Senior Director/Vice President, Regulatory Affairs
Legal, Sales & Business Development
San Diego, CA, USA
Posted on Wednesday, July 26, 2023
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-owner controls its three most-advanced clinical programs. It has established strategic collaborations with GSK, Amgen and Pfizer 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.
IDEAYA Biosciences is seeking an experienced and motivated person to join Regulatory Affairs. This person will participate in the development of US and rest of world (RoW) 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) in oncology with responsibility to form a global strategy, including in Asia; this person will develop and maintain communications with FDA and coordinate interactions with regulatory agencies worldwide.
This person is responsible for developing and directing IDEAYA's regulatory strategy, objectives, policies, and programs from IND planning through NDA and future commercialization. This position will serve as the regulatory lead for IDEAYA developing and providing strategic regulatory direction and guidance to R&D on corporate projects and key strategic business initiatives to achieve corporate objectives. This role will also drive the operational aspects of regulatory compliance and submissions for all programs including CMC, discovery, preclinical, and clinical. This position will report to the Chief Medical Officer and will work with cross functional teams including Development, QA, Clinical, and Business Development.
This position is based in South San Francisco, CA. or San Diego, CA.
What you'll do:
- Develops regulatory strategic plans for project teams to gain earliest regulatory approvals in US, EU, Japan and RoW. Works with project teams to resolve complex project issues. Supports team interactions and alignment with partners. Utilizes expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure governmental approvals are obtained. Represents 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.
- Bachelor’s degree in a Life Sciences discipline or equivalent, with advanced degree (MS/PhD/PharmD) preferred.
- Minimum of ten to fifteen (10-15) years of relevant clinical regulatory leadership experience in biopharma industry. Oncology experience required.
- Proven track record of success in supporting successful Phase I-III clinical trials and progressing programs including INDs, early and late-stage development plans to completion with FDA
- Excellent track record for oncology product approvals in the US and EU preferred. Proven success in communicating to and negotiating with FDA and global health authorities and managing clinical trial applications in several geographies around the world.
- Proven ability to develop and manage a high-performance regulatory team focused on accountability and meeting and exceeding expectations. Also experienced in building the regulatory infrastructure needed in a maturing biopharma company.
- 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 salary range for this position at the Senior Director level is between $258,861 and $306,494. The salary range is an estimate and may vary based on the Company’s compensation practices.
The salary range for this position at the Vice President level is between $330,100 and $375,500. 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.
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.