Senior Clinical Trial Manager

IDEAYA Biosciences (NASDAQ: IDYA) is a public, clinical-stage precision medicine oncology company committed to the discovery, development, and commercialization of targeted therapeutics for patient populations with high unmet clinical needs. 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 have developed an industry leading platform and pipeline in precision medicine by applying these capabilities across multiple approaches such as 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 established strategic collaborations with GSK, Merck, Pfizer, and Gilead but wholly-owns or controls its four most-advanced clinical programs and we are committed to building a best-in-industry organization to deliver our precision medicines to the people who need them.

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 teamwork 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:

IDEAYA is seeking a talented, experienced and highly motivated Study Lead 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 Study Lead, 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.

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

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)
• 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
• Demonstrate command of study status and proactively communicate issues or changes that may impact quality, timelines and costs to Clin Ops management and key stakeholders
• 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
• Partner with cross functional stakeholders to identify and remove executional barriers in order to ensure timelines and goals are met
• Collaboratively drive cross functional decision-making while ensuring clarity and timely communication once consensus is reached
• Aggressively manage issues that have been escalated by other Clin Ops team members, cross functional stakeholders, vendors, CROs and other study partners to efficient closure
• 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 in Quality Assurance and/or regulatory authority inspection audits, as needed
  
  
  
  
  

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 (up to 40%)
  
  
  
  
  

At IDEAYA Biosciences, we care about our employees and strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health and well-being benefits. The expected salary range for this role that is based in our South San Francisco/San Diego, California office is $165,308 - $204,204. 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 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.

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.

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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