Lead Oncology Study Design Specialist

This is a key leadership role that will be responsible for leading the scientific and operational design of multi-country oncology research programs. The successful candidate will ensure that all studies are scientifically rigorous, operationally feasible, and aligned with the mission to deliver high-impact evidence that advances cancer care in the Asia-Pacific region.

• Scientific Communication & Publication (30%):
  • Develop study concepts, designs, and protocols for multi-country IITs and translational studies.
  • Collaborate with PIs, scientific committees, and industry partners to define objectives, endpoints, and biomarker strategies.
  • Ensure designs integrate translational science, statistical methodology, and regulatory requirements.
  • Lead manuscripts and abstract development as well as coordinate conference presentation for ESMO Asia and WCLC.
• Protocol & Feasibility Development (25%):
  • Draft and refine study protocols, synopses, schema, and feasibility questionnaires.
  • Conduct feasibility assessments with participating sites, considering country-specific operational challenges.
  • Integrate site capabilities, recruitment targets, and vendor requirements into study plans.
• Stakeholder Engagement (15%):
  • Serve as liaison between ATORG/APODDC leadership, site investigators, CROs, and vendors.
  • Facilitate consensus meetings, advisory boards, and protocol review committees.
  • 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 ICH-GCP and consortium SOPs.
  • Ensure protocols and trial documents are audit-ready before finalisation.
• 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.
  • Ensure compliance with ICH-GCP, local regulations, and consortium SOPs.
• Manage other tasks (5%):
  • Contribute to grant applications, scientific publications, and conference presentations.
  • Support training and mentoring of junior team members in study design and protocol development.
  • Undertake other responsibilities as assigned by the PI.

• Masters OR PhD in Life Sciences, Pharmacy, Public Health, or related field; MBBS/MD preferred.
• Formal training or certification in clinical research, medical writing, or biostatistics will be an advantage.
• Minimum 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.
• Experience integrating QA/quality-by-design principles into clinical study planning.
• Demonstrated success in developing and publishing peer-reviewed manuscripts and abstracts for scientific meetings.
• Prior experience working with multi-stakeholder research consortia, academic institutions, or industry collaborators in the Asia-Pacific region.

The ideal candidate will have excellent analytical and problem-solving skills, with the ability to evaluate scientific feasibility, identify risks, and propose practical solutions. They should also possess strong communication and stakeholder engagement skills, with the ability to manage relationships with investigators, sponsors, vendors, and internal teams across different cultures and geographies.

The role requires technical proficiency with MS Office, reference management software, and clinical trial management systems (CTMS). A background in life sciences, pharmacy, public health, or a related field is essential, with formal training or certification in clinical research, medical writing, or biostatistics being an advantage.