Senior Director, Regulatory Affairs

IDEAYA Biosciences (NASDAQ: IDYA) is a public, clinical-stage 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 has an industry leading platform and pipeline in precision medicine / synthetic lethality. IDEAYA wholly-owns or controls its three most-advanced clinical programs.  It has established strategic collaborations with GSK, Amgen, Pfizer and Gilead supporting certain clinical and preclinical pipeline programs. 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. 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 ******** 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.  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.
\n What you'll do: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 in support of filing of IND/CTA, NDA/BLA/MAA submissionsHas 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 leadership roles.   Oncology experience preferred.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 preferredExperience developing companion diagnostic regulatory strategy highly valuedBalance 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 authoritiesStrategic 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 Ability to work independently Ability to travel (approximately estimated 10% travel required) 
\n$263,118 - $279,245 a year
\nAt IDEAYA Biosciences, we care about our employees and strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health and well-being benefits. The expected salary range for this role that is based in our South San Francisco, California office and San Diego, California is
- Senior Director level: $263,118 - $279,245
The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the office location where this open position is located, the final candidates' experience within their profession, experience in the disease areas we are striving to make an impact in as a company, length of time within the industry, educational background, and performance during the interview process. 
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, with partial work-from-home flexibility,  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
Along with our highly collaborative and inclusive environment, IDEAYA offers a comprehensive and competitive benefits package that includes (but is not limited to) medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents), retirement benefits, ESPP and wellness programs. All full-time employees will also be eligible for an annual bonus and equity refresh. 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.
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