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.

Position Summary:

IDEAYA is seeking a talented, experienced and highly motivated Senior Clinical Trial Manager of Clinical Operations with a passion for new cancer therapy development. This role will be responsible for independently leading the Study Execution Team (SET) and providing oversight of clinical trials for IDEAYA’s clinical programs.

As a Senior Clinical Trial Manager, you will work directly with cross-functional representatives including Medical Monitor, Clinical Science, Clinical Data Management, Regulatory, Biostatistics, Pharmacology and Translational Science and other key functions both internally and externally to ensure successful completion of all clinical activities/project deliverables. You will apply your technical skills and play a key role in clinical trial planning and execution. As a member of our dynamic group, you will help to grow IDEAYA’s pipeline.

What you'll do:

Lead/support SET to ensure trials are initiated efficiently and completed on time, within budget and in compliance with Standard Operation Procedures (SOPs), FDA regulations and ICH/GCP guidelines with minimal supervision
In collaboration with SET, develop, review and facilitate Request for Proposals (RFPs), and contribute to bid defense meetings to select Contract Research Organizations (CROs) and other clinical vendors for the right strategic fit
Manage CRO and/or other clinical vendors to ensure that project and Corporate goals are achieved on time and within budget
Lead development and review key clinical documents (e.g., protocols, informed consent forms (ICFs), case report forms (CRFs), study reference manuals, study plans)
People management: manage and support development of direct and indirect reports by mentoring and delegating responsibilities to junior team members, while overseeing and supporting development plans
Fiscal and contracts management: oversee and manage overall study budget and contracts, forecast financials in partnership with finance, reconcile invoices against accruals, ensure accuracy of all CRO/vendor work order and change order updates
Participate in implementation and oversight of clinical systems including but not limited to CTMS, TMF, EDC and IRT
Clinical data review of data listings and summary tables, including query generation
Oversee site management (e.g., review of monitoring reports, quality metrics) in collaboration with CRO
Lead other study activities as needed (e.g., site selection, start-up, recruitment, protocol deviation and TMF review)
Review and track key study metrics and progress reports; anticipate complex obstacles and clinical trial challenges and implement creative solutions to achieve project goals and timelines
Risk management: Proactively identify potential study risks, recommend mitigation strategies/solutions and facilitate discussions with internal and external stakeholders for implementation
Establish and maintain strong relationships with internal cross-functional teams, CROs and vendors, and clinical research site personnel for successful execution of clinical trials
Train investigators and site staff, vendors and team members on study protocol and trial conduct processes
Ensure the clinical trial(s) are inspection ready at all times and participate

Requirements:

Bachelors in life sciences or related discipline with 8-10 years of experience in clinical and drug development
Advanced knowledge of domestic and global clinical study management and vendor management experience in oncology including interpretation and implementation of FDA and ICH/GCP regulations and guidelines
Early phase oncology trial management experience preferred including precision medicine trials
Self-motivated and strive for continuous improvement and embrace innovative ideas in daily work
Results-oriented team player; enjoy working collaboratively with colleagues and building positive relationships
Detailed oriented and creative thinker with a passion for process optimization
Excellent organizational, analytical and communication (verbal and written) skills in a fast-paced, and rapidly growing dynamic company
Analyze and triage problems, prioritize accordingly, and propose solutions
Ability to travel as required (approximately 20%)

$181,634 - $197,291 a year

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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Senior Clinical Trial Manager