Clinical Data Management Director

SUMMARY / JOB PURPOSE :

The Clinical Data Management (CDM) Director is a highly experienced and influential leader with expert knowledge of Clinical Data Management concepts and processes. This position is accountable for the operational leadership of CDM activities across all solid tumor oncology clinical studies Phase I to IV, with organizational scope in various resourcing models across geographic regions.

For the CDM Director, this position provides strategic and executional support from the Data Science & Biometrics (DSB) organization with the goal of achieving a complete and high-quality database. These positions serve as the eyes and ears of CDM / DSB, provide leadership in data completeness and quality, key contributors to the data collection and quality strategy, and provide cross-functional leadership in these areas.

This role requires a well-established CDM Lead, with a recognized track record of leading the delivery of clinical data management activities. This role has independent decision-making authority for delivery of the studies aligning to timelines and budgets set by the study teams.

ESSENTIAL DUTIES AND RESPONSIBILITIES :

• Key member of the CDM Team with accountability for delivery of all clinical trials Phase I to IV with a combination of internal FTEs (matrixed), Functional Sourcing Provider (FSP) or fully outsourced resources with a combination of on-shore and off-shore resources.
• Align with Business, Functional, and TA Heads / teams on key portfolio objectives and priorities to develop and influence the strategy and direction of CDM. Interacts with Produce Development & Medical Affairs colleagues, therapeutic or functional area leaders to execute on the organizational priorities, with a focus on quality CDM / DSB deliverables.
• Excellent organizational ability to manage CDM workload and ensure appropriate resource allocation is in place for optimal portfolio support. High level of vendor engagement / utilization.
• Decision-making has direct impact on the direction and effectiveness of the study as well as the portfolio level due to the scope and span of area of responsibility.
• Provide a leadership role in department process development and optimization of related clinical research activities. Lead or support the initiatives to drive change within CDM / BSD as well as across PDMA from a clinical data perspective.
• Align processes and priorities across the portfolio to maximize organizational effectiveness; design and implement innovative approaches to enhance productivity and effectiveness. Work with leadership to ensure the department strategy and processes are clear towards all stakeholders with optimal communication and engagement.
• Contributes to development and analysis of performance metrics and identifies ways to raise standards at the study as well as department level. Responsible for study team adherence to standards and compliance.
• Strong customer focus and belief in Exelixis values; creates a positive value-based work environment for the CDM department.

EDUCATION / EXPERIENCE / KNOWLEDGE & SKILLS :

Education / Experience :

Experience / The Ideal for Successful Entry into Job :

Knowledge / Skills :

JOB COMPLEXITY :

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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 severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $181,500 - $257,500 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.