Director/Senior Director, Clinical Operations 

 

Department: Clinical Operations

Work Location:  Corporate Headquarters (South San Francisco)

Position Summary:

TCG Labs-Soleil is looking for a Director/Sr. Director, Clinical Operations. This individual will lead the planning, execution, and oversight of all clinical trial activities across the company’s development programs. This individual will provide strategic and operational leadership to ensure high-quality, compliant, and efficient conduct of clinical studies in alignment with corporate goals and regulatory requirements. The ideal candidate thrives in a fast-paced, entrepreneurial environment and brings hands-on experience managing global clinical operations in early- and/or late-stage biotech settings.

 

Key Responsibilities

  • Lead the development and execution of clinical operational strategies and plans across all programs.
  • Oversee day-to-day operations of clinical studies, including vendor selection and management, site initiation, monitoring, data collection, and study closeout.
  • Partner cross-functionally with Clinical Development, Regulatory Affairs, Biometrics, Quality, and CMC teams to ensure seamless program execution.
  • Manage timelines, budgets, and resources to ensure programs meet corporate and regulatory milestones.
  • Develop and maintain standard operating procedures (SOPs), templates, and best practices for clinical operations.
  • Provide leadership, mentoring, and professional development for internal Clinical Operations staff and external contractors.
  • Drive operational excellence, risk management, and continuous improvement across clinical programs.
  • Ensure compliance with GCP, ICH guidelines, FDA regulations, and other global regulatory standards.
  • Represent Clinical Operations in internal governance committees, CRO oversight meetings, and external partner interactions.
  • Support due diligence, audit readiness, and inspection preparedness activities.

Qualifications

  • Bachelor’s degree in life sciences or related field required; advanced degree (MS, PhD, PharmD) preferred.
  • 10+ years of experience in clinical operations within the biopharmaceutical industry, with at least 5 years in a leadership role.
  • Proven track record managing complex, multi-center global clinical trials (Phase I–III).
  • Experience working in a small biotech or startup environment strongly preferred.
  • Strong understanding of GCP, ICH, and FDA/EMA regulations.
  • Excellent organizational, leadership, and communication skills.
  • Ability to thrive in a dynamic, resource-constrained, and highly collaborative environment.
  • Demonstrated experience managing CROs, vendors, and budgets effectively.
  • Strategic thinker with hands-on operational capabilities.

 

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 is $200,000 - $270,000 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.