Daiichi Sankyo US
Executive Director, Global Clinical Lead
Oversees multiple programs, alliances, and large clinical trials, including global clinical development programs for multiple product candidates or large Phase II/III study programs. Provides senior-level clinical representation with health authorities, leads developmental and regulatory strategy, and supports clinical development input into commercial strategy, Translational Medicine, biomarker strategy, and business development decisions.
Key Responsibilities
- • Oversees and coordinates Sponsor oversight of CRO clinical Monitoring activities, including plan for internal communication and issue escalation with Clinical Study Lead (CSL)
- • Documents ongoing Clinical Monitoring review of data for safety (with Clinical Safety Pharmacovigiliance) and quality at project level
- • Ensures global consistency of clinical Monitoring activities
- • Defines or contributes to department level surveillance activities across projects
- • Interacts with leaders of each function to develop study strategy
- • Approves project or TA-level TM and biomarker strategy in collaboration with Translational Medicine and Clinical Pharmacology
- • Attends regulatory agency meetings and leads clinical strategy discussions
- • Develops prospective contingency plans for management of key risks across a large project or a portfolio of projects or across the Therapeutic Area
- • Clearly defines priorities and high level execution plans across projects within and outside of Daiichi Sankyo
- • Supports effective communication and decision-making process cross-functionally and cross-regionally at department level
- • For large-studies/programs, consults on responses to IRBs and HA
- • Has strong understanding of statistics and study design principles applicable to primary and efficacy and safety endpoints in registrational trials to critically assess study conclusions
- • Ensure continuous, effective alignment within / between CRO and vendors
- • For large, multiple indication project in late development, develops and leads Ad-Board with top tier KEEs for project level strategic advice
- • Develops and leads steering committee for Phase 3 registrational study
- • Consults with KEEs for advice on complex development or safety issues
- • Maintains and leads external collaborations and advisory panels at department level
- • Assign staff with appropriate training and experience or arrange requisite support to lead large study teams, coordinate complex studies, lead projects, and/or ensure proper medical oversight
- • Monitor and manage direct report’s performance in such roles, ensuring that there is proper understanding of task complexity and management of key risks
- • Participate in department’s planning for staff and cross-functional staffing plans for the Therapeutic Area
- • Routine senior management interactions
- • Influential relationship with top KOLs
- • Thought partner with Ext Scientific Affairs on Business Development activities for late stage compounds
- • Committee member, in-licensing and acquisitions
Required
- • MD with relevant clinical experience required
- • Postgraduate training in TA or related specialty required
- • 7+ years experience in clinical development required
- • 4+ years managing Clinical Development group required
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
Oversees multiple programs, alliances, large trials, such as global clinical development program for multiple product candidates with one or more indications or a single large program with multiple Ph II/III studies; Reviews regulatory documents from cross functional, holistic perspective. Provides senior level clinical representation at meetings with health authorities; Leads the creation of developmental and regulatory strategy; Accountable for performance of CROs; Routine interactions with senior management of CRO/ARO, as needed; Accountable for clinical development plans, protocol profiles and sections of key submission documents; Represents Clinical Development as team leader or as supervisor of team leaders; Accountable for Clinical Development input into commercial strategy including Translational Medicine and biomarker strategy; Thought partner in driving Business Development decisions in collaboration with External Scientific Affairs dept.
Responsibilities
Job Description
Education Qualifications
Salary Range
USD$329,025.00 - USD$548,375.00
Job Summary
Oversees multiple programs, alliances, large trials, such as global clinical development program for multiple product candidates with one or more indications or a single large program with multiple Ph II/III studies; Reviews regulatory documents from cross functional, holistic perspective. Provides senior level clinical representation at meetings with health authorities; Leads the creation of developmental and regulatory strategy; Accountable for performance of CROs; Routine interactions with senior management of CRO/ARO, as needed; Accountable for clinical development plans, protocol profiles and sections of key submission documents; Represents Clinical Development as team leader or as supervisor of team leaders; Accountable for Clinical Development input into commercial strategy including Translational Medicine and biomarker strategy; Thought partner in driving Business Development decisions in collaboration with External Scientific Affairs dept.
Responsibilities
Job Description
- Clinical Monitoring Planning: Oversees and coordinates Sponsor oversight of CRO clinical Monitoring activities, including plan for internal communication and issue escalation with Clinical Study Lead (CSL)
- Clinical Surveillance: Documents ongoing Clinical Monitoring review of data for safety (with Clinical Safety Pharmacovigiliance) and quality at project level; Ensures global consistency of clinical Monitoring activities; Defines or contributes to department level surveillance activities across projects
- Study strategy: Interacts with leaders of each function to develop study strategy; Approves project or TA-level TM and biomarker strategy in collaboration with Translational Medicine and Clinical Pharmacology; Attends regulatory agency meetings and leads clinical strategy discussions
- Study planning and execution: Develops prospective contingency plans for management of key risks across a large project or a portfolio of projects or across the Therapeutic Area; Clearly defines priorities and high level execution plans across projects within and outside of Daiichi Sankyo; Supports effective communication and decision-making process cross-functionally and cross-regionally at department level
- Study Outputs: For large-studies/programs, consults on responses to IRBs and HA; Has strong understanding of statistics and study design principles applicable to primary and efficacy and safety endpoints in registrational trials to critically assess study conclusions
- External collaboration: Ensure continuous, effective alignment within / between CRO and vendors; For large, multiple indication project in late development, develops and leads Ad-Board with top tier KEEs for project level strategic advice; Develops and leads steering committee for Phase 3 registrational study; Consults with KEEs for advice on complex development or safety issues; Maintains and leads external collaborations and advisory panels at department level
- People Management: Assign staff with appropriate training and experience or arrange requisite support to lead large study teams, coordinate complex studies, lead projects, and/or ensure proper medical oversight; Monitor and manage direct report’s performance in such roles, ensuring that there is proper understanding of task complexity and management of key risks; Participate in department’s planning for staff and cross-functional staffing plans for the Therapeutic Area.
- Additional Non-Study related activities: Routine senior management interactions; Influential relationship with top KOLs; Thought partner with Ext Scientific Affairs on Business Development activities for late stage compounds; Committee member, in-licensing and acquisitions
Education Qualifications
- MD with relevant clinical experience required
- Postgraduate training in TA or related specialty required
- 7+ years experience in clinical development required
- 4+ years managing Clinical Development group required
Salary Range
USD$329,025.00 - USD$548,375.00
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