Clinical Research Director

4 weeks ago


Watertown, Massachusetts, United States Dragonfly Therapeutics, Inc. Full time
Job Title: Director, Clinical Research Scientist

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.
Qualifications:
  • 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.
About Dragonfly Therapeutics:

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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