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.

Preferred Skills

• Leading digital transformation and technology modernization efforts—including platform implementations, automation, data and analytics enablement, and change adoption—while driving the adoption of pragmatic AI and other technology solutions in alignment with scientific and regulatory standards, quality expectations, and appropriate governance controls.