Senior Vice President and Chief Medical Officer, Head of Development

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 has an industry leading platform and pipeline in Synthetic Lethality. IDEAYA has established strategic collaborations with Amgen and Pfizer supporting its pipeline programs, and also has wholly-owned or controlled clinical and preclinical programs. For more information, please see www.ideayabio.com.

The Chief Medical Officer will serve as a strategic partner to the Chief Executive Officer and other company Executives and will develop, lead and drive the clinical development and overall development strategy of the company’s current and future pipeline. This individual will serve as a key member of the Executive Committee/Leadership Team and will actively participate in strategic planning, partnering discussions, and presentations to the Board of Directors and investors.
 
This person fulfills a critical and highly visible role, making substantial clinical and medical contributions to the company. The Chief Medical Officer assumes ownership over the company’s clinical and medical affairs and is responsible for ensuring medical excellence in all development efforts.
 
This person is an experienced leader who provides cross-functional leadership and contributes clinical perspective to the research, translational development and regulatory strategies. This person will collaborate closely with research & translational colleagues.

What you'll do:

• Provides medical vision and clinical leadership for the strategy and clinical development plans to advance IDEAYA’s current and future product portfolio to registration.  
• Manages the overall clinical development for lead programs including early development, clinical proof of concept, pivotal studies, regulatory submissions/approvals and product launch.  
• Provides day-to-day practical and overarching strategic guidance for clinical programs, ensuring that the design, implementation and conduct of the company’s clinical studies provide unambiguous data and information that allows for clear decision making and advancement of developmental efforts. 
• Represents IDEAYA at the highest level at the FDA, EMEA and other regulatory agencies.
• Attracts, manages, and retains top talent on the Clinical Development team, which may include Medical/Clinical Science, Clinical Operations, Biostatistics/Data Management, Pharmacovigilance, Regulatory Affairs, GCP Compliance, Clinical Pharmacokinetics and Medical Affairs.
• Maintains understanding of competitors and clinical developments in relevant therapeutic areas by attending scientific meetings and tracking literature.
• Represents and manages the company’s clinical programs to diverse audiences including: FDA or EMEA, shareholders, corporate partners, Board of Directors and other key stakeholders.
• Plays a key role in medical meeting preparation and presentation. Builds and fosters relationships with medical and clinical communities, including the development of indication-specific Clinical Advisory Committees and other forms of strategic consultation. 
• Builds and maintains solid working relationships with key opinion leaders and lead clinical investigators. Establishes and fosters relationships with the international scientific and medical community. 
• Responsible for clinical development strategies, lifecycle management, medical affairs, scientific interactions with regulatory bodies, and interactions with corporate partner(s).
• Leads and oversees the strategic definition and tactical development of   clinical trials programs, including protocol writing, interpretation of clinical data, and literature reviews.
• Ensures the consistent application of state-of-the-art scientific and ethical methods to design clinical trials of the highest quality.
• Ensures that all clinical trials are in keeping with approved timelines and budgets, with potential obstacles identified and solutions implemented to avoid delays in clinical trial implementation.
• Ensures the work with colleagues and collaborators are coordinated and that all people, systems, processes and materials required for clinical trials are available and appropriately prepared.
• Ensures that clinical trials are conducted in accordance with applicable regulatory requirements and guidelines.
• Ensures the identification, recruitment and selection of appropriate clinical investigators and contract research organizations, resulting in appropriate negotiation of contracts.
• Ensures timely medical review and reporting of adverse events.
• Ensures the timely preparation of presentations reporting results of clinical trials to internal and external audiences.
• Collaborates with colleagues in discovery research and preclinical development line functions.
• Participates as an active member of the Executive Committee/Leadership Team of the company.

Requirements:

• MD with Board Certification in Oncology strongly preferred.
• 15+ years of experience in drug development.
• Pharmaceutical industry experience in the successful development of new drug products is strongly preferred.
• A proven success record in Phase I-IV clinical research studies and trial design as well as the successful submission of IND’s and marketing approval-directed filings (BLA’s, NDA’s, and MAA’s).
• Prior experience at senior levels working in and/or leading cross-functional teams.
• Knowledge of relevant FDA regulations and guidelines as well as those of the EU and other health authorities; experience in interactions with FDA personnel is essential; experience in interactions with other health authorities a plus.
• Excellent knowledge of the competitive environment for drugs in the Oncology marketplace and in research and development pipelines.
• Working knowledge of biostatistics as relevant to the design and analysis of clinical trials.
• Team player with executive presence and demeanor coupled with excellent written and verbal communication skills as well as outstanding analytical abilities.
• Comfortable working both internally and externally with technical and medical experts in providing input into future drug development strategies.
• Independent, self-motivated individual with a highly entrepreneurial style coupled with self-confidence and a positive management style.

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
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.

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