Senior Director of Regulatory Affairs

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Job description

About IDEAYA Biosciences:
IDEAYA Biosciences (NASDAQ: IDYA) is a public, clinical-stage synthetic lethality-focused precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using DNA sequencing and other molecular diagnostics. 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 are applying these capabilities across multiple classes of precision medicine, including 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 recently announced a landmark strategic partnership with GSK in Synthetic Lethality for certain pipeline programs. The GSK partnership is transformative and enables IDEAYA and GSK to collectively build an industry leading platform and pipeline in Synthetic Lethality. For more information, please see .

Position Summary:
IDEAYA Biosciences is seeking an experienced, motivated, outgoing leader to head Regulatory Affairs. This person will be responsible for development of US and rest of world regulatory strategy for IDEAYA's oncology pipeline and to represent Regulatory Affairs on project teams. The individual must have knowledge of regulatory requirements in major regions (US, EU) with responsibility to form a global strategy, including in Asia; Develops and maintains communications with FDA and coordinates interaction with regulatory agencies worldwide.

Key Duties And Responsibilities:

• Develops regulatory strategic plans for project teams. Works with project teams to resolve complex project issues. Supports team interactions and alignment with partner. Utilizes expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure governmental approvals are obtained. Represent IDEAYA before regulatory authorities.
• Assists in the design and interpretation of results for Clinical Studies required for Regulatory Approvals.
• Responsible for filing of IND/CTA, NDA/BLA/MAA submissions. Sets strategy for submissions of product registration documents to health authorities worldwide. Interacts with other line functions in the preparation, review, and completion of documents for regulatory submissions.
• Responsible for keeping management team informed of regulatory status of programs and significant regulatory issues. Able to present and implement project related regulatory strategy with all Project Teams. Assures compliance with project team timelines and milestones.
• Effectively plans, organizes, and conducts (or supervises) formal meetings with regulatory agencies. Interacts with key personnel in regulatory agencies to ensure the review and approval of development plans, the timely resolution of issues, and the approval of marketing applications.
• Provides counsel, training, and interpretation of FDA's and other regulatory authorities' feedback, policies and guidelines to IDEAYA and assists as a liaison between IDEAYA and regulatory authorities.
• Provides interpretive analyses of complex regulatory guidance documents, regulations, or directives that influence IDEAYA's products and operations. Advises personnel in other departments regarding their applicability and impact.
• Manages a team in Regulatory Affairs & Operations and has working knowledge of the Regulatory Operations function and submission logistics
• Has working knowledge of regulatory issues that pertain to CMC

Requirements:

• Bachelor's degree in a Life Sciences discipline or equivalent, with advanced degree (MS/PhD/PharmD) preferred.
• Minimum of ten (10) years of experience in clinical regulatory and high potential for progressive senior leadership roles. Oncology experience highly valued.
• Proven ability to develop and manage a high-performance regulatory team focused on accountability and meeting and exceeding expectations.
• Excellent track record for oncology product approvals in the US and EU preferred
• Experience developing companion diagnostic regulatory strategy preferred
• Extensive experience in cGMP and other Regulatory (CMC, preclinical) compliance requirements.
• Balance of strategic thinking and strong analytical skills with ability to execute.
• Experience with international regulatory submissions and an understanding of worldwide guidelines and regulations preferred.

Essential Skills and Abilities:

• Demonstrated excellence in regulatory liaison/strategy & effective negotiations with regulatory authorities
• Strategic thinking, leadership skills, assertiveness, strong technical background, and project management skills as evidenced by past performance on drug development project teams
• Able to analyze worldwide regulatory requirements to synthesize a global regulatory development strategy as evidenced by past regulatory experience
• Excellent interpersonal skills
• Excellent communication skills (verbal and written) as evidenced by a demonstrated ability to prepare complex documents / submissions and to give presentations
• Management experience is preferred
• Ability to work independently
• Ability to travel (approximately estimated 10% travel required)

The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position requires you to work onsite at the Company's facilities and the Company requires that all employees working in its facilities be fully vaccinated (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for medical or religious reasons, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.

Benefits
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.

Ideaya is an equal opportunity employer. In accordance with applicable law, Ideaya does not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status. EOE/AA/Vets.