Senior Director, Clinical and Regulatory Strategic Communications - Hybrid

Key Responsibilities

• Partner with Head of CRSC; lead annual strategic planning and priority-setting.
• Establish governance (forums, decision frameworks, initiative tracking) and coordinate cross-functionally (Clinical Development, Regulatory Affairs, Data/IT, Quality).
• Develop executive communications; translate strategies into programs, milestones, and measurable outcomes.
• Build dashboards, metrics, and reporting; lead change management and adoption of new processes/technologies.
• Define workforce strategy to support evolving AI/digital/operational capabilities.
• Lead CRSC technology and innovation roadmap; oversee tools development/implementation/optimization.
• Guide technology investments (build vs buy; vendor selection/oversight) and ensure alignment with regulatory requirements, quality standards, and inspection readiness.
• Identify and implement AI use cases (draft generation, summarization, review support, document comparison); establish responsible AI governance.
• Develop prompt libraries/workflows/training; define and track KPIs (cycle time, quality, efficiency).

• Bachelor’s+ (health/scientific/technology or related) and 15+ years pharma/biotech experience (e.g., medical writing, regulatory communications, clinical development).
• Deep CTD regulatory document assembly/quality/submission/transmission expertise; global/local disclosure laws; end-to-end drug development & clinical trial processes.

• Digital transformation/technology modernization; automation, data/analytics enablement; pragmatic AI adoption with governance.

• Interpersonal/communications; decision-making/analytics; lead complex topics and matrix environments; problem solving/conflict resolution; GCP/ICH and corporate policy expertise.

• Medical/dental/vision
• Retirement (401(k))
• Paid holidays, vacation, compassionate and sick days