Medical Director, Oncology

Position Title: Medical Director, OncologyIndustry: Pharmaceutical / Biopharmaceutical Location: Massachusetts
Position Number: 1790At Management Recruiters International—The Merwin Group, we specialize in the placement of outstanding talent in the pharmaceutical, biopharmaceutical and medical technology industries.Our expanding global client seeks to identify someone to provide medical and scientific input to early development projects, clinical development plans, business development activities and to assist in evaluations of new projects, whether coming from their own pipeline or from licensing activities. This is an expansion position with major responsibility and an opportunity for significant personal career growth.Primary Responsibilities:
Be the responsible trial director for WW Clinical (Phase I /POC, Phase II, III) Studies:
•Provide medical/scientific input and write relevant documents to ensure quality of study concept sheets, study protocols and reports, Investigators Brochures and other scientific documents.
•Review and sign off all documents related to the clinical studies (including study protocols and study reports).•Oversee all aspects related to the scientific and medical risks in collaboration with the safety representative
•Collaborate with CTM members in the selection of principal investigators and recruitment of clinical sites
•Lead the review, analysis and interpretation of study data
•Communication of study results when appropriate
Act as the leader or a member of a clinical team:•Propose Early and Full Clinical Development plans for assigned products to establish the safety and efficacy and support registration worldwide in the shortest possible time, in collaboration with clinical and project teams members.
•Review and/or write the clinical sections of the Common Technical Document and in particular the SCE / SCS (Summary of clinical efficacy and summary of clinical safety).
•Provide medical input to Pre-clinical Development in order to ensure that the pharmacology and biomarker plans are adequately supporting the early clinical development planClinical representative in project teams:•Participate in cross-functional project teams (development or research depending on the stage of project) to provide medical input into Product Development Plan or Preclinical Development Plans/ strategy
•Liaise with principal investigators, consultants, opinion leaders and academic institutions in the oncology area
•Provide input to Corporate Medical Information and Marketing to ensure the publication plans and publication contents are scientifically and medically valid and compatible with the strategic messages of the TA.•Support business development by providing scientific and medical input to in-licensing opportunities.•Increase scientific knowledge in the CDU and Clinical Research Unit by attending conference, international congresses. Assist in organizing scientific development activities within the TA, such as internal courses, inviting external speakers etc..•Support medical marketing activities, by providing specialist input in Phase IV clinical development Plans, pre and post launch activities, by attending conferences, contributing to the organization of cancer symposia and KOL development activities
REQUIREMENTS
Required Skills and Experience:
•M.D. specialized in an Oncology area of expertise, with at least 5 years experience in clinical Research and Development. Research/academic experience is welcome.•Experience in Pharmaceutical or Biotech) product development at the international level with experience in negotiations with global Health authorities (Europe , US and possibly Japan).
•Working knowledge in GCP and ICH guidelines/practices.
•Personal Skills and Competencies desired:
-Ability to work in a matrix environment.
-Excellent initiative and driven by the sense of the urgency.
-Strong communication skills (face-to-face, presentations, reports, etc.)
-Good selling and influential skills.
-Project Management capabilities.
-Entrepreneurial spirit and action/results driven.
-High-energy level person; a motivator.
-Willing to travel when necessary