participate in study meetings and advisory boards as needed.
- Draft and validate final study reports and contribute clinical content for regulatory documents and submissions.
- Serve as the primary scientific point of contact for external collaborators.
Background and Qualifications
- Advanced academic credentials (e.g., PhD, MD, or PharmD) in a life sciences field are strongly preferred.
- A minimum of 8 years of experience in clinical science, clinical development, or a related area.
- Solid understanding of clinical trial processes, ethical guidelines (GCP/ICH), data evaluation, and protocol development.
- Demonstrated ability to evaluate and interpret clinical data and contribute to data-driven decision making.
- Familiarity with oversight structures such as data monitoring boards and adjudication panels.