Clinical Data Mgmt Director

Exelixis • Alameda, CA

92d • $181,500 - $257,500

About The Position

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.

Requirements

• 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.
• 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).

Nice To Haves

• 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).

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.
• Manage CDM workload and ensure appropriate resource allocation is in place for optimal portfolio support.
• Engage with vendors and ensure high level of vendor utilization.
• Provide leadership in department process development and optimization of related clinical research activities.
• Lead or support 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.
• Contribute to development and analysis of performance metrics and identify ways to raise standards at the study and department level.
• Ensure study team adherence to standards and compliance.
• Create a positive value-based work environment for the CDM department.

Benefits

• 401k plan with generous company contributions.
• Group medical, dental and vision coverage.
• Life and disability insurance.
• Flexible spending accounts.
• Discretionary annual bonus program.
• Opportunity to purchase company stock.
• Long-term incentives.
• 15 accrued vacation days in the first year.
• 17 paid holidays including a company-wide winter shutdown in December.
• Up to 10 sick days throughout the calendar year.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees