Research Oncology Study Designer

We are seeking an experienced Study Design Lead to lead the scientific and operational design of our multi-country oncology research programs. This role will ensure that all studies are scientifically rigorous, operationally feasible, and aligned with our mission to deliver high-impact evidence that advances cancer care in the Asia-Pacific region.

The successful candidate will be responsible for leading the development of study concepts, designs, and protocols for multi-country investigator-initiated trials and translational studies. They will collaborate with principal investigators, scientific committees, and industry partners to define objectives, endpoints, and biomarker strategies.

The ideal candidate will have a strong understanding of translational science, statistical methodology, and regulatory requirements. They will also have excellent communication and problem-solving skills, with the ability to translate complex scientific data into clear and accurate protocols, manuscripts, and presentations.

• Scientific Communication & Publication (30%): Develop study concepts, designs, and protocols for multi-country IITs and translational studies, and lead manuscripts and abstract development as well as coordinate conference presentation for scientific meetings.
• Protocol & Feasibility Development (25%): Draft and refine study protocols, synopses, schema, and feasibility questionnaires, conduct feasibility assessments with participating sites, and integrate site capabilities, recruitment targets, and vendor requirements into study plans.
• Stakeholder Engagement (15%): Serve as liaison between leadership, site investigators, CROs, and vendors, facilitate consensus meetings, advisory boards, and protocol review committees, and engage with pharma, biotech, and funding bodies for study collaboration.
• Quality Assurance (QA) Integration (15%): Embed quality-by-design principles into protocol and operational workflows, review study-specific operational, safety monitoring, and data management plans for compliance with international and local regulations, SOPs, and ethical standards.
• Operational & Quality Oversight (10%): Collaborate with Clinical Operations to ensure designs are executable within timelines and budgets, support the development of safety monitoring, QA frameworks, and data management plans, and ensure compliance with international and local regulations, SOPs, and ethical standards.

The ideal candidate will have:

• A Master's or PhD in Life Sciences, Pharmacy, Public Health, or related field, with formal training or certification in clinical research, medical writing, or biostatistics being an advantage.
• A minimum of 7 years' experience in clinical research, with at least 3 years in study design, medical affairs, or scientific writing/publication roles.
• Proven track record in designing and implementing multi-country investigator-initiated trials or equivalent academic-led research, integrating QA/quality-by-design principles into clinical study planning, developing and publishing peer-reviewed manuscripts and abstracts for scientific meetings, and working with multi-stakeholder research consortia, academic institutions, or industry collaborators in the Asia-Pacific region.

This role offers:

• Opportunities to work on cutting-edge research projects and collaborations in the Asia-Pacific region.
• Chance to develop and implement innovative study designs and protocols.
• Collaboration with international teams and stakeholders.
• Professional growth and development opportunities.

Please note that this job description is subject to change based on business needs and available resources.

The successful candidate will be required to undergo background checks and may need to travel for business purposes.