Executive Medical Director/VP of Clinical Development
Watertown, MA, United States
Executive Medical Director/VP of Clinical Development
Dragonfly Therapeutics seeks a knowledgeable, experienced and motivated individual to join our team and support clinical stage activities. Reporting to the Head of Clinical Development, this role will be responsible for developing and implementing strategies for efficient high-value clinical development of inflammation and immunology 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 a hands-on, clinical operations professional with extensive experience in clinical research who is nimble and thrives in a fast-paced, collaborative environment.
Responsibilities:
Lead the Clinical Development planning and strategy for Dragonfly's I&I portfolio
Lead and demonstrate ownership of early stage (phase 1-2) clinical trial design for novel, first-in-class immune engagers for treatment of inflammation and immunology
Write clinical trial synopsis and protocols and associated documents
In collaboration with the clinical operations team, contribute to selection of investigators and oversee project-related education of investigators, study site personnel, and study staff
Plan and direct all clinical aspects related to specific programs
Lead clinical study teams, monitor clinical trials (medical monitoring), and review, analyze, interpret, and communicate safety and efficacy data
Prepare 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 authoring 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 or lead clinical development contributions for due diligence or other business development activity
Qualifications: MD or MD/PhD, with at least 7-10 years successful track record in biotech or pharma in Medical Director roles in inflammation and immunology (title commensurate with experience)
Significant pharmaceutical drug development experience gained through front-line involvement in development of drugs to clinical PoC, and preferably to the market, in the US or EU
Ability to run a complex clinical research program with minimal direction
Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols
Preferred candidates have both significant clinical experience and a solid research background in inflammation or immunotherapy involving cytokines or other immune modulators
Proven leadership skills, work well with others, and ability to bring out the best in others on a cross- functional team; highly collaborative, team oriented and decisive
Excellent communication and presentation skills are essential
Willingness to travel to clinical sites and home office as required and necessary in support of the project(s)
Must live within driving distance of Waltham, and be willing to work on-site at 4 days/week
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.