GRAIL

GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured.

Menlo Park, CA, USA

Hybrid

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Jobs//Hybrid//Peninsula//Operations//

Associate Director Safety & Data Integrity, Strategy and Execution #3716

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Employer Provided Salary: 159,000-199,000 Annually

The Associate Director, Safety & Data Integrity Operations will partner with the Head of Safety, & Data Integrity Officer to develop and deploy a robust Safety & Data Integrity program at GRAIL. The Associate Director will work cross-functionally to implement Safety & DI strategy; prepare the program overview and education, collaborate on deployment of policies into functional SOPs, setup governance structure, and build infrastructure to operationalize the programs.

This position is based in Menlo Park, California and will be working in the office on a hybrid basis two days a week.

Responsibilities:

Develop, Implement, and Continuous Improvement of Safety and Data Integrity Policy, and procedures to ensure compliance with regulatory requirements and best practices
Conduct regular assessments to identify potential risk areas, and areas of improvement
Collaborate to build lead training sessions to promote awareness and adherence to Safety & Data Integrity guidelines
Collaborate with cross-functional teams to integrate safety and data integrity into all aspects of GxP systems and processes.
Stay informed about emerging safety trends, and technologies to proactively identify opportunities for enhancing safety and data integrity programs and practices.
Build a central repository of safety events, and create periodic reports to identify trends, and signals.
Define, create, and communicate metrics for Safety & Data Integrity, and establish governing mechanisms for periodic monitoring and communication.
Work with Complaint Handling, MSL, and other functions on triaging of safety related complaints, and appropriate regulatory reporting.
Manage investigation and analysis of incidents and near misses to identify root cause and develop corrective and preventive actions.
Foster a culture of safety by promoting open communication, employee engagement, and accountability of safety and data integrity.

Preferred Qualifications:

B.S./B.A. in a science or related life science field; advanced scientific degree desired.
10 + years experience in any of the following industries (preferred): direct In Vitro Diagnostic, medical device or pharma industry.
Experience in building programs from ground up, and setting up governance and building infrastructure to operationalize.
Familiarity with Quality Management Systems in medical devices, life sciences industry and understanding of safety risk management, and GxP compliance.
Work with data to create trending reports, and identify potential signals.
Lead and drive continuous improvement (training in lean sigma, six sigma preferred)
Demonstrated ability to initiate process improvements and take initiative.
Strong influencing skills, with the ability to work collaboratively and cross functionally, within a constantly evolving fast-paced startup environment.
Ability to drive and manage change with a positive approach.
Potential travel of up to 10%

The expected, full-time, annual base pay scale for this position is $159,000 - $199,000

Actual base pay will consider skills, experience, and location.

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Joerg Bredno

Principal Scientist, Computational Biology and Interpretation

WIDEN YOUR SCOPE

A huge data set with an even bigger impact

“Cancer is a nasty, diverse disease that can affect widely different regions in the genome,” Principal Scientist Joerg Bredno said, and understanding how and why cells change isn’t easy. Luckily, his team works with more than 12 petabytes of molecular data — which translates to more than 1 million gigabytes — and a high-performance scientific computing environment that can handle analysis at that scale. With these tools, Bredno’s team is building an even larger training data set for the next generation of GRAIL’s early detection, multi-cancer screening test, slated to roll out this year.

It is rewarding that we can see, learn and share relevant insights from our data that so far doesn't exist anywhere else in the world in this form.

Ting Ma

Associate Director, Data Engineering

ACCELERATE TOGETHER

A team united by passion, fueled by collaboration

GRAIL’s team sets lofty goals for its products, which require the unique talents and perspectives of every employee. Take one eight-month study that Associate Director Ting Ma worked on, parsing data from a GRAIL-sponsored clinical trial. Due to the volume of data, teamwork was imperative to define and implement clinical features, refine codes with robust test cases and tweak them as continuous feedback rolled in. The work is important, but that's not the only plus: “Cross-functional team collaboration is fun,” Ma said. “You get to learn so much while contributing to each project.”

GRAIL is taking on a challenge that is unprecedented. It can only become successful when people with different expertise collaborate deeply.

Ying Luan

Associate Biostatistical Director

UNCOVER NEW OPPORTUNITIES

Sharp talent, perpetually looking to learn more

There’s a reason top talent, like Associate Biostatistical Director Ying Luan, joins GRAIL. “Here, I knew I could have the opportunity to contribute to the development of innovative analysis methodologies,” Luan said. She’s now working on a diagnostic aid project, planning and designing validation for clinical studies. It’s a new area for her, but there’s plenty of support for learning new skills at the company: With resources like LinkedIn Learning, workshops and conferences, she finds footing in the field, while diversity and inclusion trainings connect her fully to GRAIL’s culture.

Post-launch activities and payer’s reimbursement were new to me when I joined GRAIL. But now, I’m learning new things on a daily basis with different stakeholders in mind.

What are GRAIL Perks + Benefits

GRAIL Benefits Overview

We’re committed to creating the best experience for everyone at GRAIL, ensuring that each member of our team has comprehensive benefits and resources to thrive at all stages of life, both at work and at home.

Culture

Volunteer in local community

Partners with nonprofits

Intermountain Healthcare

Open door policy

OKR operational model

Team based strategic planning

Open office floor plan

Employee resource groups

Employee-led culture committees

Hybrid work model

In-person all-hands meetings