What are the responsibilities and job description for the DIRECTOR / SR. DIRECTOR OF CLINICAL DEVELOPMENT position at Dragonfly Therapeutics?
Dragonfly Therapeutics is seeking a knowledgeable, experienced, and motivated individual to join our team and support clinical stage activities. Reporting to the Head of Development, this role will be responsible for working closely with the Asset Lead, to develop and implement strategies for efficient high-value clinical development of cancer immunotherapy drug candidates, leading to clinical proof of concept. He / she will also be responsible for planning, managing, coordinating and tracking all clinical activities associated with specific clinical development programs for novel drug candidates. Must be hands-on, clinical operations professional with experience in clinical research who is nimble, eager to learn, and thrives in a fast-paced, collaborative environment.
Responsibilities :
- Contribute to early stage (phase 1-2) clinical trial design for novel, first-in-class tri-specific antibodies or cytokine programs for treatment of cancer
- Write clinical trial synopsis and protocols and associated documents
- In collaboration with the clinical operations team, contribute to selection of clinical sites, investigators and support project-related education of investigators, study site personnel, and study staff
- Support all clinical aspects related to specific programs
- Support clinical study teams, monitor clinical trials (medical monitoring), and review, analyze, interpret, and communicate safety and efficacy data
- Contribute to clinical reports and publications
- Present at scientific and medical advisory board meetings and at regulatory meetings
- Develop and maintain cross-functional relationships with academic investigators, pharmaceutical partners / sponsors, CROs, KOL's, and patient advocacy groups
- Contribute to company's planned regulatory filings including drafting clinical sections for INDs and other related documents
- Maintain a high level of clinical and scientific expertise in the disease area(s) by reviewing the literature, attending medical / scientific meetings, and through personal interchanges with consultants, thought leaders, investigators and internal stakeholders
- Maintain ethical standards of the highest level and have the knowledge and ability to comply with all relevant ethical, regulatory, and legal standards
- Participate in clinical development contributions to due diligence or other business development activity
- As required by program needs, contribute in partnership with Discovery and Translational Medicine colleagues to the design and implementation of translational strategies
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.
