Director, Clinical Quality & Risk Management

Summary

The position is responsible for implementation and management of system to manage quality throughout all stages of clinical trials and will report to the Vice President of Clinical Operations within the Chief Medical Officer (CMO) organization. The position supports design and implementation of efficient clinical trial protocols including tools and procedures for trial conduct (including data collection and management).

This position will act as process owner for core compliance systems supporting clinical trials, such as Quality Risk Management, Issue Management, and risk-based Oversight. The individual in this position is responsible for the state of Good Clinical Practices (GCP) Sponsor Inspection Readiness for early and late phase clinical trials. This position will conduct quarterly meetings to review trends and risks with the CMO Leadership Team members to continuously improve the system and process.

Responsibilities

• Lead development and implementation of a risk management methodology and Quality Risk Management plan for clinical studies.
• Lead and document internal risk review meetings to ensure adequate communication and management of risks to quality, working with key service providers and the internal study team members.
• Partner with Quality Assurance to ensure alignment across the organization.
• Work with Management to establish quality thresholds and indicators across all studies and incorporate into Sponsor Oversight and other plans such as Monitoring and Data Management Plans.
• Communicate risks on an as-needed basis to Management and identify areas of risk to Quality across studies and risks that are close to exceeding quality tolerance limits.
• Participate on assigned study teams as a cross-functional member, provide quality review and input during development for key clinical documents and training materials as well as QC of Clinical documents as needed.
• Provide input into clinical audit plan and support development of corrective and/or preventive actions post-audit.
• Lead Regulatory Inspection preparation activities for study teams and provide support during inspections and internal audits.
• Manage completion and execution of CAPA deliverables under the CMO organization.
• Lead CMO Center of Excellence (continuous improvement workstreams) for development and/or review of process and procedures governing the conduct of Clinical Trials.
• Partner cross functionally to support development and delivery of training specific to clinical trial conduct.
  
  

Qualifications

• BS/BA degree or clinical/science degree (e.g. RN, NP, MSN, PharmD, PhD, MD), preferably in a scientific or health related discipline.
• Minimum of 10 years of experience in the biopharmaceutical industry or at a Contract Research Organization and 5 years (Director) or 10 years (Sr. Director) combined experience working directly in a clinical quality risk management, quality assurance or GCP auditing role. Experience in these roles at a small biotechnology company is also preferred.
• Experience in hematology/oncology trials highly preferred.
• Extensive knowledge of ICH GCP and relevant global regulations and guidelines with the ability to apply the principles.
• Experience interacting with inspectors and cross-functional, global teams is required.
• Experience in working in an outsourced model for clinical trials is preferred.
• Experience developing processes, computer systems and training materials to support an effective quality management system.
• Strong project management skills and demonstrated ability to look at the big picture when making decisions and accounting for what may be in the best interest of company.
• Attention to detail with an ability to perform critical review of various types of documents.
• Ability to independently solve problems and facilitate resolution of issues.
• Demonstrated ability to work as a team player with multi-disciplinary project teams.
• Demonstrated ability to work independently but also in a team environment, exercise sound judgment, and adapt to changing work environment(s).
• Excellent verbal, written, and interpersonal communication skills (fluency in written and spoken English is a must).
• Ability to travel globally up to ~20%