Medical Director (early Development)

IDEAYA Biosciences (NASDAQ: IDYA) is a public, clinical-stage precision medicine oncology company committed to the discovery, development, and commercialization of targeted therapeutics for patient populations with high unmet clinical needs. Our approach integrates extensive capabilities in identifying and validating translational biomarkers with small molecule drug discovery to select patient populations most likely to benefit from the therapies we are developing. We have developed an industry leading platform and pipeline in precision medicine by applying these capabilities across multiple approaches such as direct targeting of oncogenic pathways and synthetic lethality, which represents an emerging class of precision medicine targets. We believe this diversified approach will enable us to deliver the right medicine to the right patient to drive a more robust clinical response. IDEAYA has established strategic collaborations with GSK, Amgen, Pfizer, and Gilead but wholly-owns or controls its three most-advanced clinical programs and we are committed to building a best-in-industry organization to deliver our precision medicines to the people who need them.   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 teamwork to move science forward. For more information, please see www.ideayabio.com.

Notice to Agencies and Recruiters: All open positions and candidate activity are strictly managed through Human Resources.  Please note that our policy is that recruiters do not contact employees/hiring managers directly to solicit business and/or present candidates. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Please note that failure to comply with this request will be a factor in developing a professional relationship with IDEAYA Bio.  Inquiries regarding developing a recruiting relationship with us, may be directed to HR@ideayabio.com

Position Summary: The Medical Director is responsible for providing medical direction, management and review of clinical trials and product development.  Specific tasks may include design of clinical development program plans, as well as clinical protocol development, medical monitoring of clinical trials, and analysis of study data and preparation of trial reports and related regulatory documents.  The individual may also serve as a Development Project Leader for a specific asset and will interact with most functions to ensure the successful progress of projects and clinical trials. This individual will have a solid understanding of all phases of clinical drug development with particular expertise in first in human clinical trials, translational science, and operational excellence.  Excellent written and effective verbal communication skills, ability to influence across functions and levels, and flexibility/adaptability to work in a fast-paced environment are essential. This position is based in our South San Francisco headquarter or San Diego office and required to be onsite four days per week per our company policy.

What you'll do:

• 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 team
• Works collaboratively with Regulatory Affairs; drafts clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports (DSUR), and other FDA/HA submissions
• Contributes to CSR preparation and finalization
• Contributes to development of CRFs and data review plans
• Monitors, and reviews safety and efficacy data in ongoing studies
• Serves as primary clinical point of contact (eligibility questions, AE management…) for clinical trial sites
• Develops clinical abstracts, and/or presents data at scientific meetings, SIVs, and conducts protocol training
• 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 variety of cross-functional teams, including early stage Research teams
• Serves as clinical partner to Business Development

Requirements:

• Medical degree required; hematology/oncology training and/or practice experience
• Experience in industry in early phase development preferred
• Thorough understanding of oncology clinical trial design, including first-in-human Phase 1 studies as well as mid and late-stage trials
• Experience and understanding of clinical trial data monitoring and all aspects of drug development
• Knowledge of GCP and ICH guidelines
• 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