Director, Training Strategy & Process Enablement

The Director, Training Strategy & Process Enablement is responsible for the strategic design, implementation, and continuous improvement of Development-wide learning and capability programs that support operational excellence, compliance, inspection readiness, and workforce effectiveness. This leader will oversee Development-wide and trial-specific training strategies, ensuring employees, contractors, and external partners have the knowledge, skills, and tools required to execute clinical research activities in accordance with regulatory requirements and Moderna standards. The role serves as a critical bridge between process owners, Quality, Controlled Documentation, Clinical Operations, and functional stakeholders to translate business processes and procedural requirements into impactful learning solutions and measurable performance outcomes. The Director will establish scalable frameworks for role-based learning, change management, training effectiveness, and knowledge management while driving innovation in learning methodologies, digital learning technologies, and organizational capability development.

Responsibilities

Develop and execute the strategic vision for Development-wide training, learning, and capability programs aligned with organizational objectives, regulatory requirements, and business priorities; Establish and maintain training frameworks supporting both role-based and trial-specific learning requirements across Development functions; Partner closely with Business Process Owners (BPOs), Quality, and Controlled Document teams to ensure training requirements are effectively integrated into process development, process changes, and document lifecycle management; Lead the development and governance of training impact assessments associated with new or revised SOPs, Work Instructions, policies, systems, and process changes; Design and implement scalable learning strategies that support Development-specific onboarding, role progression, inspection readiness, and continuous professional development; Serve as the primary Development representative for training-related initiatives associated with enterprise Quality Management System (QMS) programs, global policies, change controls, and compliance initiatives; Drive adoption of process and system changes through integrated change management, communications, stakeholder engagement, and learning deployment strategies; Establish and monitor training effectiveness metrics, knowledge assessments, adoption measures, and performance indicators to ensure training outcomes translate into operational performance improvements; Collaborate with Clinical Operations, Medical, Safety, Data Management, Regulatory, Quality, and other Development functions to identify capability gaps and develop targeted learning solutions; Provide strategic oversight for trial-specific training programs, ensuring consistency, compliance, and appropriate governance across global studies; Leverage enterprise learning technologies, digital learning tools, and Learning Management System capabilities to enhance learner experience, reporting, and compliance. If needed, evaluate Development-specific learning technologies and partner with internal enterprise stakeholders to implement; Lead inspection and audit readiness activities related to training programs, training records, and competency management processes; Develop and maintain strategic partnerships with external vendors and learning partners supporting content development, training delivery, and learning technology solutions; Foster a culture of continuous improvement, innovation, knowledge sharing, and learning excellence across Development.

Requirements

BA/BS required; Minimum 8–10 years of experience within pharmaceutical, biotechnology, or clinical research environments; Significant experience leading enterprise learning, training, organizational capability, or process enablement programs; Demonstrated experience supporting GCP-regulated clinical development organizations; Strong understanding of clinical trial processes, quality systems, controlled documentation, and inspection readiness requirements; Experience partnering with Quality, Clinical Operations, and Business Process Owners to implement process and compliance initiatives; Working knowledge of Learning Management Systems (LMS), eLearning technologies, Veeva Vault, and digital learning platforms; Demonstrated success leading change management initiatives associated with process, technology, and organizational transformation; Strong analytical skills with experience developing KPIs, dashboards, and training effectiveness measures; Exceptional stakeholder management, communication, and influencing skills; Proven ability to lead cross-functional initiatives within a complex matrix environment.

Nice to have

Advanced degree preferred

Benefits

Competitive healthcare, plus voluntary benefit programs to support your unique needs; A holistic approach to well-being, with access to fitness, mindfulness, and mental health support; Family planning benefits, including fertility, adoption, and surrogacy support; Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown; Savings and investments to help you plan for the future; Location-specific perks and extras; Eligibility for an annual discretionary bonus, other incentive compensation, or equity award