Associate Director, Clinical Operations Enablement & Knowledge Systems

The Opportunity:

This is a unique opportunity for a Clinical Operations Professional who has innate leadership and organizational skills, technical expertise in clinical drug development in an industry setting and a drive to promote excellence. As an Associate Director (AD) Clinical Operations Enablement & Knowledge Systems, you will be a key member of the Clinical Operations Excellence team. You will be responsible for building and scaling the Clinical Operations “knowledge ecosystem”—including how information is structured, accessed, and applied—to enable consistent, efficient, and high-quality study execution across roles and programs. This is an execution-focused role that strengthens the capabilities of the Clinical Operations organization.

• The ideal candidate is a Clinical Operations leader who combines deep study execution experience with the ability to design scalable, user-centered systems that enable others to perform at their best.

• Lead the design and deployment of a scalable Clinical Operations knowledge ecosystem, including playbooks, toolkits and structured resources that enable consistent high quality study execution.

• Develop role-based enablement frameworks aligned to Clinical Operations responsibilities, study activities, and key transition points.

• Design and deliver multi-modal learning solutions (e.g., live sessions, on-demand modules, short-form videos, playbooks, and interactive resources) to maximize accessibility and adoption.

• Apply adult learning principles and user-centered design to ensure content is practical, engaging, and immediately applicable.

• Apply knowledge of Clinical Operations workflows and regulatory context (e.g., GCP, ICH) to ensure learning content is relevant, practical, and aligned with real-world study execution (this role does not own SOP development, GxP training, or inspection readiness activities).

• Support the successful onboarding of new Clinical Operations team members.

• Design and deliver targeted, “just-in-time” learning tools and experiences (e.g., checklists, quick guides, decision aids) to support critical activities and study milestones.

• Align learning and knowledge resources to key study lifecycle stages (e.g., study start-up, conduct, database lock, close-out).

• Define and implement a scalable structure for Clinical Operations knowledge, including how resources, tools, and guidance is organized, accessed, and maintained.

• Create intuitive, role-based pathways for accessing information across study lifecycle stages.

• Establish standards for maintaining and continuously improving operational knowledge.

• Own day-to-day planning, coordination, and delivery of learning activities, ensuring timeline, quality and outcomes are met.

• Track adoption, effectiveness and impact of learning and knowledge initiatives.

• Use feedback and performance insights to identify capability gaps and continuously improve tools, resources, and learning solutions.

• Evolve learning materials and resources to maintain alignment with Clinical Operations and cross-functional partner growth and needs.

• Partner with Clinical Operations and cross-functional team members to improve processes that will impact clinical trial management, quality and efficiency.

• Line management responsibilities including hiring, performance management, career development, and mentorship.

• This role does not own SOP authoring, GxP training delivery, or inspection readiness activities, but partners with relevant functions to ensure alignment.

• Participate in other Clinical Operations Excellence and Clinical Operations Activities as appropriate.

Required Skills, Experience and Education:

• RN or Bachelor’s degree in biological sciences or health-related field required.

• 11+ years direct Clinical Operations experience in the pharmaceutical or biotech industry, Relevant indirect experiences may also meet the requirement.

• Minimum of 5 years of line management experience.

• Strong working knowledge of FDA Regulations, ICH Guidelines, and GCP.

• Demonstrated experience successfully developing and authoring Clinical Operations and cross-functional handbooks, guidances or process templates in support of clinical operations or clinical study team management.

• Experience with leading organizational change efforts.

• Minimum of 6 years of cross-functional study management or related leadership experience in life sciences.

• Demonstrated experience building or scaling learning programs, knowledge systems, or operational frameworks within Clinical Operations.

• Experience translating complex clinical workflows into practical tools, guidance, or training materials.

• Strong systems thinking and ability to design scalable, user-friendly solutions.

• Experience in selection and management of external resources (e.g., CROs, vendors, contractors).

• Thrives in a collaborative team setting that demonstrates flexibility required to maintain a fast pace and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.

• Be solution-oriented by anticipating obstacles and difficulties, and proactively providing risk assessment and mitigation strategies to achieve project goals.

• Ability to deal with time demands, incomplete information, or unexpected events.

• Outstanding organizational skills with the ability to multi-task and prioritize.

• Excellent interpersonal, verbal and written communication skills.

• High sense of priority and commitment to excellence in the successful execution of deliverables.

• Ability to contribute with a mind on quality, diligence, timeliness and fiscal responsibility, make and drive decisions, multi-task, prioritize tasks, anticipate challenges, and execute on goals as a member of the Clinical Operations Excellence team.

• Decision-making skills.

• Comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities.

• Demonstrate proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus.

• Travel may be required (~25%).

Preferred Skills:

• Experience deploying AI-enabled solutions to support Clinical Operations activities.

• Familiarity working with in-house or vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS).

• Oncology experience, early and/or late stage, strongly preferred.

• Experience in start-up, management, and close-out of clinical trials, including authoring clinical study and regulatory documentation.

• Knowledge and/or familiarity with Ex-US region(s) clinical trial operations. 

  #LI-Hybrid  #LI-DN1