Sr Director, Clinical Solutions & Compliance

GENERAL SUMMARY:  

The Senior Director of Clinical Solutions & Compliance is accountable for defining the vision, mission and strategy for the function, which resides in the Clinical Operations organization.  This position has responsibility for overseeing clinical systems, training programs and implementing appropriate processes and procedures to ensure GCP compliance and inspection readiness within Clinical Operations. The Sr. Director will also sponsor and/or lead key strategic Clinical Operations organizational initiatives.  This position will also be responsible for people/team management and mentoring of indirect and direct reports. 

Essential Duties & Responsibilities: 

Responsibilities:   

• Build and lead the Clinical Solutions & Compliance team to create, deploy and manage Clinical Operations’ systems, process and procedures, training programs, GCP compliance and regulatory inspection activities.  
• Oversee the development and deployment of Clinical Operations’ Policies, Quality Standards and Standard Operating Procedures in accordance with ICH/GCP regulations and company policies to ensure inspection readiness. 
• Drive the implementation of a proactive, risk-based approach to Quality into Clinical Operations systems and processes by integrating principles of Risk Management per ICH E6/E8. 
• Support the design and implementation of Clinical Operations’ Sponsor Oversight framework, ensuring high-risk outsourced activities are meeting 4DMT performance standards. 
• Ensure optimal relationships with key internal stakeholders, as well as vendors, to enable the successful development and deployment of Clinical Operations and cross-functional Development processes, clinical systems, quality documentation and training programs, as appropriate. 
• Partner with Clinical Quality Assurance to oversee Inspection Preparation initiatives and support GCP regulatory authority inspections. 
• Provide oversight and strategic guidance for key clinical systems, such as eTMF, CTMS and IWRS, ensuring systems development strategies protect the integrity of GCP records and data. 
• Actively participate as a member of the Clinical Operations Leadership Team in the development of organizational goals and strategies. 
• Lead key strategic Clinical Operations organizational initiatives by translating the vision into actionable strategies and ensuring that plans are executed per commitments.  Includes the identification of process challenges, process enhancement, and training of teams. 
• Accountable for the line management of Clinical Solutions & Compliance staff, including development, coaching, talent planning and performance management.   
• Provide input to and rationale for department budget and maintain control of functional expenditures against department budget. 
• Develop and present strategic and operational plans to senior management. 

Core Competencies, Knowledge and Skill Requirements: 

• Ideal candidate will have demonstrated ability in the following areas: GCP regulatory authority inspections, process development & improvement, training & development, development of a clinical compliance function, and clinical systems 
• Experience developing and leading a clinical risk management function/process and the ability to demonstrate an understanding of a clinical quality management system 
• Previous experience in managing a group or business unit, including the management of budgets, timelines and resources 
• Strong working knowledge and interpretation of FDA/EU and ICH – GCP regulations and guidelines 
• Broad and direct experience with regulatory authority inspections, including both FDA and EMA inspections 
• Strong strategic planning and decision-making skills 
• Proven ability to convey clear direction and accountabilities to team and delegate work that empowers ownership 
• Deals comfortably with uncertainty of change and effectively handles risks with ability to be flexible and adaptable to changing business needs 
• Must have the ability to build and maintain positive relationships with senior management, peers, and direct reports  
• Focused on practical, commonsense and sensible approaches to finding effective solutions with a focus on embedding strong quality and compliance behaviors 
• Willingness to work in a dynamic and changing corporate environment 
• Previous experience leading key strategic functional initiatives 
• Excellent written and verbal skills required.  Must display strong analytical and problem solving skills   
• Willing to travel domestically and internationally, as needed 

Communication & Interpersonal Skills: 

• Excellent communication and interpersonal skills 
• Must be able to write clearly and summarize information effectively 
• Must be able to present complex information to various audiences 

Requirements: 

• Bachelor degree or equivalent required  

• 15+ years of experience of applicable industry experience in drug development across both early (Phase 1 or 2) and late-stage (Phase 3) clinical development 
• minimum of 6+ years managerial experience 

 Bay Area Salary Range:

$234,000/yr - $295,000/yr

National Range: 

$212,000/yr - $268,000/yr