Manager (Study Design Lead)

The Asian Thoracic Oncology Research Group

( ATORG ) is the coordinating platform

for translational research in Asia. Its mission is to advance

medical knowledge of lung cancer and improve health outcomes of

patients through clinical studies and scientific events. ATORG

operates under National Cancer Centre

Singapore.

The Asia Pacific Oncology Drug

Development Consortium ( APODDC ) was

formed in 2020 as a platform to foster education and collaboration

between key stakeholders of oncology drug development within the

Asia Pacific region, thereby improving treatment access to

patients. APODDC drives regional activities in collaboration with

institutions in the region and industry

partners.

This Study Design

Lead role will lead the scientific and operational

design of ATORG and APODDC's multi-country oncology research

programs, 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.

Main

Responsibilities : 1. 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

2.

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

3. 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.

4. 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.

5.

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.

6. 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.