Director or Senior Director, Clinical Operations

4 weeks ago

Brisbane, United States Tempest Therapeutics Full time

Summary and Scope:

We are seeking an experienced Director/Sr. Director of Clinical Operations to join our dynamic team and contribute to the development and implementation of both systems and strategic direction towards the conduct of clinical studies, including a pivotal global Phase 3 study for our lead drug candidate, amezalpat. You will play an important role in ensuring the program meets all regulatory and scientific requirements while remaining on time and within budget.


Guiding Principles: The below principles drive all that we do here at Tempest. We are looking for like-minded individuals 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):

  • Provide oversight of studies to ensure clinical trials are conducted in accordance with the protocols, Standard Operations Procedures (SOPs), Good Clinical Practices (GCPs), and other applicable regulatory requirements while meeting corporate goals and timelines within budget.
  • Contribute to the establishment of systems, processes, and infrastructure to support company clinical development activities
  • Work with the team to develop and implement a comprehensive clinical trial plan for the pivotal study, ensuring alignment with overall corporate objectives.
  • Assist or lead, as applicable, clinical operations teams in the selection, contracting, and management of research organizations (CROs) and other trial vendors.
  • Develop and manage clinical trial budgets, forecasting resource needs and monitoring expenditures to ensure adherence to financial plans.
  • Contribute clinical operations expertise in cross-functional meetings; partner effectively with relevant departments such as Project Management, Regulatory Affairs, Quality Assurance, and Finance.
  • Manage relationships with clinical trial investigators and sites, ensuring effective communication and timely site activation and enrollment.
  • Contribute to the preparation and management of all necessary clinical trial documentation, including protocols, investigator brochures, informed consent forms, and regulatory submissions.
  • Proactively identify and mitigate potential risks and challenges to ensure the success of the clinical trial program.


Education, Experience & Qualifications:

  • BS/BA or MS/MA degree preferred in a related discipline
  • Typically requires a minimum of 12+ years of related experience, with a track record of successfully managing large, complex oncology trials.
  • Must be comfortable and effective BOTH as an individual contributor and collaborative team player in a fast-paced and dynamic small-biotech environment, adapting as the company grows.
  • In-depth knowledge of GCP guidelines and regulatory requirements for clinical trials.
  • Uses broad expertise or unique knowledge and skills to contribute to the development of company objectives, processes, and systems to achieve goals in creative and effective ways
  • Excellent project management, communication, and interpersonal skills.
  • Strong analytical and problem-solving abilities.
  • Friendly, positive attitude.


About Tempest Therapeutics:

Tempest Therapeutics is a clinical-stage biotechnology company advancing a diverse portfolio of small molecule product candidates containing tumor-targeted and/or immune-mediated mechanisms with the potential to treat a wide range of tumors. The company’s novel programs range from early research to later-stage investigation in a randomized global study in first-line cancer 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.


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 Director or Senior Director, Clinical Operations position in our Brisbane, CA office to range from $225,000 to $300,000 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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