Vice President, Clinical Operations 

 

Department: Clinical Operations

Work Location:  Corporate Headquarters (South San Francisco)

Position Summary:

The Vice President, Clinical Operations is accountable for timely, end to end quality evidence generation in support of Soleil’s clinical corporate goals and objectives, through management and oversight of Clinical Operations.  The VP will report to the Chief Medical Officer and will provide subject matter expertise and guidance to cross-functional teams in a fast-paced high growth environment team to ensure that clinical trials are conducted on time and budget, and in accordance with applicable GCP/ICH guidelines and other regulatory requirements.   This is an on-site/hybrid role based in South San Francisco.

 

Primary Responsibilities

  • Accountable for maintaining oversight of clinical programs to ensure timely and high-quality study execution, data generation and analysis to support regulatory filings.
  • Accountable for delivering on clinical operations scenario planning, high level forecasting of timelines, assessment of program level feasibility.
  • Accountable for ensuring resource availability to maintain inspection-readiness across clinical programs.
  • Accountable for preparing and presenting trial parameters and clinical information to executive leadership, vendors, and other key stakeholders.
  • Responsible for identification, prioritization, and definition of new processes and systems to support organizational growth.
  • Responsible for developing hiring and retention strategies to ensure appropriate resourcing across Clinical Operations.
  • Responsible for providing input, as needed, for clinical and regulatory documents.

Qualifications

  • Bachelor’s degree required, higher degrees in life sciences preferred
  • At least 15 years of experience working with clinical research organization to manage global clinical trials.  Rare disease experience is a plus. 
  • At least 10 years experience managing direct report, evidencing strong leadership, team-building, and hands on management.
  • Demonstrated ability to build high-functioning teams that can adapt to changing priorities.
  • Demonstrated knowledge of the drug development process in the bio/pharmaceutical industry with an understanding of relevant regulatory requirements.
  • Comprehensive understanding of ICH and GCP guidelines, as well as applicable regulations and practices. 
  • Excellent organizational skills and attention to detail. 
  • Effective communication and interpersonal skills. 
  • Able to set priorities and juggle multiple demands.
  • Able to think critically, diagnose root causes and be a proactive problem-solver.
  • Able to work independently while exercising initiative, flexibility and sound judgment.
  • Comfortable working with different levels of the company including senior level management.

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 $300,000 - $360,000 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.