Clinical Compliance Associate Director
Updated on 3/14/2023
Menlo Park, CA, USA
- 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%
- 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
Designs cancer screening tests
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.
- 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