Clinical Research Director
4 weeks ago
Dragonfly Therapeutics is seeking a highly skilled Clinical Research Scientist to lead the implementation, planning, and execution of clinical trial activities. As a key member of our clinical development team, you will be responsible for delivering high-quality trial execution, investigator engagement, data review, safety assessment, and interpretation of clinical study results.
Key Responsibilities:- Provide scientific leadership and execution of clinical studies, including innovative clinical study designs and high-quality trial execution.
- Lead clinical development functional activities and collaborate with clinical operations in the implementation of clinical study startup/conduct/close-out activities.
- Contribute to protocol development, including writing, reviewing, and aligning cross-functional comments to ensure high clinical quality.
- Maintain a thorough understanding of protocols and protocol requirements, educating team members and responding to site questions.
- Serve as a technical resource for clinical issues raised by internal and external collaborators, investigators, consultants, and contractors.
- Conduct and oversee activities related to data generation and validation, including clinical data review and query resolution.
- Identify clinical data trends and provide insights to the Clinical Research Physician.
- Author and review clinical portions of Regulatory Documents, including clinical study reports, Investigator Brochures, and briefing documents.
- Provide Clinical Science input to proposed revisions of SOPs and Guidance documents.
- Participate in the planning and development of publications, abstracts, and presentations.
- PhD/PharmD and 3-5+ years of experience in clinical development, with a proven track record of executing oncology or immuno-oncology development programs to completion or targeted milestone.
- Proficient knowledge of drug development process, study design, response assessment criteria, statistics, and clinical operations.
- Excellent leadership and project management skills, with the ability to prioritize multiple tasks and goals and deliver them in a timely, on-target, and high-quality manner.
- Strong interest in process improvement projects and excellent interpersonal, verbal communication, and influencing skills.
- Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate.
Dragonfly Therapeutics is a clinical-stage biopharmaceutical company committed to discovering, developing, and commercializing therapies that use its novel multispecific antibody technology to harness the body's immune system to bring breakthrough treatments to patients.
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