Development Transformation Lead, Director

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Requirements:

• 10+ years of experience in clinical development, clinical operations, or clinical quality assurance within pharmaceutical, biotech, or CRO environments.
• Demonstrated experience leading large-scale process transformation and change management in a regulated (GxP) environment.
• Strong knowledge of controlled document management frameworks, strategies and inspection readiness principles.
• Proven ability to lead cross-functional initiatives, manage complexity, and influence across a matrixed organization.
• Experienced in vendor operational oversight and working with external experts to bring in industry best practices.
• Comfortable with ambiguity and building frameworks from the ground up; strong strategic and analytical thinking and problem-solving skills with demonstrated ability to bring structure to vaguely defined problems.
• Excellent written and verbal communication skills; effective at stakeholder engagement with solid ability to drive decisions and change management.
• Familiarity with Quality Management System (QMS) principles and digital learning platforms (e.g., LMS, Confluence, knowledge bases).
• Experience aligning process design with digital platforms that support clinical trial execution (e.g., CTMS, eTMF, workflow automation tools).
• Background in large-scale organizational transformation, change enablement, or process optimization initiatives.

Responsibilities:

• Design and implement a comprehensive documentation framework for clinical trial processes, integrating changes from technology enablement and operating model updates.
• Contribute to and implement R&D standards for document types including SOPs, work instructions, guidance documents and training content ensuring alignment with regulatory requirements and internal quality expectations with a focus on logical flows and linkages.
• Solicit and identify operational dependencies impacting documentation design and implementation from deep clinical trial experts to shape process transformation strategies.
• Direct partner vendors providing technical writing, business process mapping, and change management support. Ensure outputs are aligned with strategic goals and delivered on time.
• Collaborate with business process owners (BPO), transformation leads, Quality and QMS teams, and learning and development partners to ensure documentation supports process clarity, compliance, and usability.
• Lead the tracking and reconciliation between future-state and current-state process taxonomy. Develop and implement a systematic approach for tracking and mapping implementation of process changes on trials newly starting up or migrating to new processes
• Partner with training and change management leads to ensure new or updated documentation enables effective process understanding, critical thinking and behavior change that drive collectively own operational excellence across all roles.
• Ensure all documentation supports GxP compliance and inspection readiness. Maintain a high standard of quality, traceability, and audit ability.
• Take a forward-thinking, “clean slate” approach to design future-state documentation and processes that are user-centric, intuitive, and connected across functions.
• Establish accountability structures for business process owners to support document lifecycle management, including periodic review and updates to ensure ongoing relevance and compliance. Measure key performance metrics of documentation effectiveness in conjunction with BPOs (e.g. User Readability, Process Compliance, Approach Consistency and Speed to Contribution)