Clinical Data Mgmt Director

Role Summary

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 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.

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.

Supervisory Responsibilities

• Leads colleagues in a highly matrixed organization.

Education/Experience

• BS/BA degree in related discipline and a minimum of 13 years of related experience; or,
• MS/MA degree in related discipline and a minimum of 11 years of related experience; or,
• PhD in related discipline and a minimum of 8 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 15 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 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 8 years of leading teams in a highly matrixed organization.
• Excellent understanding of clinical development, quality and regulatory standards (e.g., CDISC) and policies relevant to Data Management and risk based data management approach of clinical data (e.g., GCP, ICH).

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 moderate 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.
• Has complete understanding and wide application of technical principles, theories, concepts and techniques.
• Has strong 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

• 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.