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Associate Clinical Programming Director
Associate Clinical Programming DirectorExelixis • Alameda, CA, US
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Associate Clinical Programming Director

Associate Clinical Programming Director

Exelixis • Alameda, CA, US
[job_card.30_days_ago]
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  • [job_card.full_time]
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Associate Clinical Programming Director

As a member of the Digital Strategy, Analytics, and Programming Leadership Team, this role guides and influences the strategic direction and priorities of the function and partners closely with the Research & Development organization. The Associate Clinical Programming Director develops outputs and listings that support the Data Management and Clinical Operations team in reviewing and addressing data issues. The Associate Clinical Programming Director sponsors and ensures the on-time delivery of pivotal initiatives that involve significant business, technical, and process improvements across the organization.

Essential Duties / Responsibilities :

  • Prepare / update specifications per the Data Manager / Clinical Operations requirement to identify data issues.
  • Knowledge and experience in creating Clinical programming reports such as EDC listings, Edit check reports, Coding review reports on AEs and concomitant medication data, Data review listings, Patient profiles, Lab / vendor and Serious AE reconciliations, Special character listings, protocol deviation listings, Patient Narratives, and CRF metric reports.
  • Communicate with the Data Manager and Clinical Operations lead on data issues.
  • Develop standard macros and utilities to reduce repeated tasks or to implement automation.
  • Build strong relationships with partners, influence and collaborate effectively across PDMA and Research organizations.
  • Balance internal and external expertise to secure the availability of the right people at the right time to support the development of the Exelixis pipeline.
  • Strategic leadership in developing and maintaining data delivery models / options, balancing customer needs and efficiency, and being an interface for internal or external partners.
  • Drive an environment of global standardization, continuous improvement, and productivity gains.
  • Drive innovation to update and deliver new capabilities, including capability builds and rollout.
  • Develop, coach, mentor, motivate, and inspire individuals within the organization and attract, recruit & retain top talent.
  • Strategic workforce planning and capability building for current and emerging needs within CP.
  • Lead or participate in critical initiatives as needed, partnering with functional leaders across the business to ensure high-quality contributions and readiness for implementation. The initiative's scope should significantly impact the Clinical Operations organization, TA, or R&D.
  • Participate in industry forums to drive and shape future ways of working.
  • Deliver agreed departmental activities within the budgeted target.
  • Ensure compliance with ethics, policies, and standard procedures.

Education / Experience / Knowledge & Skills :

Education :

  • Bachelor's degree in Biological Sciences, Data in a related field (e.g., Computer Science, Biology, life science) or equivalent and a minimum of 11 years related experience; or,
  • Master's degree in Biological Sciences, Data in a related field (e.g., Computer Science, Biology, life science) or equivalent and a minimum of 9 years of related experience; or,
  • Equivalent combination of education and experience.
  • Knowledge, Skills and Abilities :

  • Strong technical expertise in platforms like SAS, R, Python, Spotfire, and Tableau.
  • Knowledge and enterprise experience leading data acquisition, analytics, and AI-based capabilities across multiple Clinical domains.
  • Experience implementing business processes and managing functional budgets.
  • Problem-solving ability to resolve conflict and deal with a wide range of complex problems independently and through others.
  • Innovative mindset, ability to think beyond traditional working methods, influence and inspire change.
  • Highly developed analytical skills, conceptual thinking, and integrative vision required to drive customer needs, business performance, and risk management.
  • Strong ability to explain technical concepts to non-technical members of the organization.
  • Thorough knowledge of clinical development process, industry standards, and resources needed to manage trials of differing complexities.
  • Tried ability to influence relevant stakeholders and global teams.
  • Proven experience of successfully leading global teams.
  • Extensive experience working successfully with external partners at senior levels in their respective organizations.
  • Leads change with a positive approach for the self, team, and the business. Sees change as an opportunity to improve performance and contribute to the business.
  • Demonstrated global and inclusive line management, development, and mentorship of others, identifying and providing opportunities to improve other people's capabilities.
  • Demonstrated ability to set and handle priorities, resources, performance targets, and project initiatives in a global environment.
  • Work Environment / Physical Demands :

  • Environment : primarily working indoors on a computer in an office setting.
  • Travel up to 10%
  • Our office is a modern, open-plan space that fosters collaborations and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.

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    Associate Director Clinical • Alameda, CA, US

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