Director, Veeva Clinical Ctms Lead

Pfizer Pfizer · Pharma · CT

Director, Veeva Clinical CTMS Lead at Pfizer, responsible for providing leadership and subject matter expertise in drug development processes, change management, and support for Clinical Data & Information Sciences systems. The role focuses on digitizing drug discovery and development, ensuring system data integrity and compliance with regulations, managing critical information, and driving innovation within the organization. Key responsibilities include facilitating system integration, defining strategies, leading continuous improvement programs, and interfacing with business and technical groups to gather requirements and improve processes. The role also involves serving as a subject matter expert for regulators and providing inspection readiness consultation.

What you'd actually do

  1. Provide leadership and deep subject matter expertise in the drug development processes as well as associated change management and support activities for the Clinical Data & Information Sciences, Clinical Development & Operations system portfolio.
  2. Partner with Digital & Technology and functional lines within CDO to ensure timely system(s) data integrity and compliance.
  3. Drive innovation by leading a collaborative program of continuous improvement on scalable solutions within the organization.
  4. Ensures that the company’s critical information and records stored within CD&O–owned repositories are managed in accordance with external regulations and internal processes, are protected and controlled over the long term and that data/content is available for critical business needs and is retained in accordance with established retention schedules.
  5. Lead teams of Clinical Data & Information Sciences professionals and liaise with business and technical groups to define or gather business requirements, define new business and support processes or improve existing processes.

Skills

Required

  • Bachelor's with at least 8 years of experience or MBA/MS with at least 7 years of experience or PhD/JD with at least 5 years of experience or MD/DVM with at least 4 years of experience
  • Demonstrated, basic knowledge of healthcare and/or pharmaceutical drug development environment and regulations.
  • Understanding of Clinical Trial processes such as study startup, site management, site monitoring, and operational reporting
  • Demonstrated customer relationship skills and capabilities and collaboration on teams.
  • Demonstrated ability to perform in a cross-functional environment.
  • Strong verbal, written communication and presentation skills.
  • Ability to interface with international colleagues, understand the “big picture” in terms of potential implications of changes to systems and processes to sites and/or affiliates outside of home country/region
  • Strong project management and organizational skills
  • Ability to evaluate the quality of underlying data and its potential applications
  • Exemplary relationship management skills, coupled with the ability to influence and negotiate outcomes
  • Strong analytical, problem-solving, and planning capabilities
  • Customer-oriented approach in work and solutions

Nice to have

  • Master's degree with relevant pharmaceutical industry experience.
  • Experience in leading cross-functional teams and managing large-scale projects
  • Advanced knowledge of Veeva Clinical or other Clinical Trial Management Systems (CTMS)
  • Strong understanding of regulatory requirements and compliance in the pharmaceutical industry
  • Proven track record of driving digital transformation initiatives
  • Ability to work in a fast-paced, dynamic environment and manage multiple priorities
  • Strong leadership and team management skills
  • Experience using common AI tools, including generative technologies such such as ChatGPT or Microsoft Copilot, to support problem solving and enhance

What the JD emphasized

  • external regulations and internal processes
  • regulatory requirements and compliance