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About the Role

TCG Labs-Soleil is seeking a Clinical Research Scientist (MD) to provide medical and scientific leadership for clinical trials. This role involves contributing to clinical development plans, protocol authoring, regulatory submissions, and engaging with external stakeholders.

Responsibilities

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Requirements

• 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.
• Minimum 4 years of relevant life sciences, clinical development, or industry experience.
• 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.
• 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.
• 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.

Skills

• Clinical trial design
• Clinical trial execution
• Data interpretation
• Benefit-risk assessment
• Protocol authoring
• Regulatory submissions
• Investigator engagement
• Key opinion leader engagement
• Health authority interaction
• Scientific writing
• Biomarker strategy
• Translational medicine

Location

• CORPORATE HEADQUARTERS (SOUTH SAN FRANCISCO)

Work Type

• Full-time

Experience Level

• Minimum 4 years of relevant life sciences, clinical development, or industry experience
• Prior industry experience as a clinical research scientist, medical monitor, or medical director in biotech, pharmaceutical, or CRO settings.

Education Level

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

Salary/Compensations

• $204,000 - $354,000 annually (not including discretionary bonus, equity, and benefits)

Benefits

• Medical, Dental, and Vision Insurance
• Life Insurance
• Short- and Long-Term Disability
• Health Savings Account (HSA)
• Flexible Spending Accounts (FSA)
• 401(k) plan
• Paid time off

About the Company

• TCG Labs-Soleil, established in partnership with The Column Group, is pioneering a novel ‘venture capital-biotech’ model.
• Our core mission is to efficiently translate scientific insights into therapeutic solutions for patients facing serious diseases.
• This model supports scientific entrepreneurs from the initial idea to clinical proof of concept (PoC) by combining a dedicated fund (TCG Labs) with our independent, evergreen R&D center led by a top-tier scientific team (Soleil).
• Together, we create an integrated ecosystem that fosters the development of single-asset portfolio companies, strategically poised for transacting after clinical PoC.

Equal Opportunity

• TCG Labs-Soleil is an Equal Opportunity Employer.
• We do not discriminate against qualified applicants based upon any protected group status, including but not limited to race, religion, color, creed, sex (including breastfeeding and related conditions), gender identity/gender expression, pregnancy (including childbirth and related conditions), national origin, ancestry, age, marital status, military or veteran status, sexual orientation, genetic information, physical or mental disability or medical condition as defined by applicable equal opportunity laws.
• Any request for accommodation can be directed to contact@tcglsoleil.com.