Vice President, Early Development Clinical Operations

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Job Summary

About IDEAYA Biosciences:

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.

Notice to Agencies and Recruiters:
All open positions and candidate activity are strictly managed through IDEAYA Biosciences, Inc’s Human Resources department. 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 by agencies, with or without an agreement in place with IDEAYA Biosciences, Inc., will not create any implied obligation. Please note that failure to comply with this policy will be a factor in developing or continuing a professional relationship with IDEAYA Biosciences, Inc.

Position Summary

We are seeking a dynamic and experienced Vice President of Early Development Clinical Operations. This individual will be responsible for leading and executing the clinical operations strategy within early clinical development. The ideal candidate will possess a deep understanding of and demonstrated track record for execution of early stage clinical operations programs, as well as a proven leadership track record as a strong collaborator with late stage colleagues to ensure seamless transition of programs from early to late stage.

This position reports to the Chief Medical Officer. This role is based in IDEAYA’s South San Francisco, California office with an expectation to be in the office 4 days a week.



Job Description

What you’ll do:

• Provide leadership, therapeutic expertise and guidance on early development clinical operations activities to ensure quality, resource, budget and timeline goals are met.
• Collaborate with Medical Directors/Clinical leaders and the project teams on developing the clinical operational strategy and accomplishing high-quality data deliverables.
• Set clinical operations vision within early clinical development including expectations for the team, clarifying accountabilities and leading team to achieving its goals.
• Establish performance indicators to ensure the successful execution of clinical trial deliverables.
• Represent early development clinical operations and provide updates to the program team and executive leadership.
• Plan and implement quality checks for clinical projects; provide leadership and direction to ensure the highest standards for compliance with pharmaceutical regulatory requirements; develop a pro-active approach for inspection readiness.
• Contribute to the development of INDs, protocols, informed consents and other clinical / regulatory / safety documents.
• Develop and maintain strong relationships with internal cross-functional teams, CROs, and clinical research site personnel to ensure effective execution of clinical trials.
• May function as executive sponsor for preferred vendor/CRO relationships.
• Recruit, hire, mentor, and manage direct reports as required and support their professional development.
• Initiate and lead departmental or interdepartmental strategic initiatives to further strengthen the organization.

• Bachelors in Life Sciences, Nursing Licensure or Pharmacy; an advanced degree in a relevant scientific discipline is preferred.
• A minimum of 15 years of experience working in the biotech/pharmaceutical industry in the Clinical Operations function
• A minimum of 10 years of in the oncology therapeutic area with proven expertise in early development clinical operations setting strategy, planning, implementing, and conducting early phase clinical trials.
• A minimum of 10 years of people management experience.
• Small, mid-size,and large company clinical operations experience required. Direct relevant experience leading this function within a small to mid-size pre-commercial stage biotech company is desired.
• Proven leadership in developing a high-performance clinical operations group; setting expectations, creating…