Senior Study Design Expert

The Study Design Lead will play a key role in the scientific and operational design of multi-country oncology research programs. This includes ensuring that all studies are scientifically rigorous, operationally feasible, and aligned with the consortium's mission to deliver high-impact evidence that advances cancer care in the Asia-Pacific region.

• Scientific Communication & Publication (30%):
  • Lead development of 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.
  Key Requirements:
  • Master's 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.
  Advantageous Skills to Have:
  • Scientific Writing & Communication: Excellent ability to translate complex scientific and clinical data into clear, accurate protocols, manuscripts, and presentations.
  • Analytical & Problem-Solving: Strong capability to evaluate scientific feasibility, identify risks, and propose practical solutions.
  • Stakeholder Engagement: Skilled in managing relationships with investigators, sponsors, vendors, and internal teams across different cultures and geographies.
  • Organisational & Project Management: Ability to manage multiple projects concurrently, meet deadlines, and maintain attention to detail.
  • Regulatory & Compliance Awareness: Competence in ensuring study design, documentation, and publications comply with international and local regulations, SOPs, and ethical standards.
  • Technical proficiency with MS Office, reference management software, and clinical trial management systems (CTMS) is desirable.