Senior Manager, Monitoring Quality Oversight

Ideaya Biosciences, Inc.; South San Francisco (CA); On-site; USD 168,000 - 208,000; Full time

Benefits offered by this job

Medical/Dental/Vision coverage

401k

Employee stock purchase plan (ESPP)

Wellness programs

Job summary

IDEAYA Biosciences, Inc. seeks an experienced Monitoring Quality Oversight Manager in Clinical Operations. Lead oversight of CRO monitors and drive data quality across multiple oncology-focused trials. Role is onsite in South San Francisco or San Diego four days per week.

You will provide strategic guidance, manage risk, and contribute to SOPs while collaborating with global teams to ensure trial integrity and compliance with GCP and FDA/EMA guidelines.

Qualifications

• Bachelor’s Degree in life science or equivalent.
• Minimum 6 years of biotech/pharma experience, with 3+ years in monitoring oversight.
• At least 3 years of oncology exposure.
• Strong understanding of GCP, ICH standards, and FDA/EMA guidelines.

Responsibilities

• Conduct monitoring quality oversight visits across North America ensuring protocol and regulatory compliance.
• Generate and implement monitoring QA plans aligned with study objectives and timelines.
• Review monitoring plans to ensure robustness and reflect best practices in clinical monitoring.

Skills

GCP compliance

Clinical operations

CRO management

Oncology

Data analysis

Regulatory guidelines

MS Office

Education

Bachelor’s Degree in life science

Tools

Smartsheet

Clinical trial management systems

Job description

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 [e-mail]. We ask that you only email your interest once.

Job Summary

About 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 teamwork to move science forward. For more information, please see www.ideayabio.com.

Location: South San Francisco, CA or San Diego, CA.

Position Summary

IDEAYA is seeking a talented, experienced, and highly motivated Monitoring Quality Oversight Manger in Clinical Operations with a passion for new cancer therapy development. This role will be responsible for monitoring quality oversight across multiple studies, thus supporting the Clinical Operations team in the operational execution of IDEAYA’s clinical trials.

As a Monitoring Quality Oversight Manager, you will be responsible for the oversight of the Contract Research Organizations (CROs) monitoring activities to ensure the highest standards of data quality and compliance within clinical operations. This role involves a proactive approach to monitoring oversight, including collaboration with CROs and internal teams to identify and mitigate risks, streamline processes, and implement best practices. The successful candidate will have a strong background in clinical operations, excellent analytical skills, and the ability to provide strategic guidance to ensure the integrity of clinical trial data.

As a member of our dynamic adhering group, you will help to grow IDEAYA’s pipeline and you will play a pivotal role in ensuring the quality and integrity of clinical trial data through effective oversight of the CRO monitors.

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

Reporting to: Senior Director, Clinical Operations

What you’ll do:

• Conduct monitoring quality oversight visits across all clinical studies in North America to ensure compliance with study protocols, regulatory guidelines, and company policies.
• Generate and implement comprehensive monitoring quality oversight plans tailored to specific studies, aligning objectives with organizational goals and project timelines.
• Review and assess monitoring plans for each study, ensuring they are robust, comprehensive, and reflective of best practices in clinical monitoring.
• Evaluate monitoring reports in preparation for oversight visits, identify potential issues or trends and developing appropriate action plans for resolution to address any non-compliance or data quality concerns.
• Provide expert guidance and support to clinical operations study teams and service providers on monitoring-related matters, including but not limited to protocol deviations, adverse events, and data quality assessments.
• Conduct risk assessments regarding monitoring activities and develop risk mitigation plans to uphold the quality and integrity of clinical trial data.
• Stay updated on regulatory requirements, guidelines, and industry best practices related to monitoring oversight, ensuring their effective implementation within the organization and advising on necessary changes.
• Assist in the development and maintenance of Standard Operating Procedures (SOPs) related to monitoring oversight, ensuring adherence and compliance across all studies, and updating them as necessary.
• Collaborate with CRO monitors to ensure effective management of monitoring activities while adhering to quality standards and fostering a strong, transparent partnership.
• Maintain tracking of clinical operations monitoring report review metrics and compliance to ensure continuous improvement in monitoring oversight.
• Lead training and development initiatives for study teams and service providers to ensure a clear understanding of monitoring practices, responsibilities, and expectations.
• Prepare and present findings from monitoring oversight activities to senior management, providing insights and recommendations for enhancing the overall quality assurance framework.
• Identify potential areas for process improvement within the monitoring oversight function, implementing changes that promote efficiency, effectiveness, and compliance.
• Monitor adherence to action plans developed during oversight visits and ensure proper follow-up on corrective and preventive actions.
• Coordinate with the quality assurance team to support audits and inspections, ensuring that all documentation and processes meet required standards.

Requirements

• Bachelor’s Degree in life science or equivalent combination of education, training, and relevant experience
• Minimum 6 years of relevant experience in biotech or pharmaceutical industry, of which a minimum of 3 years of focusing on monitoring oversight within a biotech or pharmaceutical setting.
• At least 3 years of experience in oncology.
• Experience in Clinical Operations and a thorough understanding of GCP, relevant ICH standards, and FDA/EMA guidelines.
• Strong understanding of clinical trial processes.
• Proven experience in managing CRO relationships and overseeing monitoring activities.
• Self-motivated, with initiative and able to take ownership of, and follow through with, specific tasks.
• Results-oriented team player; enjoy working collaboratively with colleagues and building positive relationships.
• Exceptional analytical skills, with the ability to assess data and trends effectively.
• Ability to exercise good judgment and make decisions that are appropriate for IDEAYA.
• Ability to demonstrate flexibility and embrace change in a dynamic, rapidly growing environment.
• Excellent communication and interpersonal skills, with the ability to provide clear guidance and support to cross-functional teams.
• Analyze and triage problems, prioritize accordingly, and propose solutions.
• Strive for continuous improvement and embrace innovative ideas in daily work.
• Strong organizational skills and attention to detail, with the ability to manage multiple projects and deadlines.
• Demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint, Adobe Acrobat), clinical trial management systems, data management tools and experience with Smartsheet is a plus.
• Ability to travel up to 80%.

All employees are expected to act with integrity and in full compliance with applicable laws, regulations, and IDEAYA policies, including IDEAYA’s Code of Conduct. Employees must demonstrate good judgement and ethical behavior in all business activities, maintain patient and product safety as a top priority, and report any suspected violations of law or Company policy through appropriate channels.

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 Manager, Monitoring Quality Oversight is $168,000 - $208,000. 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.

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.

We are committed to providing reasonable accommodation to qualified individuals with disabilities. If you need assistance or an accommodation due to a disability, please get in touch with us at [e-mail].