What are the responsibilities and job description for the SENIOR DIRECTOR, CLINICAL RESEARCH SCIENTIST position at Dragonfly Therapeutics?
Senior Director, Clinical Research Scientist
Dragonfly Therapeutics is seeking a Clinical Research Scientist with a strong scientific background in I&I / Autoimmune Disease. This position will report to the Clinical Development Lead for I&I, and be responsible for the implementation, planning, and execution of assigned clinical trial activities. They will lead, plan, and execute study-level activities for 1 or more trials, and interact with Translational Scientists, Project Leadership, Safety, Regulatory, Data Management, Biostats, other Clinical Research Scientists (Oncology) and Clinical Operations to drive Clinical Development strategy, design, execution, and interpretation of clinical trial data. The successful candidate will excel in a highly dynamic and collaborative work environment with a multi-disciplinary and diverse team, focusing on multiple programs in parallel. The work will be fast paced with evolving needs, requiring adaptability, curiosity, and grace under pressure.
Responsibilities (including but not limited to) :
- Responsible for scientific leadership and execution of clinical studies and delivering on innovative clinical study designs, high quality trial execution, investigator engagement, data review, safety assessment, and interpretation of clinical study results
- 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 with minimal guidance (includes writing, reviewing, aligning cross functional comments, and ensuring high clinical quality in collaboration with Medical Writing / Regulatory)
- Maintain a thorough understanding of protocols and protocol requirements; educate team members and respond to site questions
- Serve as 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; ensure consistent, quality data review, protocol deviation review, and coding review.
- Identify clinical data trends; provide trends and escalate questions to Clinical Research Physician
- Author / review clinical portions of Regulatory Documents, including clinical study reports (CSRs), Investigator Brochures, 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
- Be a role model for a culture of transparency, collaboration, and open communication
Qualifications
About Dragonfly
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. In addition to its wholly owned clinical assets, Dragonfly has a deep pipeline of wholly owned preclinical candidates discovered using its proprietary platform, as well as productive collaborations with Merck, AbbVie, Gilead and Bristol Myers Squibb in a broad range of disease areas.
Our mission is to revolutionize disease treatment by inventing natural killer cell-based therapies for vastly improved patient outcomes. We believe in a small team with a big impact.
