Senior Director, Clinical and Regulatory Strategic Communications - Hybrid

Key Responsibilities
- Serve as a strategic partner to the Head of CRSC, aligning priorities, resources, and execution.
- Lead annual strategic planning, operating model development, and priority-setting.
- Establish governance structures, decision frameworks, and initiative tracking.
- Coordinate across CRSC and partner functions (Clinical Development, Regulatory Affairs, Data/IT, Quality).
- Develop executive-level communications (leadership updates, town halls, strategic messaging).
- Translate enterprise/functional strategies into programs, milestones, and measurable outcomes.
- Develop and oversee dashboards, metrics, and reporting.
- Drive change management, communication, and adoption of new processes/technologies.
- Align CRSC initiatives with broader GCTO transformation efforts.
- Define workforce strategies to support evolving AI/digital/operational capabilities.
- Foster innovation, accountability, and continuous improvement.

Technology Strategy & Digital Enablement
- Define and advance the CRSC technology/innovation roadmap.
- Oversee development, implementation, and optimization of CRSC tools.
- Partner with IT/digital for enterprise architecture, data governance, and compliance standards.
- Guide technology investment decisions (build vs. buy; vendor selection/oversight).
- Ensure technology/AI initiatives align with clinical regulatory requirements, quality standards, and inspection readiness.

AI Strategy & Innovation
- Lead AI-enabled use cases (draft generation, summarization, review support, document comparison).
- Establish responsible AI governance (risk management, validation, regulatory compliance).
- Develop prompt libraries, reusable workflows, and training for adoption.
- Define and track KPIs (cycle time, quality, operational efficiency).

Qualifications
- Bachelor’s degree or higher in health/scientific/technology or related discipline; 15+ years relevant pharmaceutical/biotech industry experience.

Required Experience
- Deep knowledge of regulatory document requirements (CTD assembly/structure/content/formatting/quality control and submission/transmission) and regulator request management.
- Knowledge of global/local disclosure laws, end-to-end drug development, and clinical trial processes.
- Experience planning and leading strategic initiatives.

Preferred
- Experience leading digital transformation/technology modernization (platforms, automation, data/analytics, change adoption) and adopting pragmatic AI with appropriate governance.

Required Skills
- Strong interpersonal/communications skills; ability to drive/manage complex topics.
- Strong decision-making/analytical skills; leadership in matrix environments.
- Advanced problem solving, conflict resolution, critical thinking.
- Expert knowledge of GCP and ICH regulations and corporate policies.

Benefits
- Annual bonus and long-term incentive (if applicable).
- Comprehensive benefits including medical/dental/vision, retirement (401(k)), paid holidays, vacation, and compassionate/sick days.

Application Instructions
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees).