Senior Clinical Data Management (CDM) Director

Summary/Job Purpose

The Senior 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 clinical studies Phase I to IV, with organizational scope in various resourcing models across geographic regions. For the Senior 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. This position serves as the eyes and ears of CDM/DSB, provides leadership in data completeness and quality, key contributors to the data collection and quality strategy, and provides 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.
• Interact 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.
• Contribute 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.

Supervisory Responsibilities

Lead colleagues in a highly matrixed organization.

Education/Experience

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS

• 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.
• May require certification in assigned area.

Experience/The Ideal For Successful Entry Into Job

• 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 preferred.
• Demonstrated experience leading global data management activities is required.
• Experience participating in regulatory submissions and inspections is required.
• A minimum of 10 years of managing teams in a