Sr. Director, Experimental Medicine at Edison

Job Description

Job Summary: We are currently seeking a Senior Director, Experimental Medicine Oncology / Immunology / Infectious Disease (OII)in our Edison, NJ location. This position is the Oncology lead for Experimental Medicine (early) drug-development group, within Translational Medicine and Clinical Pharmacology (TMCP) function.Responsibilities:In this position, you will within a global matrix environment, directly run, oversee conduct of, or provide strategic/medical input into first-in-human and Phase 1 oncology drug-development trials/programs.Position oversees early activities in the US; liaise with regional R&D groups in Japan and Europe, and with colleagues responsible for later phase clinical development.Scope includes coverage for projects in preclinical stages and IND support.Position requires an emphasis on mechanistic studies; compounds to be studied include both small molecules and biologics.Serve as the principal medical resource for oncology and cancer therapeutics, within the global Translational Medicine and Clinical Pharmacology function.In this capacity, the position is expected to lead and/or otherwise make substantial contributions to early development planning for oncology-candidate compounds.Across an oncology portfolio, play a key/lead role in developing biomarker identification and related strategies, and in setting stages for personalized drug development to include companion diagnostics.Identify consultants to aid early development programs; serve as the main company contact in establishing and maintaining selected external collaborations in cancer biology, oncology and personalized medicine.Lead selected non-product clinical studies or other exploratory efforts to support biomarker development and validation.Serve as medical monitor for Phase 1 clinical trials, primarily in oncology (with ability to cover other therapeutic areas, should the need arise).Manage hiring, performance and development of reporting staff. Coordinate with logistics, operations and outsourcing groups to plan and manage budgets, contracts and outsourcing vendor selection.Represent the Translational Medicine and Clinical Pharmacology function in meetings with regulators, in regards to oncology development programs.Support business development planning and opportunity (e.g., in-licensing) assessments in the area of oncology.

Job Requirements

M.D.7+ years academic or pharmaceutical industry experience in experimental medicine, translational medicine or clinical pharmacology with extensive experience in oncology therapeutics.Solid understanding of basic research methodologies (molecular biology techniques) and data interpretation. Experience in directing Phase I programs. Demonstrated experience in and strong ability to coordinate multiple projects.Able to lead functional area as well as multifunctional teams related to development of pharmaceutical products.In depth knowledge of Experimental Medicine, Clinical Pharmacology and related approaches to oncology drug development. In depth knowledge of drug development processes, clinical trial processes and registrational processes. Understanding of role of biomarkers to confirm pharmacologic activity, provide evidence for clinical efficacy, optimize dosing regimens and identify appropriate patients for clinical trials. Knowledge of strategic outsourcing activities to CROs. Ability to manage budget and human resources effectively to achieve goals.US Board Eligible or Certified in Oncology; qualified to hold a US-state medical license.Cultural sensitivity and ability to influence outside of formal reporting lines. Must be willing to travel 20% of the time
Country: USA, State: New Jersey, City: Edison, Company: Daiichi Sankyo, Inc..