Associate Director of Clinical Operations

7 days ago

Brisbane, California, United States Tempest Therapeutics Full time
Job Title: Associate Director of Clinical Operations

We are seeking an experienced Associate Director of Clinical Operations to join our team at Tempest Therapeutics. This role will play a critical part in overseeing clinical supply chain activities, from forecasting and planning to packaging, labeling, and distribution.

The successful candidate 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.

About the Role:

  • 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, including IRT and potentially fulfill roles on unblinded sponsor representatives as 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.

About You:

  • 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.

What We Offer:

Tempest Therapeutics offers a competitive salary and benefits package, as well as the opportunity to work with a talented team of professionals who share a common goal of advancing novel therapeutics for cancer patients. The base salary for this position is estimated to be between $180,000 and $210,000 per year, depending on current market data and the candidate's qualifications.

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