Senior Director, Clinical and Regulatory Strategic Communications - Hybrid

Key Responsibilities

• 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.

Technology Strategy & Digital Enablement

• 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.

AI Strategy & Innovation

• 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.

Qualifications

• Bachelor’s degree or higher preferably in a health, scientific, technology or relevant discipline (e.g., life sciences, pharmacy, medicine, public health).
• At least 15+ years relevant pharmaceutical or biotech industry (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.

Required Skills

• Strong interpersonal and communications skills.
• Demonstrated ability to drive and manage highly complex topics.
• Strong decision-making and analytical skills.
• Ability to influence and drive a broader view of issues to maximize benefit and/or impact across the organization.
• Demonstrated leadership skills in managing people, programs, processes, leading meetings and influencing matrix environments.
• Advanced problem solving, conflict resolution, and critical thinking skills.
• Expert knowledge of GCP and ICH regulations and corporate policies.