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Senior Clinical Trial Manager

Employer
IDEAYA Biosciences
Location
South San Francisco, CA
Start date
Apr 15, 2024

View more

Discipline
Clinical, Clinical Research, Clinical Trials
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay

Job Details

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%)

$175,000 - $196,772 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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Company

Founded in 2015, IDEAYA Biosciences 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.

Stock Symbol: IDYA

Company info
Website
Phone
650-443-6209
Location
7000 Shoreline Court
Suite 350
South San Francisco
California
94080
US

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