Senior Clinical Trial Manager - South San Francisco, United States - IDEAYA Biosciences
Description
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 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 supervisionIn 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 fitManage CRO and/or other clinical vendors to ensure that project and Corporate goals are achieved on time and within budgetLead development and review key clinical documents (e.g.
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 plansFiscal 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 updatesParticipate in implementation and oversight of clinical systems including but not limited to CTMS, TMF, EDC and IRTClinical data review of data listings and summary tables, including query generationOversee site management (e.g., review of monitoring reports, quality metrics) in collaboration with CROLead 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 timelinesRisk management:
Proactively identify potential study risks, recommend mitigation strategies/solutions and facilitate discussions with internal and external stakeholders for implementationEstablish and maintain strong relationships with internal cross-functional teams, CROs and vendors, and clinical research site personnel for successful execution of clinical trialsTrain investigators and site staff, vendors and team members on study protocol and trial conduct processesEnsure the clinical trial(s) are inspection ready at all times and participateRequirements:Bachelors in life sciences or related discipline with 8-10 years of experience in clinical and drug developmentAdvanced 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 guidelinesEarly phase oncology trial management experience preferred including precision medicine trialsSelf-motivated and strive for continuous improvement and embrace innovative ideas in daily workResults-oriented team player; enjoy working collaboratively with colleagues and building positive relationshipsDetailed oriented and creative thinker with a passion for process optimizationExcellent organizational, analytical and communication (verbal and written) skills in a fast-paced, and rapidly growing dynamic companyAnalyze and triage problems, prioritize accordingly, and propose solutionsAbility to travel as required (approximately 20%)$181,634 - $197,291 a yearThe 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.
BenefitsAlong 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.
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