Senior Clinical Data Management Process Director

SUMMARY/JOB PURPOSE (Basic purpose of the job):

The Senior Clinical Data Management Process Director is a highly experienced and influential leader with expert knowledge of CDM concepts and processes. This position is accountable for the effectiveness of all CDM processes, policies, and procedures, and driving the consistent understanding across the CDM organization to ensure timely and high quality execution of work across all clinical studies Phase I to IV.

This role requires a well-established leader, with a proven track record of building and maintaining sustainable CDM working practices that are compliant with all global regulatory and industry standards, and with an ability to effectively design enhanced ways of working, through thought leadership and high levels of collaboration across R&D functions.

This role will also include other responsibilities with decision-making authority on behalf of the CDM organization, e.g. building and maintaining external vendor oversight framework, departmental budget, change management and communications strategy.

This incumbent must be capable of representing Clinical Data Management (CDM) and Data Science & Biometrics (DSB) in a leadership capacity. The role requires strong partnership and close collaboration with senior functional and matrix leaders across the R&D organization to ensure the successful, efficient, high quality, and compliant work delivery supporting the company portfolio.

ESSENTIAL DUTIES/RESPONSIBILITIES:

• Responsible for the defining, and driving, the vision for optimized CDM processes, policies and procedures that are compliant with global regulatory requirements and guidances, company policies and procedures, aligned with industry standards, and result in timely high quality clinical data management delivery.
• Ownership of all CDM Standard Operating Procedures (SOPs), Work Instructions (Wis), Forms, and Templates, as well as the engagement of a Subject Matter Expert (SME) network within the CDM organization supporting development and maintenance of best practices.
• Ensure end-to-end management of all CDM working practices by proactively defining and implementing performance measures (quality, time, cost), and engaging across CDM, DSB, and other R&D functions to ensure ongoing enterprise mindset in defining CDM and broader approaches to effective and optimal CDM work delivery.
• Establish, and maintain, governance structures working with relevant vendors including, but not limited to, data management vendor(s), sample management vendor(s), to ensure effective quality oversight of vendor deliverables and relationships supporting the company portfolio.
• Lead initiatives to ensure data management methods continuously comply with regulatory requirements, industry standards (e.g. CDISC), company policies and procedures, portfolio-level standards, and the practical needs of individuals studies.
• Coordinate ongoing training of the CDM organization as global regulatory, industry, and company standards evolve.
• Work across the CDM organization to ensure timely proactive identification of quality issues, subsequent root cause analysis, definition of appropriate corrective/preventative actions, and effectiveness checks, to mitigate future risk of reoccurrence.
• Serve as the primary CDM contact for audit and inspection preparation/conduct, effectively collaborating with Quality Assurance and R&D business functions focused on quality and integrity of CDM data and documentation deliverables.
• Support study teams during submission, inspection, and other regulatory-related activities including, but not limited to, developing oversight processes, creating storyboards, presenting issues and mitigations.
• Drives cross-functional senior leadership engagement to develop and deliver solutions for new service capabilities.
• Contribute to the development of departmental and study budgets, proactively managing budget, including accurate forecasting and cost accruals.
• Strong customer focus and belief in Exelixis values; creating a positive value-based work environment for the CDM organization. Able to inspire and influence team/organization through rapidly changing business challenges.
• Stay current with regulatory and industry advances through cultivation of a wide external network. Able to represent Exelixis in data management, data strategy and other related capacities. Helps establish and maintain Exelixis CDM as an industry leader.
• May perform day-to-day tactical responsibilities to ensure successful execution of clinical studies across the company portfolio.

SUPERVISORY RESPONSIBILITIES:

• Individual contributor role.
• Indirect responsibility for quality work delivery of staff through engagement of SMEs, training and development on company policies and procedures.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education:

• BS/BA degree in related discipline and a minimum of 15 years of related experience; or,
• MS/MA degree in related discipline and a minimum of 13 years of related experience; or,
• PhD in related discipline and a minimum of 12 years of related experience; or,
• Equivalent combination of education and experience.
• Lean Six Sigma certification is preferred.

Experience:

• Typically requires a minimum of 17 years of related experience and/or combination of experience and education/training.
• Experience in Biotech/Pharmaceutical industry required.
• Experience in Oncology clinical trials is preferred.
• Experience leading major change initiatives is required.
• Experience participating in regulatory submissions and inspections is required.

Knowledge, Skills and Abilities:

• Has extensive experience in relevant industry/profession.
• Excellent understanding of clinical development, quality and regulatory standards (e.g. CDISC) and policies relevant to data management (e.g. GCP, ICH).
• Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.
• Develops technical and/or business solutions to complex problems.
• Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results.
• Guides the successful completion of major programs, projects and/or functions.
• Strong ability to effectively influence the work of others by providing guidance to individuals and teams based on organizational goals and company policy, to ensure results, including costs, methods and staffing.
• Interprets, executes and recommends modifications to companywide policies and/or divisional programs. May establish organizational policies in a major segment of the company.
• Has complete understanding and wide application of technical principles, theories, concepts and techniques.
• Has extensive knowledge of other related disciplines.
• Applies strong analytical and business communication skills.
• Ability to identify, author, maintain and train staff on key data management SOPs and work-practice guidelines.
• Knowledge of Good Clinical Practices (GCP) is essential.
• Demonstrated success managing data management activities performed by external vendors.
• Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles.
• Exercises independent judgment in methods, techniques, and evaluation of criteria for obtaining results.
• Creates formal networks involving coordination among groups.
• Environment: primarily working indoors.

Work Environment/Physical Demands:

Our office is a modern, open-plan space that foster collaborations and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.

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If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!

DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.