Job Description
Basic Purpose of the Job
The Strategic Partnership Manager contributes to the Clinical Research Organisation (CRO) strategic partnership by ensuring seamless and efficient interfaces and delivering pipeline commitments with speed and high customer value.
The role provides direction and leadership in Japan while representing the Global Vendor Management Network. It is responsible for CRO strategic partnership engagements in Japan, including quality oversight, performance management, contractual and financial oversight, and continuous enhancement of CRO relationships. The position ensures execution of the global vendor management strategy in Japan aligned with Company Priorities.
The role collaborates closely with the Delivery Model Team in CDO Partnerships (CD&O Regions), the CRO, and other local/global functions to drive clinical development excellence.
Accountabilities
- Implement, oversee, and maintain the strategic CRO partnership and operating model in Japan in alignment with OneHP strategic priorities, Medicine Excellence goals, and CDO priorities.
- Ensure strong collaboration with Global CDO and CRO to drive operational excellence and delivery of pipeline commitments.
- Lead vendor governance processes in Japan. Conduct regular governance meetings focusing on operational delivery, quality, contractual, and financial oversight.
- Assess CRO performance using internal/external benchmarks and KPIs. Provide Japan performance feedback to the Partnership Lead of Delivery Model in CDO Partnerships.
- Manage CRO issue escalation and resolution in Japan to ensure timely delivery of clinical studies.
- Lead and oversee vendor staff onboarding to ensure timely access to BI systems.
- Co-develop tools, processes, and instructions to enhance vendor performance and service delivery.
- Support local Quality Management during internal and regulatory audits/inspections.
- Define service scope/specifications required from CRO in Japan with key stakeholders.
- Provide CRO with projected resource requirements and ensure appropriate resourcing for current and future projects.
- Collaborate with Delivery Model Team on FSP work orders, change orders, and contracting. Collaborate with Sourcing for purchasing activities.
- Serve as primary CRO contact in Japan; manage communication on assignments, trial changes, timelines, site numbers, issues, and escalations.
- Oversee CRO staff transitions to ensure sound transition planning.
- Lead training and change management activities related to the CRO operating model.
- Monitor industry trends and communicate insights to the Partnership Lead and management.
- Collaborate on local vendor engagement implementation, ensuring qualification and oversight plans comply with Medicine procedures.
- Support definition of oversight measurements for continuous improvement in Japan.
- Foster a learning culture, promote continuous learning, best practices, and smart risk-taking.
- Serve as subject matter expert in Strategic Partnership Management; coach CDO personnel; potentially lead vendor management teams.
- Maintain ongoing communication with internal stakeholders.
Regulatory / Organisational Requirements
Adhere to national and international regulations and legal rules. Ensure all work complies with BI SOPs, Business Practices, HTGs, and regulatory requirements. Maintain the highest ethical and professional standards with a focus on quality, BI values, speed, and patient value.
Job Complexity
Medium to high complexity due to interdisciplinary interfaces across Japan, Corporate CDO functions, and CRO partners. Requires critical thinking and deep understanding of local regulatory and ethical clinical development requirements.
Interfaces
Internal:
- Partnership Lead of Delivery Model & Vendor Management Network
- Japan & Global Enabling Functions (Finance, Legal, Sourcing)
- CDO Japan personnel (CTM, Head of Local Vendor Management, HCO, enabling functions)
- Quality and Compliance Japan
External:
Job Expertise
- Professional experience in clinical operations; ideally in vendor management (sponsor/vendor side).
- Experience in Therapeutic Areas relevant to BI pipeline preferred.
- Comprehensive knowledge of organizational and corporate strategy.
- Ability to execute strategy and demonstrate “Our Behaviors.”
- Extensive international and cross‑functional experience.
Job Impact
- Steers the CRO operating model aligned with One Medicine vision.
- Enables improved patient and site experience, establishing BI as a preferred clinical trial sponsor.
- Provides leadership and coordination across internal/external stakeholders.
- Contributes to execution of the Strategic CRO partnership in Japan.
- Engages in decision making and risk-taking based on complex information.
- Provides oversight aligned with ICH E6 R3 and acts as a trusted advisor on vendor topics.
Minimum Education / Degree Requirements
- University degree and/or comparable professional experience.
- Major in Life Science or Business.
- Experience in clinical operations in pharmaceutical industry and/or CRO.
- 5+ years clinical research experience, ideally vendor management/outsourcing.
Required Capabilities
- Communication Skills: Strong communication in cross‑functional matrix environments; cultural awareness; alignment of strategy.
- Operational Expertise: Therapeutic knowledge across outsourced work packages.
- Leadership & Influence: Ability to set direction in complex situations, inspire teams, support and empower others.
- Strategic Mindset: Future-focused, innovative, results‑driven, strong analytical thinking.
- Customer Value Driver: Build strong relationships and deliver customer‑focused solutions.
- Coordination & Oversight: Strong prioritization, pacing, and resource management.
- Financial Acumen: Ability to interpret financial indicators for better decision-making.
- Cross-functional Collaboration: Build alliances and coalitions inside and outside the organization.
- Curiosity & Innovation: Desire to learn, explore, and innovate.
- Digital Savviness: Ability to navigate and leverage digital tools effectively.
Required English Level:
CEFR B2
