Clinical Compliance Associate Director

Companion Diagnostics

Updated on 3/14/2023

Locations

Menlo Park, CA, USA

Experience Level

Entry

Junior

Mid

Senior

Expert

Requirements

B.S./B.A. in a science or related life science field; advanced scientific degree preferred
8+ years experience in clinical trial activities in any of the following industries: pharma/biotech (preferred), in vitro diagnostic, medical device
Expert knowledge of FDA, ICH principles and Regulatory guidance as they relate to clinical trial conduct and the operations of laboratories that process clinical trial samples
Strong understanding of appropriate global medical device/IVD requirements and pharmaceutical product requirements, such as: ICH E6 (GCP), European Union (ISO 20916, ISO 14155, ISO13485:2016, ISO14971, IVDD/IVDR), US [21 CFR Parts 11, 50, 56, 312 and 812], etc
Significant experience managing quality activities such as conducting internal process and clinical laboratory audits, hosting or supporting regulatory inspections, managing CAPAs, etc
Demonstrated ability to initiate process improvement and take initiativeStrong influencing skills, with the ability to work collaboratively and cross functionally, within a constantly evolving, fast-paced, fast-growing startup environment
Ability to drive, manage, and adapt to change with a positive approach
Potential travel of up to 10%

Responsibilities

Prepare cross-functional departments (Clinical Laboratory, Clinical Operations, Clinical Data Management, Biostatistics, Medical Directors, Bioinformatics, Software, and IT) for the expectations of both our biopharmaceutical partners and regulatory authorities for the conduct of clinical trials
Prepare for GCP audits by partners and inspections by regulatory authorities, assist in the hosting of these activities, respond to audit findings and provide lessons learned
Participate in internal audits of systems, processes, and departments supporting the PDx program
Attend team meetings, provide compliance counseling
Provide compliance oversight of revisions to or creation of new clinical trial related SOPs and other Quality Management System documents to include changes in international law, regulation, policy or standards
Act as the point of contact for the partners' Clinical Quality Assurance organizations

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.

Grail’s Clinical Compliance department is seeking a clinical compliance expert to support Grail’s partnerships with biopharmaceutical companies for companion diagnostic (CDx) tests. The Associate Director of Clinical Compliance will work cross functionally to help ensure that the clinical trials supporting the CDx programs, in collaboration with biopharmaceutical companies, are conducted in accordance with Good Clinical Practice (GCP) standards and regulatory requirements.

You will lead all Clinical Compliance activities for all CDx programs, including:

Prepare cross-functional departments (Clinical Laboratory, Clinical Operations, Clinical Data Management, Biostatistics, Medical Directors, Bioinformatics, Software, and IT) for the expectations of both our biopharmaceutical partners and regulatory authorities for the conduct of clinical trials
Prepare for GCP audits by partners and inspections by regulatory authorities, assist in the hosting of these activities, respond to audit findings and provide lessons learned.
Participate in internal audits of systems, processes, and departments supporting the PDx program
Attend team meetings, provide compliance counseling
Provide compliance oversight of revisions to or creation of new clinical trial related SOPs and other Quality Management System documents to include changes in international law, regulation, policy or standards
Act as the point of contact for the partners’ Clinical Quality Assurance organizations

To be successful in this role you will have:

B.S./B.A. in a science or related life science field; advanced scientific degree preferred.
8+ years experience in clinical trial activities in any of the following industries: pharma/biotech (preferred), in vitro diagnostic, medical device
Expert knowledge of FDA, ICH principles and Regulatory guidance as they relate to clinical trial conduct and the operations of laboratories that process clinical trial samples
Strong understanding of appropriate global medical device/IVD requirements and pharmaceutical product requirements, such as: ICH E6 (GCP), European Union (ISO 20916, ISO 14155, ISO13485:2016, ISO14971, IVDD/IVDR), US [21 CFR Parts 11, 50, 56, 312 and 812], etc.
Significant experience managing quality activities such as conducting internal process and clinical laboratory audits, hosting or supporting regulatory inspections, managing CAPAs, etc.
Demonstrated ability to initiate process improvement and take initiativeStrong influencing skills, with the ability to work collaboratively and cross functionally, within a constantly evolving, fast-paced, fast-growing startup environment
Ability to drive, manage, and adapt to change with a positive approach
Potential travel of up to 10%

The expected, full-time, annual base pay scale for this position is $154,000 - $205,000. Actual base pay will consider skills, experience, and location.

Based on the role, colleagues may be eligible to participate in an annual bonus plan tied to company and individual performance, or an incentive plan. We also offer a long-term incentive plan to align company and colleague success over time.

In addition, GRAIL offers a progressive benefit package, including flexible time-off, a 401k with a company match, and alongside our medical, dental, vision plans, carefully selected mindfulness offerings.

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. GRAIL maintains a drug-free workplace.

Following extensive monitoring, consideration of business implications, and advice from internal and external experts, GRAIL US has made the decision to require that all U.S. employees be “Fully Vaccinated” with the COVID-19 vaccine. “Fully Vaccinated” is defined as two weeks after both doses of a two-dose vaccine (e.g. Pfizer or Moderna) or two weeks since a single-dose vaccine (e.g. Johnson & Johnson) has been administered. Absent a qualifying exemption, all GRAIL US employees are to comply with this requirement, including providing documentation of such vaccination status, as a condition of employment. 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 for consideration by GRAIL.

501-1,000 employees

Website

Designs cancer screening tests

Company Overview

GRAIL's mission is to detect cancer early, when it can be cured. They are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care.

Benefits

Outstanding People - Join a team of passionate and dedicated professionals, committed to collaboration, education, and proactive problem-solving.
Strong Compensation - We offer competitive salaries and savings plans to provide for long-term financial planning.
Complete Health Coverage - Take advantage of comprehensive health coverage, with medical, dental and vision, to keep you and your family healthy.
Work-Life Balance - Make everyday life more manageable with flexible time off – we trust you to do great work and take time for yourself.

Company Core Values

Grit - We are determined and resilient because patients are counting on us.
Respect - We value diversity and challenge each other respectfully.
Accountability - We own our decisions and keep our commitments.
Integrity - We adhere to our principles of humility, transparency, and rigor.
Leadership - We make each other better by making leadership everyone’s responsibility