Global Medical Affairs Research Grant & Study Manager

Santen

About The Position

Santen is seeking an experienced Global Medical Affairs Research Grant & Study Manager to join their Global Medical Affairs team. This role is a unique opportunity for a Medical Affairs or Clinical Research professional with deep expertise in Investigator-Sponsored Studies (ISS/IST) and research grants to play a pivotal role in shaping Santen's global evidence-generation strategy. The successful candidate will take direct ownership of investigator-led research programs and serve as a key partner to Medical Affairs, Clinical Development, Compliance, Legal, and external research stakeholders. The role focuses on generating high-quality evidence through investigator-led studies, Phase IV research, registries, observational studies, and real-world evidence initiatives while ensuring robust governance, compliance, and operational excellence.

Requirements

5+ years of experience in Medical Affairs, Clinical Research, Clinical Operations, Evidence Generation, or a related field.
Strong experience managing Investigator-Sponsored Studies (ISS/IST) and research grant programs.
Proven expertise in research grant governance, including review processes, contracting, milestone management, reporting, and payment oversight.
Demonstrated experience in Medical Affairs evidence generation, including Phase IV studies, registries, observational research, and real-world evidence programs.
Experience collaborating with Clinical Development teams and supporting the transition from Phase III clinical programs to post-approval research.
Experience working with investigators, academic institutions, KOLs, CROs, and external research partners.
Bachelor's degree in Life Sciences, Pharmacy, Nursing, Public Health, or another relevant scientific discipline.
Strong working knowledge of GCP, ICH guidelines, and clinical research regulations.
Fluent English communication skills.

Nice To Haves

Advanced scientific degree (PhD, PharmD, MPH, MSc) preferred.

Responsibilities

Lead Global ISS and Research Grant Programs: Own and manage the end-to-end lifecycle of Investigator-Sponsored Studies (ISS/IST) and research grant programs. Coordinate proposal intake, scientific review, governance processes, contracting, milestone tracking, reporting requirements, and payments. Ensure studies are executed in compliance with company policies, ethical standards, and applicable regulations. Maintain inspection-ready documentation and provide oversight throughout study execution.
Drive Medical Affairs Evidence Generation: Lead operational support for Medical Affairs-sponsored evidence generation activities across multiple regions. Manage Phase IV studies, observational research, registries, post-authorization studies, and real-world evidence (RWE) initiatives. Monitor timelines, budgets, deliverables, risks, and study performance to ensure successful execution. Support dissemination of study outcomes through publications, presentations, and scientific communications.
Bridge Clinical Development and Medical Affairs: Partner closely with Clinical Development and Clinical Operations teams to support Phase III programs and facilitate seamless transition into post-approval research. Contribute to evidence-generation planning, investigator engagement, and study feasibility activities. Ensure alignment between development-stage research and Medical Affairs evidence-generation objectives.
Build Strong External Partnerships: Act as a trusted partner to investigators, academic institutions, healthcare professionals, research organizations, and key opinion leaders. Support collaborative research initiatives that advance scientific knowledge and improve patient outcomes. Work with CROs and external vendors to ensure quality delivery and operational excellence.