Associate Director of Clinical Supply
Company: Tempest Therapeutics
Location: Brisbane, CA
Type: Full-time, Hybrid (Onsite 3 days/week)
Compensation: $180,000 - $210,000/year
Summary and Scope:
The Associate Director of Clinical Supply plays a pivotal role in ensuring the timely and efficient delivery of clinical supplies for Tempest Therapeutics' oncology clinical trial programs. This position involves overseeing clinical supply chain activities, from forecasting and planning to packaging, labeling, and distribution. The successful candidate will collaborate closely with internal and external stakeholders to ensure clinical supplies meet regulatory requirements and support trial execution.
Guiding Principles:
Develop meaningful therapies for patients.
Value diversity in building teams.
Commit to growth and collaboration.
Work with integrity and rigor.
Embrace the energy that drives a successful biotech.
Key Responsibilities:
Develop and execute clinical supply strategies aligned with trial protocols, regulatory requirements, and company goals.
Collaborate with cross-functional teams to establish supply forecasts, inventory plans, and distribution strategies.
Oversee selection and management of clinical supply vendors, including IRT and unblinded sponsor roles when 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 CDMOs, packaging providers, logistics partners, and ancillary sourcing vendors.
Monitor vendor performance using KPIs and ensure compliance with quality standards and project timelines.
Identify and implement opportunities for continuous improvement in clinical supply chain processes.
Stay current with industry trends and best practices, including import/export requirements, regional labeling, and cold chain logistics.
Identify and assess clinical supply chain risks, developing mitigation plans to minimize disruptions.
Proactively manage supply chain issues and implement corrective actions as needed.
Education, Experience & Qualifications:
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 relevant regulatory requirements.
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 within cross-functional teams.
Experience in the development and launch of Interactive Response Technology (IRT) systems.
About Tempest Therapeutics:
Tempest Therapeutics is a clinical-stage biotechnology company developing small molecule therapeutics to treat cancer by targeting tumor-specific immunity and directly killing tumor cells. The company’s leadership consists of experienced oncology drug discovery and development professionals committed to advancing novel therapeutics that bring meaningful benefits to patients.
Tempest is headquartered in Brisbane, CA, and is publicly traded on the NASDAQ under the ticker symbol TPST. More information can be found at www.tempesttx.com.
Work Environment and Expectations:
This is not a remote position; the candidate will be onsite at the Brisbane, CA headquarters at least 3 days per week.
No phone calls or agencies, please.
Compensation and Benefits:
Competitive salary ranging from $180,000 to $210,000/year, depending on market data, education, and experience.
Comprehensive benefits package.
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