Senior Director, Clinical and Regulatory Strategic Communications - Hybrid

Job Description

The Clinical and Regulatory Strategic Communications (CRSC) department within GCTO creates and delivers high-quality regulated content in support of our development pipeline and enables data sharing for our customers. We are a strategic partner that ensures excellence and compliance with applicable laws while incorporating health literacy principles in the development of public-facing materials.

The Senior Director of Strategy, Technology & Operations is a key strategic and operational partner to the Head of CRSC, enabling execution of CRSC priorities across the organization. This role integrates enterprise strategy execution, operational leadership, and technology innovation to advance efficiency, quality, and scalability across CRSC. The position is responsible for translating strategic priorities into actionable programs, leading cross‑functional initiatives, and advancing AI‑ and technology‑enabled capabilities to modernize CRSC processes.

• Serve as a strategic partner to the Head of CRSC, ensuring alignment of priorities, resources, and execution.
• Lead annual strategic planning, operating model development, and priority‑setting for CRSC.
• Establish and maintain governance structures, including leadership forums, decision frameworks, and initiative tracking.
• Drive coordination across CRSC and partner functions (e.g., Clinical Development, Regulatory Affairs, Data/IT, Quality).
• Develop executive‑level communications (e.g., leadership updates, town halls, strategic messaging).
• Translate enterprise and functional strategies into structured programs, milestones, and measurable outcomes.
• Support cross‑functional CRSC initiatives that enhance efficiency, quality, and scalability.
• Develop and oversee department dashboards, metrics, and reporting frameworks.
• Ensure effective change management, communication, and adoption of new processes and technologies.
• Support the Head of CRSC in aligning initiatives with broader GCTO transformation efforts.
• Define workforce strategies to support evolving AI, digital, and operational capabilities.
• Foster a culture of innovation, accountability, and continuous improvement.

• Define and advance the CRSC technology and innovation roadmap aligned to GCTO and enterprise objectives.
• Oversee development, implementation, and optimization of tools supporting CRSC.
• Partner with IT and digital teams to ensure alignment with enterprise architecture, data governance, and compliance standards.
• Evaluate and guide technology investment decisions (build vs. buy; vendor selection and oversight).
• Ensure that all technology and AI initiatives align with clinical regulatory requirements, internal quality standards, and inspection readiness expectations.

• Lead identification and implementation of AI‑enabled use cases within CRSC (e.g., draft generation, summarization, review support, document comparison).
• Establish and maintain responsible AI governance, including risk management, validation approaches, and compliance with regulatory expectations.
• Drive development of prompt libraries, reusable workflows, and training approaches to enable adoption.
• Define and track KPIs to evaluate impact on cycle time, quality, and operational efficiency.

• Bachelor's degree or higher preferably in a health, scientific, technology or relevant discipline (e.g., life sciences, pharmacy, medicine, public health) and at least 15+ years relevant pharmaceutical or biotech industry experience (e.g., medical writing, regulatory communications, or clinical development).

• Expertise and thorough knowledge of the regulatory requirements and technical specifications for the assembly, structure, content, formatting, quality control and submission/transmission of all documents for regulatory submissions using the CTD process and managing the associated requests from regulators.
• Expertise and understanding of global and local disclosure laws, end‑to‑end drug development, and clinical trial processes.
• Experience in planning and leading strategic initiatives.

• Experience…