Associate Director, Clinical Data Management
Associate Director, Clinical Data Management
Every Exelixis employee is united in an ambitious cause: to launch innovative medicines that give patients and their families hope for the future. In this pursuit, we know our employees are our most valuable asset. After operating in the challenging biotech sector for 25 years, we have a proven track record of resiliency in the face of adversity. The success of our lead product has provided a solid commercial foundation allowing us to reinvigorate our research efforts, and grow our team in areas such as Drug Discovery, Clinical Development and Commercial.
As we expand our global partnerships and further reinvest in R&D to help us discover the next breakthrough for difficult-to-treat cancers, we’re seeking to add talented, dedicated employees to power our mission.
Cancer is our cause. Make it yours, too.
Oversees, develops and manages clinical data management activities while collaborating and coordinating with other departments. Oversees the evaluation, integration and implementation of new clinical systems and technologies for clinical trial management activities including electronic data capture and documentation systems.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Provides a high level of expertise in data management to support clinical studies, including areas such as: Case Report Form (CRF) design, database design, data management plans, edit checks/quality review plans, query resolution processes, data transfers, SAE/AE reconciliation, thesaurus coding processes, and database lock.
• Manages time and resource constraints across multiple projects.
• Develops and implement new or improved processes for data management.
• Effectively manages Clinical Research Organizations (CROs) to ensure high-quality deliverables within timeline and budget.
• Participates in development of Request For Proposals (RFPs) and evaluation of vendors, products and proposals.
• Provides oversight on quality and timeliness of task completion by direct reports.
• Develops and implement training curriculum for data management activities and principles as required.
• Directly supervises employees
• May indirectly supervise employee (s) through a dotted line structure or via other subordinate supervisors.
• BS/BA degree in related discipline and 13 years of related experience; or,
• MS/MA degree in related discipline and 11 years of related experience; or,
• PhD in related discipline and 8 years of related experience, or;
• Equivalent combination of education and experience.
• May require certification in assigned area.
• Typically requires a minimum of 14 years of related experience and/or combination of experience and education/training.
• Experience in Biotech/Pharmaceutical industry preferred.
• Demonstrated experience leading data management teams is required.
• Experience participating in regulatory submissions and inspections is required
• A minimum of 7 years of line management experience is required
• 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).
• Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles.
• If in a leadership role, works on complex issues where analysis of situations or data requires an in-depth knowledge of the company.
• Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results.
• If in a leadership role, participates in corporate development of methods, techniques and evaluation criteria for projects, programs and people.
• Ensures budgets and schedules meet corporate requirements.
• Creates formal networks involving coordination among groups. Regularly interacts with executives and/or major customers.