Director/Senior Director, Clinical Research Scientist
2 weeks ago
Dragonfly Therapeutics seeks a Clinical Research Scientistwith a strong scientific background in Oncology, Immunology, or Immuno-oncology. This position will report to the VP of Clinical Development 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, 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:
- 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 (including protocol documents and amendments) 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 and 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
- Review information for development of trial budget, CRO scope of work, etc.
- Author/review clinical study reports (CSRs), and clinical portions of Regulatory Documents
- Conduct data review, analyses, and interpretation of clinical trials data together with the GDL, Clinical Safety, and Biostatistics.
- 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:
- PhD/PharmD and 5+ years; MA/MBA/MS and 7+ years; BA/BS/BSN and 10+ years of experience in clinical development. 3-5+ years of clinical scientist experience with a proven track record executing oncology or immuno-oncology development programs to completion or targeted milestone; Phase I/IB experience a plus.
- Experience working with the principles and techniques of data review, data analysis plan and interpretation, and assessment of clinical relevance
- Proficient knowledge of drug development process, study design, response assessment criteria, statistics, and clinical operations
- Proficient knowledge and skills to support program specific data review, trend identification, and data interpretation
- Excellent leadership and project management skills; able to prioritize multiple tasks and goals and deliver them in a timely, on-target, and high-quality manner within budget guidance
- Strong interest in process improvement projects with skills in metrics and dashboard creation
- Excellent interpersonal, verbal communication, and influencing skills; can influence without authority and has proven experience building and cultivating relationships with key partners and stakeholders both internally and externally
- Strong presentation skills; effective at summarizing and presenting the key considerations and decision-points
- Excellent teamwork and negotiation skills; able to complete deliverables by working effectively with others internally and externally and can effectively drive discussions and decisions toward desired end-results
- Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate
- Domestic and international travel as needed
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.
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