What are the responsibilities and job description for the Executive Medical Director/VP of Clinical Development position at Dragonfly Therapeutics, Inc.?
Executive Medical Director / VP of Clinical DevelopmentDragonfly Therapeutics seeks 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 (including but not limited to) : Contribute to early stage (phase 1-2) clinical trial design for novel, first-in-class tri-specific antibodies or cytokine programs for treatment of cancerWrite clinical trial synopsis and protocols and associated documentsIn 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 staffSupport all clinical aspects related to specific programsSupport clinical study teams, monitor clinical trials (medical monitoring), and review, analyze, interpret, and communicate safety and efficacy dataContribute to clinical reports and publicationsPresent at scientific and medical advisory board meetings and at regulatory meetingsDevelop and maintain cross-functional relationships with academic investigators, pharmaceutical partners / sponsors, CROs, KOL's, and patient advocacy groupsContribute to company's planned regulatory filings including drafting clinical sections for INDs and other related documentsMaintain 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 stakeholdersMaintain ethical standards of the highest level and have the knowledge and ability to comply with all relevant ethical, regulatory, and legal standardsParticipate in clinical development contributions to due diligence or other business development activityAs required by program needs, contribute in partnership with Discovery and Translational Medicine colleagues to the design and implementation of translational strategiesQualifications : MD (hematology / oncology) or MD / PhD (hematology / oncology) with at least 7-10 years successful track record in biotech or pharma in Medical Director roles in oncology and cancer immunotherapy (title commensurate with experience)Pharmaceutical drug development experience gained through front-line involvement in development of IO drugs to clinical PoC, and preferably to the market, in the US or EUAbility to learn and to support complex clinical research programs with minimal directionKnowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocolsPreferred candidates have both clinical experience and a research background in hematology / oncology, immunology or immunotherapy involving cytokines or other immune modulatorsAbility to work well with others, and to bring out the best in others on a cross-functional team; highly collaborative, team oriented and decisiveExcellent communication and presentation skills are essentialWillingness to travel to clinical sites and home office as required and necessary in support of the project(s)About DragonflyDragonfly 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.
