Job Description The Executive Director, Quality & Compliance – Clinical Trials will serve as a member of the CTS Medical Affairs leadership team, a strategic partner to the Recruitment, RWE and Trial Delivery business lines, and a supporting partner to all CTS functions and stakeholders involved in clinical research.
The Executive Director is a leadership role with substantial strategic input as serves as the lead Quality officer within CTS. This role will be responsible for defining the strategy and tactics required to support CTS in Quality Management Systems (QMS), Compliance, and Training. The role will be responsible for interacting with cross-functional teams externally and internally, including clinical operations, business development, enterprise analytics, clinical data management
They will establish comprehensive quality processes and systems that support collaboration and compliance across an extended partner network and develop, implements and communicates a clear strategic vision for quality to maximize employee focus, while maintaining a strong independent role for compliance-related decisions.
The incumbent will review existing policies and procedures, identifies gaps, and supports the development and communication of new and enhanced policies and procedures leading to compliant operations. As well as provide overall leadership for the Quality and Compliance function to establish compliant processes and systems that support collaboration
The Executive Director will assure personnel, processes, documentation, and quality standards meet expectations for BioPharma sponsors and patterns while maintaining compliance with applicable regulations and guidelines. They will formulate quality and compliance policies in coordination with corporate management and ensures that all required systems and standard operating procedures are in place and current
Key responsibilities: • Ensure monitoring and auditing of CVS Clinical Trial Services operations to identify potential compliance risk areas; recommends and assists with the implementation of enhancements to existing policies and procedures and other corrective actions • Foster an environment of collaboration, trust, quality, innovation and continuous improvement within the Quality organization and between other functional departments • Identify and assess Clinical Trial Services quality risks and ensures they are evaluated and managed appropriately in order to accomplish both business goals and regulatory and quality requirements • Identify emerging trends/changes and redesign processes and practices accordingly • Oversee audits of sites, documents, databases, vendors or internal systems in compliance with GCP and CVSH/CTS policies and procedures. Assess impact of audit findings and other identified compliance risks to subject safety, data integrity, and business operations and escalate compliance risks to CTS management. Ensure audit reports and corrective actions are developed and completed within timelines mandated in internal procedures • Lead Trial Delivery/RWE/Recruitment operations teams in preparation for announced inspections and provide GCP compliance technical support during inspections of trial sites. Facilitate appropriate and timely inspection responses and follow-up actions. Assess and improve our overall processes and systems for utilizing therapeutics in clinical trials • Oversee design and develop of instructional materials for a variety of delivery methods including, e-learning, virtual classroom, web-based, podcast, and reference guides. Supervise a staff of training and development specialists, such as instructional designers, program developers, and instructors. • Collaborate with product teams; sponsors, thought leaders, regulatory bodies (FDA and other), and strategic partners to add to the growing body of knowledge around quality and compliance in DCTs, RWE, etc
Pay Range The typical pay range for this role is: Minimum: 131,500 Maximum: 297,250
Please keep in mind that this range represents the pay range for all positions in the job grade within which this position falls. The actual salary offer will take into account a wide range of factors, including location.
Knowledge of: • Global Health Authority regulations and guidance • Patient privacy regulations • Data standards and integrity • Clinical research concepts, practices, and regulations • Trial design and protocol development • Industry Best Practices • Government grants and contracts • Health economic and outcomes research • Market access • Registry programs
Skill In: • Risk assessment and mitigations • Influencing and Collaboration • Leadership • Strategy development • Developing and disseminating novel best practices
Ability To: • Identify and conduct process improvement • Identify and communicate critical issues • Take complex regulatory information and communicate it clearly and effectively to diverse audiences in a clear and concise manner • Flex and thrive in an ambiguous environment undergoing transformational change. • Represent the company in sales/partnership opportunities, external speaking opportunities, and media and advocacy engagements
Preferred Qualifications • Advanced Degree
Education • Bachelor’s Degree
Required Qualifications The successful candidate will have a strong work ethic, be a self-starter, and able to be highly productive in a dynamic, collaborative environment. This position offers broad exposure to all aspects of the company’s business, as well as significant interaction with senior business leaders.
• 10+ years’ experience in Biopharma, CRO, site network or AMC working in Clinical Research • 8+ years’ experience in ICH GCP, drug and applicable FDA regulations and guidance for clinical development including advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to safety and data integrity. • 5+ years of leadership experience across quality, compliance or clinical operations • Strong track record of quality and process improvement • Excellent leadership and interpersonal skills; should have proven skills as an effective team player who can engender credibility and confidence within and outside the company; must have ability to interface with customers. • Ability and strong desire to be “hands on”. Posse’s a results-oriented work ethic and be a critical thinker for problem solving.
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