Clinical Research Scientist (MD)

Position Summary: 

TCG Labs-Soleil is seeking a highly skilled Clinical Research Scientist (MD) to provide medical and scientific leadership across the design, execution, and interpretation of clinical trials within an assigned program. Working in close partnership with Clinical Operations, Biostatistics, Regulatory Affairs, and Translational Sciences, this individual will serve as a primary medical resource for study conduct, data interpretation, and benefit-risk assessment. The role contributes to clinical development plans, protocol authoring, regulatory submissions, and external engagement with investigators, key opinion leaders, and health authorities.

Responsibilities: 

Clinical Development Strategy

• Contribute medical and scientific input to clinical development plans, target product profiles, and program-level strategy.

• Translate preclinical and translational data into testable clinical hypotheses, endpoints, and patient-selection strategies.

Protocol Design and Study Execution

• Author and maintain protocols, amendments, informed consent templates, and study-specific medical monitoring plans.

• Serve as medical monitor for assigned studies, including eligibility adjudication, protocol deviation review, and real-time clinical query resolution.

• Provide medical training to investigators, site staff, CRO partners, and internal study teams.

• Partner with Clinical Operations on feasibility, site selection, enrollment strategy, and risk-based monitoring.

Data Review and Interpretation

• Lead ongoing medical review of clinical, laboratory, imaging, and biomarker data to ensure quality, consistency, and patient safety.

• Collaborate with Biostatistics on statistical analysis plans, data review meetings, and interpretation of interim and final results.

• Contribute to data monitoring committee and safety review committee materials and participate in associated meetings.

Safety and Benefit-Risk

• Partner with CRO Pharmacovigilance on the assessment of serious adverse events, safety signals, and aggregate safety reporting.

• Contribute to benefit-risk assessments, DSURs, Investigator’s Brochure updates, and risk-management documentation.

Regulatory and Scientific Communication

• Author and review clinical sections of INDs/CTAs, briefing books, and clinical study reports.

• Support health authority interactions, including preparation of responses to regulatory questions.

• Contribute to abstracts, manuscripts, congress presentations, and advisory board content.

• Engage investigators, key opinion leaders, and patient advocacy groups to inform trial design and execution.

Reporting and Travel

• Report to the Head of Clinical Development (Immunology) for the assigned program.

• Travel approximately 15–25% domestically and internationally for investigator meetings, site visits, congresses, and health authority interactions.

Qualifications:

Required Qualifications

• MD or MD/PhD from an accredited institution, with completion of residency training; internal medicine preferred.

• Active or previously active medical license in good standing.

• Working knowledge of ICH-GCP, FDA and EMA regulations, and the drug development lifecycle.

• Demonstrated ability to critically interpret clinical and translational data and communicate conclusions clearly.

• Excellent written and verbal communication skills, including scientific writing.

Preferred Qualifications

• Prior industry experience as a clinical research scientist, medical monitor, or medical director in biotech, pharmaceutical, or CRO settings.

• Experience contributing to regulatory submissions and health authority interactions.

• Familiarity with biomarker strategy and translational medicine.

• Publication record in peer-reviewed journals.

Core Competencies

• Scientific rigor and sound clinical judgment under conditions of incomplete data.

• Cross-functional collaboration and the ability to influence without direct authority.

• Organizational agility and comfort managing competing priorities across multiple studies.

• Commitment to patient safety, data integrity, and ethical research conduct.