Director, Nonclinical Operations

Director, Nonclinical Operations
April 2025

Department: Translational Research
Work Location: Corporate Headquarters (South San Francisco)

Position Summary:

TCG Labs-Soleil is looking for a strategic and experienced nonclinical operations professional to join the Nonclinical Development team. As the primary point of contact for outsourced nonclinical studies, the role is critical to the planning, execution, and management that is in alignment with regulatory and company objectives. The successful candidate will serve as a key partner across R&D functions, ensuring operational excellence and driving cross-functional collaboration to support the progression of TCG Labs-Soleil assets from discovery through early clinical development

Responsibilities:

• This individual will be responsible for planning, managing, executing, and coordinating the finalization of nonclinical studies (GLP and nonGLP pharmacology, toxicology, and DMPK studies), including study start-up, execution, and close-out activities, timelines, and deliverables.
• Study Monitoring: sample tracking, shipment, and reconciliation to ensure accuracy and timely delivery. May include on site study monitoring, data processing to generate tables, figures, and listings to support nonclinical study reports and regulatory submissions.
• Identify, evaluate, and manage relationships with Contract Research Organizations (CROs) and other external vendors. Negotiate budgets, contracts, and timelines for nonclinical studies. Support contracts and purchasing process for nondisclosure agreements (NDA), master service agreements (MSA), statements of work (SOW), purchase orders (PO), and invoicing.
• Participate in study design or project team discussions as needed to support team deliverables and goals. Serve as the operational liaison between research, toxicology, and other internal teams such as quality assurance, regulatory affairs, and project management.
• Ensure adherence to GLP (Good Laboratory Practices), GCP (Good Clinical Practices), and other relevant regulatory guidelines.
• Support preparation for regulatory inspections and audits, including maintaining study records and documentation.

Qualifications:

• Graduate degree in life sciences, or a related field.
• 10+ years industry experience, including of 5+ years of experience in nonclinical safety operations.
• Strong knowledge of GLP and regulatory requirements for nonclinical studies.
• Experience with vendor management, budget oversight, and contract negotiations.
• Proven ability to manage multiple projects, timelines, and deliverables.
• Excellent communication, organizational, and problem-solving skills.
• Proficiency in project management tools and software.
• Proactive and detail-oriented with the ability to anticipate and resolve issues.
• Strong interpersonal skills and the ability to build effective relationships across teams.
• Adaptability to change priorities and project needs in a fast-paced environment.

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.