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Medical Director Oncology Hematology
Thor CompaniesBoston, MA, US30+ days ago
Job type
- Full-time
Job descriptionClinical Development Strategy and Execution Provide medical and strategic leadership for all clinical related initiatives including supporting regulatory interactions working closely with regulatory affairs and key cross-functional representatives Develop and lead presentation for internal governance meetings to support timely and efficient decision making Liaise with the DMPK colleagues to understand PK modelling application for dosing / schedule recommendations Perform literature searches and support data generation plan including key publications Support Business Development evaluations of promising late stage assets under consideration for in-licensing / acquisitions Medical Monitor Leads the design and the execution of clinical trials, ensuring they align with regulatory requirements and company objectives Provide medical monitoring oversight for clinical studies in accordance with GCP Participate in key review of data for critical clinical and / or safety endpoints and medical literature to evidence-based decision-making and communication Team collaboration : Working closely with cross-functional teams, including the asset team, clinical sub-team, regulatory affairs, medical affairs, and commercial teams, to ensure alignment and successful product development KOL engagement, Investigatory led studies, and publication support Support interactions with KOLs and development of advisory board content Other duties as required or directed by the Manager or Functional Management M.D. required with a strong preference for specialty training and board certification in Medical Hematology / Oncology. Experience with Acute Lymphoblastic Leukemia is required 3+ years in industry with strong preference for regulatory interactions experience. Demonstrated ability to lead clinical development efforts across phases of development within the Hematology / Oncology space. Excellent public speaking, writing, and communication skills required. Ability to teach and mentor is also critical and work in a cross-functional collaborative way. Problem solving mindset with the ability to be creative and to execute a vision that seeks to drive innovation Ability to organise and prioritise workstreams and guide teams through challenges Excellent operational execution and ability to meet critical timelines Team player who has strong matrix working capability. Proven track record practicing sound medical judgment as it relates to clinical acumen and risk assessment including but not limited to leading cohort safety evaluation meetings in early phase studies, co-authoring investigator brochures, providing clinical expertise on PV related documents. Core Competencies : Leadership, Execution, Strategy, Collaboration.
This is a hybrid role on-site in Boston Massachusetts. Candidates must be local to the Boston area.
Key program deliverables include :
- Provide clinical expertise in ALL (adult and pediatric) to support completion of ongoing study (e.g. CSR)
- Provide strategic and clinical insights for data generation and potential new study designs
- Work collaboratively in cross-functional working group to deliver a strategic plan for internal governance decision making prior to year end
- Support regulatory interaction preparations in the event of a new sponsored study
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Hematology Oncology Medical Director • Boston, MA, US
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