Director, Toxicology

Director, Toxicology
April 2025

Department: Technology
Work Location: Corporate Headquarters (South San Francisco)

Position Summary:
TCG Labs-Soleil is seeking an experienced Toxicologist with experience in large molecule drug development and a track record of successful regulatory filings. The ideal candidate will lead the nonclinical safety evaluation of biologic drug candidates, from discovery through early clinical development. This role will play a critical leadership function in development project teams. The successful candidate will serve as a key partner across R&D functions, ensuring scientific excellence and driving cross-functional collaboration to understand safety of TCG Labs-Soleil assets prior to first-in-human (FIH) trials.

Responsibilities:

• Provide strategic toxicological assessments and preclinical guidance to cross-functional project teams to inform key program decisions and clinical/regulatory strategies
• Lead project teams from development candidate to FIH.
• Work closely with Pharmacology, DMPK, Clinical, Regulatory Affairs, and CMC teams to integrate nonclinical data into development plans.
• Foster a culture of scientific excellence, innovation, and compliance.
• Design, execute, and interpret nonclinical safety studies (GLP and non-GLP).
• Author and review regulatory submissions including INDs, CTAs, IBs, and briefing documents.
• Interact with global regulatory agencies, including responding to queries and participating in meetings.
• Participate in due diligence and portfolio evaluation of biologic assets.
• Collaborate closely with external CROs to ensure high-quality, on-time delivery of study reports.

Qualifications:

• PhD in Toxicology, Pharmacology, or a related discipline. DABT certification highly desirable.
• 10+ years of experience in nonclinical safety assessment with expertise in large molecule therapeutics.
• Strong understanding of pharmacology, toxicokinetics, immunogenicity, and species relevance for toxicology evaluation related to large molecule therapies.
• Demonstrated track record in designing and leading GLP toxicology programs and preparing regulatory submissions.
• Experience interacting with global health authorities (e.g., FDA, EMA).
• Strong scientific background and scientific aptitude with excellent critical thinking skills, decisiveness, and goal-oriented approach will be key to meeting timelines while upholding scientific excellence.
• Ability to work effectively and collaboratively on cross-functional project teams; demonstrated ability to multi-task, prioritize options, anticipate challenges, and execute goals as a member of an interdisciplinary team is extremely important.
• Excellent verbal and written communication skills.

Company Overview

TCG Labs-Soleil, established in partnership with The Column Group, a science-focused venture capital firm, 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.

For more details, visit TCGLSoleil.com and follow us on LinkedIn

EEO Statement

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.

Benefits and Compensation

TCG Labs-Soleil provides a competitive benefits package that includes access to Medical, Dental, and Vision Insurance, Life Insurance, Short and Long Term Disability, Health Savings Account (HSA), Flexible Spending Accounts (FSA), 401k plan and PTO.

The anticipated salary range for fully qualified candidates applying for this role will be $168,000 - $300,000 annually (not including discretionary bonus, equity, and benefits). The final salary offered will be dependent on several factors that include but are not limited to relevant previous experience including duration and type of experience within the industry, education, and internal equity.

Staffing Agencies

TCG Labs-Soleil does not accept unsolicited agency resumes and will not pay fees to any third-party agency or firm that doesn't have a signed agreement with TCG Labs-Soleil. Please do not send agency CVs/resumes through TCG Labs-Soleil website or TCG Labs-Soleil Employees. Inquiries must be sent to contact@tcglsoleil.com with the Subject Heading: Staffing Agency Request.