Senior Director, Regulatory CMC

Non-Solicitation Policy And Notice To Agencies And Recruiters

IDEAYA's Non-Solicitation Policy strictly prohibits agencies and recruiters from any contact and communication with IDEAYA employees, managers, and leaders to submit unsolicited candidate resumes and/or to solicit business partnerships. Submission of unsolicited candidate resumes by agencies or recruiters with or without a contract in place with IDEAYA Biosciences Inc. will not create any implied obligation. Failure to comply with this policy will result in disqualification from current and future business opportunities with IDEAYA Biosciences. All recruiting and talent agency decisions are strictly managed by the internal IDEAYA Human Resources function. All communication by external agencies and recruiters must be directed to [email protected]. We ask that you only email your interest once.

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.

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.

Location: South San Francisco

Position Summary

IDEAYA Biosciences is seeking an experienced, motivated, outgoing leader to head Regulatory CMC. The Senior Director, Regulatory Affairs CMC will support 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 IND's and Marketing Authorization Dossiers 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.

This position is based in our South San Francisco headquarter offices and required to be onsite four days per week per our company policy.

Job Description

What you’ll do:

• Lead the Regulatory CMC function to support 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, CMC and Regulatory Affairs.
• Leads the preparation of CMC documents in response to Health Authority or Agency requests for information
• Manage processes: collaborate cross functionally with teams and departments to generate CMC regulatory documents including reviews and resolution of comments
• Member of program specific regulatory teams
• 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 eCTD s supporting 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
  
  
  

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 CMC team focused on accountability and meeting and exceeding expectations.
• Excellent track record for oncology product approvals in the US and EU preferred
• 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 participation in global Health Authority interactions including leading FDA CMC development review meetings.
• Experience collaborating with CDMOs, contractors and partners is a plus
• 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

• Outstanding interpersonal and communication skills with demonstrated ability to work with cross functional teams comprised of discovery, CMC, quality, regulatory and development teams.
• 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
• Ability to work independently
  
  
  

Total Rewards

Along with our inspiring mission, and highly collaborative and inclusive environment, IDEAYA offers a competitive total rewards package that reflects our pay-for-performance philosophy where employees are eligible to be considered for merit-based salary increases, company discretionary short-term incentive plan participation, and company discretionary stock option awards (based on board approval). Our comprehensive benefits package includes, but is not limited to, medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents), 401k, ESPP, and wellness programs.

The expected salary range for the roleof Senior Director of Regulatory CMC is $238,000-$294,000. 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 opportunities 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 in the office at the Company’s facilities for training & meetings, with 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.

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.