Brisbane, CA
Medical Director/Senior Medical Director
Reports to: Chief Medical Officer and Head of R&D
Department: Clinical Development
Department Head: Chief Medical Officer and Head of R&D
Summary and Scope:
We are seeking a highly motivated and experienced Medical Director or Senior Medical Director to join and help lead our clinical development team. In this leadership position, you will play a key role in the strategic direction and medical oversight of our oncology pipeline. You will provide expert medical guidance and ensure the scientific integrity and ethical conduct of our clinical trials. This 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 are looking for like-minded individuals that 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
(duties are not limited to the below and may evolve over time and change depending on business needs and individual expertise)
- Collaboratively lead medical aspects of our clinical development programs, from early to late-stage trials.
- Partner with clinical, operations, statistics, research, and regulatory colleagues to
- Guide strategy for Tempest’s oncology pipeline from pre-IND to pivotal development
- Implement strategy to (i) successfully advance Tempest’s therapeutics and (ii) help patients.
- Educate and advise clinical site investigators and study staff to support study interest, enrollment and optimal study conduct
- Contribute to the development of clinical trial materials, including protocols, investigator brochures and informed consent documents.
- Oversee medical monitoring activities to ensure patient safety and data integrity.
- Review and analyze clinical trial data; prepare reports and presentations for internal and external stakeholders.
- Contribute to US and Global (as needed) regulatory agency submissions and meetings.
- Build relationships with KOLs to bring expertise to Tempest programs and to support external awareness of Tempest drugs and data.
- Stay current on relevant scientific advancements and clinical trial landscape in oncology.
- Represent the company at medical conferences and scientific meetings.
Education, Experience & Qualifications:
- MD or DO degree; clinical experience and/or board certification in Medical Oncology or Hematology/Oncology a plus
- Minimum 10+ years of experience in the pharmaceutical or biotechnology industry with broad experience leading and managing clinical trial programs from early to late stage.
- Pivotal study management and global submission (e.g., NDA, MAA) experience a plus
- Excellent understanding of and experience with clinical trial design (e.g., phase 1, 2 and 3, dose escalation and/or optimization, S2S, randomized), regulatory requirements , and Good Clinical Practice (GCP) principles.
- 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.
- Excellent writer and oral communicator; strong interpersonal, leadership and people-management skills.
- Flexible and creative thinker and problem-solver
- Ability to work independently and manage multiple priorities in a fast-paced environment.
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.
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.
Qualified candidates should forward a resume and cover letter to: careers@tempesttx.com
Please note this is not a remote position. NO PHONE CALLS or AGENCIES, please.