Associate Director, ISR Strategy & Governance at Boston Scientific Corporation Malaysia
Seoul, , South Korea -
Full Time


Start Date

Immediate

Expiry Date

05 May, 26

Salary

0.0

Posted On

04 Feb, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Clinical Research, Medical Affairs, Governance Frameworks, Data Gaps, Ethical Standards, Regulatory Compliance, Operational Excellence, Cross-Functional Collaboration, Communication Skills, Interpersonal Skills, Scientific Guidance, Investigator Relationships, Real-World Evidence, Study Proposal Assessment, Clinical Development Processes, Strategic Alignment

Industry

Medical Equipment Manufacturing

Description
Research Strategy & Evaluation Lead the strategic evaluation, prioritization, and endorsement of ISR proposals to ensure alignment with APAC and global evidence generation priorities. Shape APAC's ISR scientific roadmap by identifying critical data gaps and unmet clinical needs in collaboration with global, regional, and local medical teams. Provide scientific and methodological guidance to investigators and internal stakeholders to enhance research quality and relevance. Ensure robust adherence to ISR governance frameworks, ensuring all activities comply with ethical standards, local regulatory requirements, and internal corporate policies and governance expectations. Implement solutions and make recommendations to management to improve performance and impact. Act as the strategic liaison, establishing strong collaboration relations with Clinical Affairs and key functions including Medical Affairs, Clinical Operations, Finance, Regulatory, Compliance, and Legal to drive seamless ISR execution, as well as reinforce and align the clinical and commercial messages through scientific affairs Oversee governance processes related to ISR study approval, including representation in APAC and global clinical governance bodies to align portfolio decisions and study prioritization. Ensure compliance with internal decision-making frameworks, SOPs, and industry regulations across all ISR activities. Drive operational excellence through collaboration and influence, ensuring transparency and alignment across stakeholders. Bachelor's degree in Life Sciences, Pharmacy, Medicine, or related field; advanced degree (PhD, PharmD, MD) preferred. Minimum 10 - 12+ years of experience in clinical research, clinical affairs, or medical affairs, with direct involvement in ISR or investigator-initiated trials. Strong understanding of clinical development processes, research governance, and real-world evidence generation. Proven ability to assess study proposals for scientific merit, operational feasibility, and strategic alignment. Experience working with cross-functional teams including legal, compliance, and regulatory functions. Exceptional communication and interpersonal skills, with experience building investigator relationships. Fluent in English; proficiency in other APAC languages is a plus (Korean, Japanese, Mandarin) Willingness to travel within the region (up to 30%).
Responsibilities
Lead the strategic evaluation and endorsement of ISR proposals to align with APAC and global priorities. Oversee governance processes related to ISR study approval and ensure compliance with internal frameworks and regulations.
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