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 humanresources@ideayabio.com. We ask that you only email your interest once.Job SummaryAbout 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, CA.Position Summary:IDEAYA is seeking a talented, experienced and highly motivated Senior Clinical Trial Manager 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. This position is based in our South San Francisco headquarter offices and required to be onsite four days per week per our company policy.Reporting to: Vice President, Clinical Operations Early DevelopmentJob Description
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%)
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 role of Senior Clinical Trial Manager is $166,000 - $205,000. 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.
