Vice President, Early Oncology Clinical Development

Role Summary

We are seeking a Vice President of Early Oncology Clinical Development to join our IDEAYA’s Clinical Development team. The Vice President of Early Oncology Clinical Development is responsible for providing medical direction, management, and review of clinical trials and product development, including strategy and design of clinical development programs, clinical protocol development, medical monitoring, data analysis, and regulatory documentation. The role may include Development Project Leader responsibilities for specific assets and requires collaboration across functions in a fast-paced environment. Onsite presence four days per week at the South San Francisco headquarters is required.

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 sub-team 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
• Develops and participates 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 cross-functional and executive teams
• Partners with Research, Translational/Biomarker and other Preclinical teams to guide advancement of drug candidates with meaningful safety: efficacy profiles
• Serves as clinical partner for Business Development

Qualifications

• 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

Personal Strengths

• A proven self-starter and team player with strong interpersonal skills who establishes and nurtures 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