Associate Director, Clinical Supply

$180,000 - $210,000/Yr

Tempest Therapeutics - South San Francisco, CA

Full-time - Senior

South San Francisco, CA

Chemical Manufacturing

About the position

The Associate Director of Clinical Supply plays a critical role in ensuring the timely and efficient delivery of clinical supplies for our clinical trial programs. This individual will be responsible for overseeing clinical supply chain activities, from forecasting and planning to packaging, labeling, and distribution. This position will collaborate closely with various internal and external stakeholders to ensure that clinical supplies meet regulatory requirements and are available at the right time and place to support trial execution.

Responsibilities

• Develop and execute clinical supply strategies for oncology clinical trials, ensuring alignment with trial protocols, regulatory requirements, and company objectives.
• Collaborate with cross-functional teams to develop supply forecasts, inventory plans, and distribution strategies.
• Oversee the selection and management of clinical supply vendors and partners to include IRT and potentially fulfill role on unblinded sponsor representative where necessary.
• Manage clinical supply chain activities, including packaging, labeling, distribution, and returns.
• Ensure compliance with Good Manufacturing Practices (GMP) and Good Clinical Practice (GCP) guidelines.
• Develop and maintain clinical supply chain documentation, including SOPs, work instructions, and batch records.
• Oversee relationships with clinical supply vendors, including contract development manufacturing organizations (CDMOs), packaging providers, logistics partners and co-therapy/ancillary sourcing vendors.
• Identify and monitor KPIs related to vendor performance and ensure compliance with quality standards and project timelines.
• Identify and implement opportunities for continuous improvement in clinical supply chain processes.
• Stay abreast of industry trends and best practices in clinical supply chain management including but not limited to global import/export requirements for Investigational Product and Returns, regional labeling requirements, cold chain logistics management tools.
• Identify and assess clinical supply chain risks, developing mitigation plans to minimize disruptions to trial execution.
• Proactively manage supply chain issues and implement corrective actions as needed.

Requirements

• Bachelor's degree in a scientific or related field. Advanced degree preferred.
• Minimum of 8 years of experience in clinical supply chain management, with a focus on oncology clinical trials.
• Demonstrated experience in developing and executing clinical supply strategies.
• Strong understanding of GMP, GCP, and other relevant regulations.
• Proven track record in vendor management and risk mitigation.
• Excellent project management, communication, and interpersonal skills.
• Strong analytical and problem-solving abilities.
• Ability to work independently and as part of a cross-functional team.
• Experience with development and launch of Interactive Response Technology (IRT) systems

Benefits

• Competitive salary and benefits package
• Equal opportunity employer
• Values diversity