Clinical Trial Science Liaison (CTSL)

Summary
The Clinical Trial Science Liaison (CTSL)is a field-based scientific expert within Clinical Development who serves as a value-added extension of the study team by engaging in compliant, peer-to-peer scientific dialogue with Principal Investigators (PIs), Sub-Investigators (Sub-Is), and research physicians. The CTSL strengthens protocol understanding and execution, identifies and helps resolve scientifically rooted implementation challenges, and gathers structured investigator insights to improve trial feasibility assumptions, study delivery quality, and future protocol design. The CTSL may also help to support recruitment activities for the PI (e.g., by engaging a referral network or patient advocacy groups) We will need to ensure that they have the right written materials for this—brochure, poster, slide decks, etc.
This role functions as a scientific liaison between clinical research sites and internal study teams (including appropriate operational partners) to enable consistent study conduct and high-quality external scientific engagement. The CTSL operates within study governance (non-promotional; blinding/data access controls; GCP/ICH and company SOPs) and maintains complete, timely documentation of field interactions and insights in required systems.
Role scope
• Individual contributor supporting assigned program(s)/assets/indications (“book of work”)
• Key contributor to the implementation of Global Clinical Development Strategy for assigned assets/indications
• Ensures consistency of scientific messaging and protocol execution principles across studies within scope
• Field-based with significant external stakeholder engagement; travel required as appropriate for territory/site needs
Key Responsibilities
1) Scientific Investigator Engagement (PI/Sub-I Focus)
• Develop and maintain credible, compliant relationships with PIs/Sub-Is and key study physicians via high-quality scientific exchange related to assigned clinical studies.
• Provide protocol scientific support using approved materials and within governance:
o study rationale and objectives
o endpoint rationale, assessments, and operationalization (feasibility)
o eligibility intent and clinically meaningful enrollment considerations
o procedures, timing windows, and implementation “watch-outs” that impact data quality
2) Protocol Implementation Support (Scientific Quality / Critical-to-Quality)
• Reinforce scientific understanding of critical-to-quality protocol elements (endpoint assessments, timing windows, safety assessments, key procedures).
• Identify recurring points of confusion driving variability (e.g., screening failures, inclusion/exclusion criteria, endpoint inconsistencies) and communicate themes to internal teams to support targeted training, Q&A, or clarification materials.
• When scientifically appropriate and within role boundaries, help troubleshoot site-level scientific implementation barriers and coordinate follow-up to the appropriate internal owner(s).
3) Trial Feasibility, Enrollment & Retention Science (Clinically Grounded)
• Provide scientifically grounded feasibility and enrollment input through investigator discussions on:
o patient flow and referral patterns (e.g., other sites & practices)
o advocacy and community groups
o competing trials and standard-of-care shifts
o barriers to enrollment/retention and mitigation ideas aligned to country/study plans
• Partner with study/country operational leads (e.g., CTM/CRA) to inform recruitment and retention approaches while maintaining role boundaries (CTSL supports scientific execution readiness; operations own delivery execution).
4) Clinical Insights & Feedback Loop to Development team
• Capture and synthesize structured investigator insights on:
o protocol burden/feasibility from a physician perspective
o endpoint relevance and operationalization challenges
o emerging practice patterns affecting inclusion/exclusion and background therapy
• Communicate insights in an action-oriented format that supports decision-making:
o clarification needs and key risk themes
o train and targeted re-training opportunities
o future protocol design improvements
o amendment considerations (as appropriate)
5) Study Team Support, Presentations & Scientific Meetings
• Support scientific components of investigator meetings and site engagement forums:
o content input, scientific Q&A preparation, and key message alignment
o delivery of formal scientific presentations when needed and within governance expectations (e.g., protocol deep-dives, endpoint/assessment rationale)
• As appropriate, attend relevant scientific/clinical meetings or congresses to maintain scientific currency, understand evolving clinical trends, and support relationships with key investigators (within role remit and compliance).
6) Compliance, Quality & Documentation Discipline
• Operate under applicable ICH/GCP and company SOPs; ensure scientific exchanges remain appropriate to role (non-promotional; study-governed; respects blinding and data access rules).
• Maintain complete, timely documentation of external interactions, insights, and follow-ups in required systems; track activity and outcomes per team expectations (including metrics/reporting where applicable).
• Escalate scientific risks, trends, or protocol execution signals appropriately to support inspection readiness and study quality.
• Report any adverse event information, product complaints, or safety concerns encountered in the field via established processes and within required timelines.
Key Stakeholders / Contacts
External
• PIs, Sub-Is, study physicians, study coordinators (scientific interface)
• Site decision-makers and research leadership (as appropriate to study needs)
• Advocacy and Community groups
Internal
• Clinical Science/Clinical Development leadership and study teams
• Country/study operational leads (e.g., CTM/CRA) for aligned execution support
• Regulatory, Quality, and Drug Safety partners as relevant to governance and issue escalation
Qualifications & Experience
Education / Training
• Advanced scientific/clinical degree preferred (e.g., MD, PharmD, PhD, NP/PA) or equivalent combination of education and relevant clinical research experience (therapeutic-area dependent; Neuroscience/Psychiatry experience required based on assignment).
Experience
• Demonstrated experience in a clinical research/development environment with strong understanding of clinical trial methodology and GCP expectations.
• Proven ability to engage physicians in scientific dialogue and translate complex protocol/science into practical execution guidance.
• Strong presentation capabilities (small and large group scientific communications).
• Working familiarity with clinical research/site operations and cross-functional matrix partnering.
Core Competencies
• Scientific agility and credibility; clear translation of data and protocol intent
• Clinical trial literacy (endpoints, Inclusion/Exclusion criteria, assessments, methodology, ethics/regulations)
• Stakeholder management and influence without authority
• Analytical pattern recognition from field insights; pragmatic solutioning
• Excellent oral/written communication; adaptable to investigator/site needs
• Strong organization, documentation discipline, and prioritization across a field territory
Tools / Systems
• Comfort with common clinical systems/tools aligned to trial conduct (e.g., CTMS/eTMF/eDC exposure as applicable) and standard productivity tools.
Field-Based Requirements
• Ability to manage an assigned geography/territory from a home-based office; willingness to travel to investigator sites as required.
• Valid driver’s license (if required for territory travel).