Job Description

Senior Manager / Associate Director, Clinical Supply Chain

Department: CMC

Position Summary:

TCG Labs-Soleil is looking for a Senior Manager/Associate Director, Clinical Supply Chain who will report to the VP of CMC. This individual will oversee the planning, coordination, and execution of clinical trial material (CTM) supply strategies across multiple development programs and global clinical trials, ensuring that investigational products (IP) and ancillary supplies are delivered on time, sufficient and in compliance with GxP requirements. The ideal candidate is a proactive and detail-oriented professional with a proven track record in clinical supply chain management for biologics, excellent vendor relationship skills, and the ability to thrive in a fast-paced, dynamic environment supporting novel therapeutic development.

Responsibilities:

• Develop and execute comprehensive clinical supply chain strategies for assigned drug development programs from candidate nomination through global clinical trials for early phase development
• Forecast supply needs and manage inventory levels of IPs and clinical supplies
• Lead vendor qualification, evaluation, and selection processes for external vendors and service providers
• Negotiate contracts, service agreements, and purchase orders with external vendors and service providers
• Collaborate with Clinical operations, CMC, Regulatory, QA and external vendors (CMOs, CROs, clinical depots, IRT providers)
• Manage labeling and packaging of bulk drug product and work with QA to release the finished drug product
• Manage distribution and return/reconciliation of CTM
• Coordinate demand planning and manage Interactive Response Technology (IRT) systems for supply strategies.
• Monitor supply chain KPIs (e.g., on-time delivery, inventory turns, waste reduction).
• Ensure compliance with GxP, GDP, and country-specific regulatory requirements.
• Lead or support audits, inspections, and CAPAs related to clinical supplies.
• Maintain accurate documentation, SOPs, and supply chain records.
• Coordinate with CMC, Research, and Clinical teams to understand material requirements and timing needs
• Oversee logistics and inventory management for clinical trial materials, ensuring proper storage, distribution, and chain of custody
• Identify potential supply chain risks and develop contingency plans and mitigation strategies
• Implement risk mitigation strategies for supply chain disruptions and alternative sourcing scenarios
• Support budget planning and cost optimization initiatives

Qualifications:

Required Qualifications

• Bachelor's degree in Supply Chain Management, Operations, Business Administration, Life Sciences, or related field
• 6+ years of experience in clinical supply chain management or clinical trial operations, preferably in biotech/pharmaceutical industry
• Strong understanding of GxP requirements, quality systems, and international clinical supply regulations
• Proven track record of vendor management, contract negotiation, and supplier relationship building
• Knowledge of cold chain logistics and temperature-controlled shipping requirements
• Proficiency in supply forecasting tools, IRT systems, and Microsoft Office suite
• Strong analytical skills with ability to develop forecasts and perform cost analysis
• Excellent communication and negotiation skills
• Ability to work in a fast-paced environment with changing priorities and tight timelines

Preferred Qualifications

• Advanced degree (MBA, MS) in relevant discipline
• Professional certifications (APICS, CSCMP, or similar supply chain credentials)
• Prior use of clinical supply planning software
• Knowledge of international shipping, customs, and import/export regulations
• Ability to manage multiple projects in a fast-paced biotech or pharmaceutical environment.
• Familiarity with oncology or specialty pharmaceutical supply chains
• Experience working in early-stage biotech or venture-backed companies

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 $150,000 - $200,000 annually (both roles are 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 doesnt 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.

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