Job Responsibilities
- Ensure ongoing review and alignment of therapy area strategy and associated documents before governance approval.
- Oversee development and execution of the Integrated Disease Area Strategy (IDAS) and Integrated Global Development Plan (IGDP).
- Review synopses, clinical study documents, and critical study results; provide leadership and oversight of clinical development activities.
- Manage study physician(s) and/or clinical scientist(s) leads for conduct and data review; proactively identify contingencies, risks, and mitigation strategies.
- Direct development strategy and deliverables (Development Strategy, Clinical Development Plan, Clinical Protocols), including scope/complexity/size recommendations that influence program budgets.
- Conduct critical evaluation of development strategy to maintain regulatory-aligned, state-of-the-art plans; develop contingency plans.
- Make high-impact global decisions from internal/external data (e.g., go/no-go; modifications to plans or study designs affecting timelines/labeling).
- Plan clinical development strategies considering medical/clinical significance, fit with current treatments/standard of care, and unmet need.
- Ensure regional strategies and trade-offs are documented and stakeholders are briefed.
- Provide strategic input for global development (all compounds in OTAU) and support evaluation of external compounds (alliances/in-licensing).
- Serve as primary interface with Medical Affairs; contribute to regional KOL network; recommend GDT leader nominations/reviewers for external compounds.
- Coordinate with Clinical Operations and Project Management for logistics study planning/implementation.
- Review safety information with Pharmacovigilance and Medical Monitor of Record.
- Lead clinical science interactions with FDA/other regulators and key opinion leaders.
- Support external interactions and business development opportunities; perform due diligence for alliances/in-licensing.
- Serve as clinical contact for alliance projects; assign and manage clinical science staff.
- Lead/coordinate global cross-functional and internal teams; prioritize therapeutic area projects.
- Hire, manage, mentor, motivate, and retain staff; conduct performance reviews and development planning.
Qualifications / Required Skills
- MD or MD/PhD or internationally recognized equivalent with 10+ years pharmaceutical research experience; 7+ years phases I-IV clinical development.
- Highly preferred: Hematology and/or Medical Oncology experience, especially hematologic malignancies.
- Prefer: Successfully leading clinical development or matrix teams across multiple regions (development beyond US/EU a plus).
- Strongly preferred: NDA/MAA/submission experience.
- Preferred: Ability to lead/manage highly trained medical/scientific/technical professionals.
- Required: Superior communication, strategic, interpersonal, and negotiating skills; proactive issue prediction/problem solving; decision-making in multi-disciplinary, multi-regional matrix teams; diplomacy and positive influence across multinational cultures.
Travel
- ~10% travel; willingness to travel to meetings/client sites, including overnight trips; some international travel may be required.
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