Associate Director, Clinical Operations - #2120

GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC is a wholly-owned subsidiary of Illumina, Inc. (NASDAQ:ILMN). For more information, please visit www.grail.com.

The Associate Director of Clinical Operations will be accountable in providing oversight and execution of
multiple clinical studies including overseeing all operation activities of the CRO vendor, study planning,
budgeting, study timelines, and ensuring compliance with GCP.
You will:

• Oversee execution of all operational aspects of one or more clinical studies.
• Oversee the identification and mitigation of study risks to study implementation, enrollment, conduct, and compliance.
• Provide operational input in site selection, protocol development, data collection, study timeline, and study budget.
• Leads the study team through the vendor selection process and serves as an escalation point for any CRO vendor related issues.
• Participates in the development of Clinical Operations and cross functional SOPs and provides strategic direction in the development and implementation of process changes.
• Identify and provide solutions and direction related to key cross-functional, site, and CRO clinical study issues.
• Ensure operational feasibility of clinical study plans and scenarios, including timeline, budget and resource requirements.
• Determines participant recruitment strategies, operational feasibility and implementation path of the study/program objectives; manages and communicates to senior management and key stakeholders.
• Oversee the quality of clinical programs and deliverables and ensure all study activities are completed in accordance with ICH GCP, health authority regulations and SOPs.
• Lead the team through inspection readiness activities and address any audit findings appropriately and promptly.
• Recruits, hires, mentors, and manages CPA, CTM, and CPM direct reports, and supports their professional development.
• Provides leadership, guidance, and direction to the Clinical Operations study team.
• Clinical Operations representative in cross functional working groups and study team meetings.
• Partners with key stakeholders such as Legal, Finance, Biosample Management, Clinical Data Management, Regulatory Affairs, Compliance, and Clinical Development.

Your background should include:

• Bachelor’s degree or equivalent in the life sciences or related field required. Additional coursework in clinical trial planning and execution is strongly desired.
• Ideal candidate will have at least 8 years of relevant experience in managing clinical trials (minimum 4 years of managerial experience) in sponsor organizations with a strong track record of successful trial initiation and execution.
• Demonstrated ability to independently manage the initiation, monitoring and closing of clinical studies
• Demonstrated extensive understanding of clinical trial processes, and technical expertise in driving execution, from study start-up through study closure
• Industry experience within in vitro diagnostics (IVD) highly preferred; pharmaceutical, biologics or medical device experience also acceptable.
• Thorough knowledge and understanding of FDA and/or EMA regulations (or relevant local regulations), ICH Guidelines and GCPs governing the conduct of clinical trials.
• Working experience with an electronic data capture system, CTMS system, and eTMF system.
• Strong interpersonal communication (written and verbal), organizational and prioritization skills.
• Able to work effectively under a fast-paced and changing environment.
• Strong work ethic and demonstrated ability to deliver assignments on time.
• Proficient with office automation tools, such as Microsoft Office and the Google suite of apps

GRAIL is an Equal Employment Office and Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, GRAIL has made the decision to require all U.S. employees receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.