Director/Senior Director, Regulatory Affairs CMC

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 HR@ideayabio.com

Position Summary:

The Director/Senior Director, Regulatory Affairs CMC will lead the CMC Regulatory Affairs function and be responsible for planning and executing the CMC regulatory strategies for IDEAYA’s therapeutic development programs.  This position will define the CMC regulatory strategy in partnership with main stakeholders and manage processes that are required to plan and execute CMC regulatory strategies.  You will be working in close collaboration with pharmaceutical development colleagues.  You will be responsible for the Module 3 (Quality) of our Marketing Authorization for IDEAYA portfolio.  This position will provide leadership at a product level ensuring first pass global approvals of CMC regulatory submissions.  Additionally, you will be accountable for leading the interpretation and implementation of CMC regulatory guidelines, regulations and current environment to assure approvability in high priority regions.  The role will report directly to Vice President of Regulatory Affairs.

• Lead the Regulatory CMC function to support for projects in development and the CMC portfolio goals
• Lead the execution of global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in PDM, Regulatory Affairs, and Clinical Development.
• Leads the preparation of CMC documents in response to Health Authority or Agency requests for information, meeting briefing books to support Scientific Advice interactions
• Manage processes: collaborate cross functionally with teams and departments to generate CMC regulatory documents including reviews and resolution of comments
• Proactively partners with Technical Operations, Manufacturing, and Quality counterparts on processes and program prioritization; Ensures cross-functional alignment on regulatory plans and strategies
• Effectively manage regulatory CMC aspects of the preparation and submission of CMC sections of dossiers supporting clinical trial applications (i.e. IND/IMPD/CTA submissions), annual reports and marketing applications.
• Exercise expertise in the interpretation and implementation of ICH guidelines with a goal of an approved/ harmonized regulatory control strategy.
• Facilitates the development of, reviews, and comments on all technically complex CMC documentation for submission to regulatory authorities including process development, process validation, comparability studies, analytical method development, and analytical method validation supporting establishment of specifications and in-process, release and stability data including expiry dating and information appropriate to phase of development.
• Anticipate risks and lead internal discussions to find innovative solutions for the identified risks, including assessment and communication of probabilities of technical and regulatory success
• Articulates complex CMC regulatory issues to project teams and external stakeholders to support global development and commercialization of drug candidates
• Exercise expertise in the interpretation and implementation of ICH guidelines with a goal of an approved/ harmonized regulatory control strategy.

• A scientific degree with directly relevant industry experience of 10 years, of which at least 8 years spent in regulatory affairs with CMC responsibilities with a BA/BS, MA/MS, PhD or PharmD
• Outstanding interpersonal and communication skills with demonstrated ability to work with cross functional teams comprised of discovery, process development, quality and manufacturing.
• Thorough understanding of drug development process and the pharmaceutical industry and healthcare environment including regulatory requirements, guidance, accelerated regulatory review paths, and policy trends
• Demonstrated knowledge of eCTD elements, structure and content; expertise in Module 3
• Prior direct, hands-on experience in the preparation and oversight of CMC submissions (INDs, IMPDs, NDAs and/or MAAs)
• Experience with leading global Health Authority Interactions including leading FDA CMC development and NDA review meetings.
• Experience collaborating with CDMOs, contractors and partners is a plus
• Proven ability to work successfully and influence within a cross-functional team/partnership environment with a high level of professionalism
• Demonstrated organizational leadership skills at a functional level.
• Excellent attention to detail with strong verbal and written business communication skills
• Knowledgeable in US, EU and key International regulatory guidelines
• Strong communication and collaboration skills
• RAC certification

The salary range for this position at the Director level is between $227,566 and $266,332.  The salary range is an estimate and may vary based on the Company’s compensation practices.

The salary range for this position at the Senior Director level is between $269,362 and $309,140.  The salary range is an estimate and may vary based on the Company’s compensation practices.

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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