Vice President, Early Oncology Clinical Development

Ideaya BiosciencesSouth San Francisco, CA
107d$328,000 - $405,000Remote

About The Position

IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer. When you're at IDEAYA, you will be in the midst of brilliant minds working on precision medicine therapies to help cancer patients. We are passionate and committed about being on the forefront of oncology medicine, which means we all have a high internal drive that is at the very core of every person at IDEAYA. We are inquisitive, ask deep questions, and are data-driven innovators who like to collaborate and use team work to move science forward.

Requirements

  • Medical degree and medical oncology training required
  • Minimum of ten years of clinical drug development experience
  • Industry experience required
  • Thorough understanding of oncology clinical trial design, including first-in-human Phase 1 studies of small molecules
  • Experience and understanding of clinical trial data monitoring and all aspects of drug development
  • Knowledge of GCP and ICH guidelines
  • Leadership and Management experience highly desirable

Nice To Haves

  • A proven self-starter and team player with strong interpersonal skills who establishes & nurtures highly effective relationships with colleagues and key stakeholders to support and advance project goals and objectives
  • Critical thinker with a solutions-oriented mindset
  • Self-motivated to work effectively in a dynamic environment
  • Possess strong organizational skills and conflict resolution abilities
  • Deep experience and knowledge in oncology clinical development

Responsibilities

  • Oversees all early oncology development program activities and is responsible for execution of programs and timelines
  • Applies disease knowledge to clinical research trial development
  • Drives protocol development for clinical studies in collaboration with Clinical Operations and other clinical subteam functions
  • Drives preparation of clinical development plans in partnership with cross-functional teams
  • Works collaboratively with associated clinical functions to oversee and participate in drafting clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports (DSUR), and other FDA/HA submissions
  • Contributes to CSR preparation and finalization
  • In association with clinical operations colleagues and clinical scientists, contributes to the development of CRFs and data review plans when needed
  • Oversees the Monitoring and review of safety and efficacy data in ongoing studies
  • Serves as the key decision maker for clinical questions associated with eligibility, AE management, etc. for clinical studies
  • Participates in developing clinical abstracts, and/or presents data at scientific meetings, SIVs, and conducts protocol training where needed
  • Develop and participate in advisory boards
  • Keeps abreast of hematology/oncology treatments, drug mechanism of action, approaches to drug development and regulatory requirements
  • Acts as a clinical representative in variety of cross-functional and executive teams
  • Partners with Research, Translational/Biomarker and other Preclinical teams to help guide advancement of drug candidates with meaningful safety: efficacy profiles
  • Serves as clinical partner for Business Development

Benefits

  • Medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents)
  • 401k
  • ESPP
  • Wellness programs
  • Competitive total rewards package reflecting pay-for-performance philosophy

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What This Job Offers

Job Type

Full-time

Career Level

Executive

Industry

Professional, Scientific, and Technical Services

Education Level

Ph.D. or professional degree

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