Senior Medical Director, Late Development

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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.

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  are inquisitive, ask deep questions, and are data-driven innovators who like to collaborate and use team work to move science forward.

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Location:

South San Francisco

We are seeking a Senior Medical Director to join our Clinical Development team.

The Senior 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 late development, 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 offices and required to be onsite four days per week per our company policy.

Reporting to:
Senior Medical Director, Late Clinical Development

• 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 NDA, 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…