Vice President, Clinical Data Management

SUMMARY/JOB PURPOSE:

Responsible for developing and executing the strategy for Clinical Data Management. This includes but not limited to the department structure, data management strategy and standard workflows, clinical data standards and supporting data technology solutions, policies and procedures, and talent/resource management that lead to high-quality data in a compliant and consistent manner across Exelixis. Ensures compliance and leadership for the department and promotes and leads standardization, innovation and builds a high performing team Provides leadership and professional development support for Data Management staff.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Develop Vision and  Strategy for Clinical Data Management.
• Provide day-to-day leadership/coaching of the Clinical Data Management group to ensure implementation and accountability of the data strategy at trial and program-level to support Early Clinical Development through Late-Stage Development by ensuring that Data Management processes, standards, templates, and best practices are applied fit for purpose to meet trial/program needs.
• Drive overall data strategy and standards to ensure both clinical and operational data is handled consistently from start-up through database lock, ensuring development of processes and standards, e.g., standard data collection, data transfer specifications, eCRFs, and site instructions, Data Management Plan, and other clinical data review standards. Provides expertise and guidance to relevant stakeholders regarding CDISC data standards.
• Participate in the Executive Steering Committee (ESC) and/or Project Operational Committee of relevant vendors, including but not limited to Data Management Vendor(s), Sample management verdors, ensuring successful vendor deliverables and relationships at the program/portfolio level.
• Ensure an end-to-end mapping across all data management activities, not limited to project management, external data transfers/integration and reconciliation, medical coding, clinical standards and eCRF development, Data review plans, Data quality matrices, maintenance, and appropriately ensure validation of clinical data systems and data repositories.
• Lead data standardization initiatives to ensure protocols comply with portfolio-level standards, CDISC standards, SOPs, and regulatory requirements.
• Lead the development, review, implementation, and improvements of departmental processes, policies, standard operating procedures, training, and work guidance.
• Develop and implement a continuous process improvement strategy by monitoring key performance indicators, metrics, quality and trial/program level deliverables, and timelines.
• Maintain oversight of record retention strategies within the data management area in accordance with SOPs and all applicable global regulations, ensuring an adequate level of documentation and storage, e.g., eTMF, data repositories, etc.
• Drive the development of data management outsourcing strategies and long-term relationships with internal stakeholders, e.g., Contract Management, Vendor Management, etc., including the definition of the scope of projects and contract negotiation with external vendors that include cost, schedule, and performance expectations.
• Effectively manage department resources to support a rich pipeline of complex trials/programs.
• Ensure effective quality oversight and management of vendors/external partners performing data management services on behalf of Exelixis by monitoring key performance indicators, metrics, quality and trial/program level deliverables, and timelines.
• Drive improvement initiatives internally and with vendors based on lessons learned, metrics, audit reports, and input from project team members and other stakeholders.
• Oversee systems within the data management area not limited to EDC, IRT, data review tools, ePRO/eCOA in relation to implementation, validation, audit trail, access controls, system oversight, etc.
• Oversee development of standards tools related to data cleaning activities, data listings, data report generation e.g., error detection, missing data, etc. to ensure standard processes and reports are generated across trials.
• Effectively interact with other functional area leaders to support the overall operational and strategic activities for trial execution.
• Proactively identify and troubleshoot operational problems, issues, and obstacles, and help trial/project teams to remove barriers. Builds and leads a team of high performing clinical data managers to meet regulatory, scientific, and business objectives.
• Provide ongoing feedback, coaching and career development to support and maximize staff potential. Develop and coordinates training for data management staff.
• Provide data management representation and expertise on internal cross-functional teams, external partnership collaborations and for executive leadership team.
• Provide strategic and tactical guidance in risk management of clinical trial execution; develop and execute risk mitigation plans for Data Management deliverables.
• Lead the development of project budgets; proactively manages study budgets, including accurate forecasting and cost accruals.
• Support project/trial teams during submission, inspection, and other regulatory-related activities, including, but not limited to, developing oversight processes, creating storyboards, presenting issues and mitigations.
• At the trial or project level, proactively drive quality, efficiency, and innovation to ensure data management deliverables are met within the established timelines, budget, and quality/compliance standards (e.g., provide input to protocol design, database design, and validation, and data management plans, including data review strategies and data quality assurance, plans to ensure alignment with planned analysis and reporting objectives.)
• May perform day-to-day tactical responsibilities to ensure successful execution of clinical trials.

SUPERVISORY RESPONSIBILITIES:

• Directly supervises employees.
• May Indirectly supervise employee (s) through a dotted line structure or via other subordinate supervisors.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• BS/BA degree in related discipline and a minimum of 21 years of related experience; or,
• MS/MA degree in related discipline and a minimum of 19 years of related experience; or,
• PhD in related discipline and a minimum of 17 years of related experience; or,
• Equivalent combination of education and experience.
• May require certification in assigned area.

Experience/The Ideal for Successful Entry into Job:

• Typically requires a minimum of 22 years of related experience and/or combination of experience and education/training.
• Experience in Biotech/Pharmaceutical industry preferred.
• Experience in Oncology clinical trials is preferred.
• Experience leading major change initiatives is preferred.
• Demonstrated experience leading data management teams is required.
• Experience participating in regulatory submissions and inspections is required.
• A minimum of 14 years of line management experience is required.

Knowledge/Skills:

• Has extensive experience in relevant industry/profession.
• 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.
• Leads or manages the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for 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 of Clinical Research Organizations (CROs).

JOB COMPLEXITY:

WORKING CONDITIONS:

• Environment: primarily working indoors, performing clerical work

#LI-JD1

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

Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $331,000 - $384,500 annually. The base pay range may take into account the candidate’s geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate’s geographic region, job-related knowledge, skills, experience and internal equity, among other factors.

In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.

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.