Early Development Strategy Lead (APAC)

To serve as the regional subject matter expert in Early Development (Phase I / First-in-Human / Proof-of-Concept / Basket trials) for the APAC region, providing deep scientific and operational intelligence to inform global and regional trial design and execution strategies. A focus of the position will be Oncology.

Where appropriate, to optimise relationships with CRO partners and country level clinical sites, all whilst ensuring accelerated and high-quality execution of Ipsen-sponsored Early Development clinical trials

Accountable for delivery of Global and Regional (APAC ) Early Development clinical trials to facilitate successful regulatory submissions by ensuring data integrity, inspection readiness and to maintain alignment with global development strategy.

To optimize the country contribution to early clinical programs, Global and Regional, through proactive operational leadership, KOL engagement, and effective cross-functional collaboration.

To act as the strategic bridge between Global Early Development teams and the APAC site/investigator landscape, ensuring that protocol design, feasibility, and site selection are informed by the most current, on-the-ground intelligence and relationships with Phase I units across the region.

To build the APAC Region Early Development operations skills through effective recruitment and staff development and through a mindset of continuous improvement and innovation. Optimise the FSP organizational structure in support of Early Development strategy and clinical studies across APAC.

Main Responsibilities & Technical Competencies Early Development Site Network Relationship Management

• Develop a regional network of preferred sites in Early Development and optimize the relationships with these sites to ensure that IPSEN is seen as a partner of choice in Early Development
• Support dissemination of approved clinical trial–related information to investigators (in coordination with Medical Affairs in the APAC region)
• Be the Primary IPSEN Early Development contact for Country and Regional KOLs across APAC
• Develop and execute KOL engagement strategies to support clinical trial success and strengthen the APAC regions positioning within global Early development programs.

Strategic Design and Study Input

• Be the Regional CDO Early Development representative within Global Study Teams, ensuring alignment between global clinical strategy and local operational execution
• To be the APAC region expert in Clinical Operations with a focus on Early Development and to provide proactive strategic input to Global Operations regarding country specific regulatory, operational, enrollment, and Key Opinion Leader/Investigator landscape considerations.
• Provide structured feedback from investigators and KOLs to Global teams, including insights on unmet needs, protocol feasibility, competitive intelligence.
• Ensure intelligence is shared with Global Teams so that study start up, conduct and close out are informed by local country requirements and local barriers to delivery are mitigated
• Collect and analyze all data to inform protocol development and operational plans related to pipeline delivery
• Leads country/regional level escalation for operational risks impacting study timelines or regulatory milestones for local and global studies
• Accountable to design and implement country/region specific acceleration strategies to shorten study start-up timelines and enhance patient enrollment while maintaining global standards and inspection readiness
• Optimise feasibility assessment across APAC, site selection, contract execution, and IRB approval timelines in collaboration with CRO and internal stakeholders.

Capability Building

• Develops expertise (self and in colleagues) in disease state management, emerging therapies, and the competitive landscape to optimize the country contribution to IPSEN Clinical Studies. A focus will be the Oncology TA
• Mentors and supports the CRAs (FSP or Full service CRO) that are working on ED studies in APAC
• Support upskilling of regional CRA teams (FSP or CRO-partnered) on early-development specific requirements, including basket trial conduct, patient identification strategies, and Phase I unit dynamics
• Where necessary, oversees CRO performance to ensure delivery against timelines, budget, and quality standards; establish clear KPIs and drive corrective actions where needed

Regional Representation

• Collaborate closely with country/Regional Medical Affairs to ensure appropriate site level information exchange while maintaining clear functional boundaries.
• Support preparation of clinical and operational components of country regulatory packages in collaboration with Global Clinical and Regulatory teams.
• Partner closely with Global Clinical Development, Regulatory, and other functions to ensure regional intelligence is incorporated into regulatory submissions, IND strategies, and site engagement plans.
• Provide timely support for responses to regulatory queries related to clinical trial conduct and data interpretation
• Represents IPSEN at appropriate national, regional, and international meetings in the relevant therapeutic area, serving to gather information on developments in the therapeutic area, and becomes a country ambassador

Quality and Continuous Improvement

• Ensure protocol compliance, data integrity, and continuous inspection readiness at assigned clinical sites.
• Responsible to drive performance improvement initiatives and a continuous improvement mindset in relation to Early Development studies
• Contribute to inspection preparation activities and ensure all assigned trials remain audit-ready

Knowledge & Experience Knowledge & Experience:

• Minimum 10 years of experience in Clinical Development/Operations within the pharmaceutical industry
• Demonstrated Expertise in Early Development Programmes particularly Oncology
• Demonstrated understanding of early-phase trial design, including basket, umbrella, and adaptive designs in oncology.
• Demonstrated track record in selecting and building relationships with key Early Development Sites across APAC
• Demonstrated CRO oversight and performance management experience.
• Participation in Global Study Teams with demonstrated cross-regional and cross functional collaboration experience.
• Strong knowledge of Local/Global GCP requirements and inspection processes.
• Proven experience in clinical trial start-up and enrollment management for local and Global studies
• Experience supporting NMPA and/or other APAC regional regulatory submissions and query responses preferred.
• Strong project management skills with ability to manage multiple priorities.
• Excellent analytical, communication, and stakeholder management skills
• Excellent communication and influencing skills, with the ability to work effectively across matrix teams without direct line authority over operational staff
• Demonstrated ability to manage change and to implement an environment of continuous improvement and innovation

Education / Certifications

• A minimum of Bachelor of Science, post-graduate degree (or equivalent) in life sciences or related field is desirable.

Language(s) Fluent verbal and written communication skills in local language and English