Vice President Regulatory Affairs

SUMMARY AND SCOPE:

We are seeking a strategic and results-oriented leader to oversee all regulatory activities for our immuno-oncology pipelines, with an initial focus on the upcoming Phase 3 clinical trial for our lead candidate, Amezalpat (TPST-1120). You will be responsible for developing and implementing comprehensive regulatory strategies to ensure timely and successful interactions with global health authorities. The position will report to our Chief Medical Officer and Head of R&D.

GUIDING PRINCIPLES:

The below principles drive all that 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):

• Lead the development and execution of global regulatory strategies for each of Tempest’s programs/molecules.
• Contribute to company culture, strategy, and operations as a member of the Tempest Management Team.
• Oversee the preparation and submission of all global regulatory filings, including INDs, CTAs, Investigator's Brochures (IBs), DSURs, and NDAs.
• Manage electronic submission vendor.
• Maintain company records of all submissions and correspondence.
• Work with head of CMC to oversee regulatory strategies and regulatory submissions (INDs/IMPDs) for investigational drug products.
• Serve as the primary point of contact for global regulatory authorities (e.g., FDA, EMA, NMPA, PMDA, etc.), leading all communications and meetings.
• Strategize, lead, write, and/or supervise the development and submission of documents or plans (e.g. Orphan, Break-Through, Fast-Track, Accelerated-Approval, Diversity, and Pediatric Plans) to regulatory agencies to support development goals.
• Collaborate with cross-functional teams (Clinical Development, CMC, Quality Assurance) to ensure regulatory compliance throughout the development process.
• Provide expert guidance and support to internal stakeholders on all regulatory matters.
• Stay current on relevant evolving global regulations and guidance.
• Develop and manage the Regulatory Affairs department budget.
• Maintain active INDs/CTAs.
• Manage and collaborate with consultants and CRO partners involved in preparing US and Ex-US regulatory submissions.

EDUCATION, EXPERIENCE & QUALIFICATIONS:

• Advanced Degree (PhD, PharmD, MD) in a scientific discipline or equivalent experience.
• Minimum 10 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry, with a strong track record of success in late-stage oncology drug development.
• In-depth knowledge of global regulatory requirements with a particular focus on the FDA, EMA, NMPA, and PMDA.
• Extensive experience in the preparation and submission of INDs, CTAs, and other regulatory filings (e.g. Orphan, Break-Through, Fast-Track, Accelerated-Approval, Diversity, and Pediatric Plans) including for global development; strongly prefer previous Phase 3 NDA experience.
• Excellent writer and oral communicator; strong interpersonal, leadership, and people-management skills.
• Must be comfortable and effective as BOTH an individual contributor and collaborative team player in a fast-paced and dynamic small-biotech environment, and throughout the company’s growth.
• Flexible, creative thinker and problem-solver.

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 benefit 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 anticipate the base salary for the Vice President, Regulatory Affairs position in our Brisbane, CA office to range from $325,000 to $375,000 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. 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.

Qualified candidates should forward a resume and cover letter to: careers@tempesttx.com

Please note, this is not a remote position. No agencies, please.