Director Oncology R&D
3 days ago
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Job Summary:Serves as a primary source of medical accountability and oversight for one or more clinical trials. Matrix management responsibilities across the internal and external network. Manages Phase 1-3 studies (depending on assignment) with demonstrated decision-making capabilities. Provides medical and scientific expertise to cross-functional DSI colleagues.
Medical Monitoring:
- For studies in which Medical Monitoring activities are conducted in-house:
- Provides medical input regarding country feasibility. Consulted on decisions related to clinical trial feasibility and contributes to the site feasibility assessment from a physician's perspective
- May provide clinical input into the eCRF (Case Report Form) design, participate in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) review
- Conducts clinical data review per Integrated Data Review Plan (IDRP)
- Accountable for the assessment of protocol deviations
- Discusses medical eligibility questions and answers safety questions (dose modifications, discontinuations, and management of adverse events)
- May participate in Site Initiation Visit (SIV) and conduct medical monitoring visits at any time during the conduct of the study to provide medical input
- Provides medical guidance for coding of AEs, medical history, and medications when needed
- Addresses medical questions directly from sites/ Institutional Review Boards (IRBs), and other site personnel as needed
- Study-specific subject matter expert (SME) for internal audit or Health Authority (HA) questions related to medical monitoring
- For studies in which Medical Monitoring activities are conducted by the Contract Research Organization (CRO) Medical Monitor (MM):
- Provides oversight to the CRO MM for clinical data review activities
- May support addressing eligibility and medical questions from sites/ IRBs
- May provide medical guidance for coding of AEs, medical history, and medications when needed
- May contribute to addressing questions about medical decisions, clinical data review, protocol deviations, etc., and/or scientific aspects of the study during FDA, MHRA, EMA, and PMDA interactions, such as pre-submissions, end of phase 1/2, and inspections
- May support the GCL in planning and executing the overall publication and clinical communication strategy (overall or at the individual trial level), providing input to key external presentations, if applicable.
- Contributes to and serves as the medical point of expertise in key HA interactions and Ad board meetings
Education:
- MD or equivalent required and
- Postgraduate training in TA or related specialty preferred Experience Qualifications
- 4 or More Years industrial experience required
Travel:
- Ability to travel up to 20% Domestic and International travel will be required.
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