Associate Director of Clinical Supply
2 months ago
Summary and Scope:
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 oversee 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.
Guiding Principles: The principles below drive all we do here at Tempest. We seek like-minded individuals who feel passionately about these same principles to join our team.
- 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
Responsibilities (not limited to the below and may evolve over time and change depending on business needs and individual expertise):
- 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 Products and Returns, regional labeling requirements, and 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.
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 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 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 through mechanisms that directly kill tumor cells and activate tumor-specific immunity. The company’s leadership comprises experienced oncology drug discovery and development professionals who share a common goal of advancing novel therapeutics that will bring meaningful benefit to patients.
Tempest is headquartered in Brisbane, CA and is publicly traded on the NASDAQ under the ticker symbol TPST. More information about Tempest can be found on the company’s website at www.tempesttx.com.
Please note this is not a remote position. The right candidate will be onsite at our Brisbane, CA headquarters at least 3 days per week. NO PHONE CALLS or AGENCIES, please.
Tempest offers a competitive salary and benefits package and prides itself on being an awesome place to work. We are an equal-opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender identity, sexual orientation, age, marital status, veteran status, or disability status.
We anticipate the base salary for the Associate Director, Clinical Supply position in our Brisbane, CA office to range from $180,000 to $210,000 and will depend on current market data and the candidate’s qualifications for the role, including education and experience. The compensation described above is subject to change and could be higher or lower than the range described based on several factors.
Qualified candidates should forward a resume and cover letter to: careers@tempesttx.com
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Brisbane, California, United States Tempest Therapeutics Full timeJob Title: Associate Director of Clinical SupplyAt Tempest Therapeutics, we are seeking an experienced Associate Director of Clinical Supply to join our team. This critical role will oversee clinical supply chain activities, ensuring timely and efficient delivery of clinical supplies for our clinical trial programs.Key Responsibilities:Develop and execute...
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