Daiichi Sankyo US
Senior Director, Clinical Development - Hematology
The role provides medical accountability and oversight for one or more clinical trials within Global Oncology Clinical Development. It involves medical and scientific leadership across study design, clinical monitoring, data review, regulatory interactions, and cross-functional collaboration throughout Phase 1 to Phase 3 studies.
Key Responsibilities
- • 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 - Phase 3 studies (depending on assignment) with demonstrated decision-making capabilities
- • Provides medical and scientific expertise to cross-functional colleagues
- • Provides medical input on study and country feasibility, including site feasibility assessments
- • Contributes to eCRF design, UAT, and CRF Completion Guidelines as needed
- • Conducts ongoing clinical data review and assesses protocol deviations
- • Addresses medical queries from sites/IRBs, including eligibility, safety, dose modifications, and adverse event management
- • Serves as study medical expert and oversees CRO Medical Monitor activities, including data review and medical guidance (e.g., AE coding)
- • Leads development and execution of the Clinical Development Plan (CDP), ensuring alignment with protocols and Target Product Profile (TPP)
- • Provides medical/scientific leadership for study design, protocol development, and key study-level documents (e.g., CSR, IB, regulatory responses)
- • Interprets and presents clinical data to internal and external stakeholders; supports regulatory and safety reporting (e.g., DSUR, PSUR)
- • Delivers scientific training and leads key study meetings (e.g., IM, SIV) on compound, disease, and safety management
- • Maintains deep therapeutic area expertise and contributes to strategic insights on disease landscape, competition, and product positioning (TPP/EPP)
- • Leads engagement with governance bodies (e.g., DMC, Steering Committee), including charter development, presentations, and ongoing oversight
- • Oversees external partnerships (e.g., CROs, AROs, cooperative groups) and contributes to labeling and product lifecycle management
- • 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, if applicable, in planning and executing the overall publication and clinical communication strategy (overall or at the individual trial level), providing input to key external presentations
- • Contributes to and serves as the medical point of expertise in key Health Authority interactions and Ad board meetings
Required
- • MD required
- • Postgraduate training in TA or related specialty required
- • 7+ years relevant clinical experience required
- • Ability to travel up to 20% of the time
Preferred
- • Experience in Hematology preferred
At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.
Job Summary
The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to the effective strategy, design, execution, and interpretation of Oncology clinical trials.
Position Summary / Objective
Job Description
Medical Monitoring
Education Qualifications
Ability to travel up to 20% of the time.
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
Salary Range
USD$280,350.00 - USD$467,250.00
Job Summary
The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to the effective strategy, design, execution, and interpretation of Oncology clinical trials.
Position Summary / Objective
- 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 - Phase 3 studies (depending on assignment) with demonstrated decision-making capabilities
- Provides medical and scientific expertise to cross-functional colleagues
Job Description
Medical Monitoring
- Provides medical input on study and country feasibility, including site feasibility assessments
- Contributes to eCRF design, UAT, and CRF Completion Guidelines as needed
- Conducts ongoing clinical data review and assesses protocol deviations
- Addresses medical queries from sites/IRBs, including eligibility, safety, dose modifications, and adverse event management
- Serves as study medical expert and oversees CRO Medical Monitor activities, including data review and medical guidance (e.g., AE coding)
- Leads development and execution of the Clinical Development Plan (CDP), ensuring alignment with protocols and Target Product Profile (TPP)
- Provides medical/scientific leadership for study design, protocol development, and key study-level documents (e.g., CSR, IB, regulatory responses)
- Interprets and presents clinical data to internal and external stakeholders; supports regulatory and safety reporting (e.g., DSUR, PSUR)
- Delivers scientific training and leads key study meetings (e.g., IM, SIV) on compound, disease, and safety management
- Maintains deep therapeutic area expertise and contributes to strategic insights on disease landscape, competition, and product positioning (TPP/EPP)
- Leads engagement with governance bodies (e.g., DMC, Steering Committee), including charter development, presentations, and ongoing oversight
- Oversees external partnerships (e.g., CROs, AROs, cooperative groups) and contributes to labeling and product lifecycle management
- 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, if applicable, in planning and executing the overall publication and clinical communication strategy (overall or at the individual trial level), providing input to key external presentations.
- Contributes to and serves as the medical point of expertise in key Health Authority interactions and Ad board meetings
Education Qualifications
- MD required
- Postgraduate training in TA or related specialty required
- 7+ years relevant clinical experience required
- Experience in Hematology preferred.
Ability to travel up to 20% of the time.
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
Salary Range
USD$280,350.00 - USD$467,250.00
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