Sr. Director, Medical Director

Company: Fusion Pharmaceuticals
Location: Providence
Posted on: August 4, 2022

Job Description:

Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Employing a proprietary Fast-Clear linker technology, Fusion connects alpha particle emitting isotopes to various targeting molecules in order to selectively deliver the alpha emitting payloads to tumors.Fusion's lead program, FPI-1434 targeting insulin-like growth factor 1 receptor, is currently in a Phase 1 clinical trial. The pipeline includes FPI-1966 targeting the fibroblast growth factor receptor 3 (FGFR3) and FPI-2059, a small molecule recently acquired from Ipsen, targeting neurotensin receptor 1 (NTSR1). In addition to a robust proprietary pipeline, Fusion has a collaboration with AstraZeneca to jointly develop up to three novel targeted alpha therapies (TATs) and explore up to five combination programs between Fusion's TATs and AstraZeneca's DNA Damage Repair Inhibitors (DDRis) and immuno-oncology agents. Fusion also entered into a collaboration with Merck to evaluate FPI-1434 in combination with Merck's KEYTRUDA (pembrolizumab) in patients with solid tumors expressing IGF-1R.The Medical Director will report to the Head of Clinical Development and be responsible for assisting with the advancement of specific radiopharmaceutical oncology programs by devising clinical development strategies and by serving as a representative for Clinical to project-specific Development Teams. In addition, the Medical Director serves as the Medical Monitor for ongoing clinical trials in assigned trials, ensuring compliance with ICH/GCP and federal regulations. Responsibilities: Provide Medical and Clinical Development expertise and leadership to assigned clinical development programsDesign and draft protocol synopses, clinical trial protocols and protocol amendments, and contribute to various regulatory documents, IBs, INDs and DSURsProvide medical oversight of multiple clinical studies and provide medical input and guidance on scientific, clinical and safety monitoring issuesPartner with Clinical Operations and provide leadership and direction to clinical project teamsEstablish and maintain positive relationships with clinical trial investigators/physicians, KOLs and clinical advisors through independent collaborations and scientific meetingsProvide strategic input on compounds in development and propose clinical development strategiesProvide medical expertise as needed for business development initiativesProvide medical and scientific expertise to preclinical discovery groups for compounds that are in preclinical development Education and Skills Requirements: MD, subspecialty training in oncology/hematology is preferred3+ years of hands on pharmaceutical or biotech experience in clinical development within OncologyExperience leading oncology early clinical development programs and working with discovery, preclinical, translational and external collaboratorsPrior managerial experience including direct oversight of MDs and Clinical Scientists is preferredIn-depth knowledge of the drug development process and oversight of clinical trialsWorking knowledge of biostatistics, regulatory requirements, clinical pharmacology and pharmacokineticsPrior interaction with Regulatory authorities and drafting of regulatory-related documentsPrior experience developing radiopharmaceuticals and/or antibody drug conjugates is a plusExcellent interpersonal, written, and verbal communication skillsProven ability to successfully manage multiple tasks and prioritize accordinglyProfessional and pleasant demeanorThis is a Boston based positionWillingness to travel All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
PDN-96755f54-3c45-4044-9dfe-c96cfb40d9db

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