Executive Director, Digital Regulatory and Safety

Executive Director, Digital Regulatory And Safety

At our company, we aspire to be the premier research-intensive biopharmaceutical company. We're at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We use the power of leading-edge science to save and improve lives around the world. Reporting to the Associate Vice President, Clinical and Development Digital Solutions (CDDS IT), the Executive Director, Digital Regulatory and Safety will lead our efforts in transforming regulatory submissions and pharmacovigilance through modern platforms and responsible generative AI.

Primary Responsibilities

• Develop and promote a multiyear product strategy for Digital Regulatory & Safety, aligning with IT and Research and Development (R&D) priorities, including prioritized roadmaps and investment cases to deliver enterprise value, focusing on innovation, risk, regulatory compliance, and scalability.
• Act as a senior technology business partner to various stakeholders, translating strategic needs into product investments.
• Define and drive adoption of target-state architecture and reusable capability layers across Regulatory and Pharmacovigilance, with a focus on integrated platforms and thoughtful end to end capabilities
• Lead the responsible adoption of generative AI technologies for regulatory authoring and translations across R&D, partnering with enterprise technology teams, Legal and Compliance
• Develop and support the practice of product management, building the mindset and practice of end-to-end accountability of product lifecycle, resolving uncertainty early through product discovery and agile practices, and identification of reusable patterns that enable scale and efficiency in product delivery.
• Build and scale a high-performing product organization, manage a group of 40-60 technology professionals, promoting career development and continuous upskilling of talent to build incredible teams and the ecosystem to empower them.
• Develop an external presence and strong internal networks to recruit highly skilled and diverse talent, stay current with industry trends, and establish effective vendor partnerships.

Education

Bachelor's degree in IT, computer science, life sciences, or related discipline; advanced degree preferred.

Required Experience and Skills

Preferred Experience and Skills

Required Skills

Asset Management, Benefits Management, Communication, Computer Science, Digital Strategy, Generative AI, Immunochemistry, Life Science, Management Process, Management System Development, Product Management, Product Management Leadership, Product Strategies, Regulatory Affairs Compliance, Regulatory Compliance, Requirements Management, Stakeholder Communications, Stakeholder Relationship Management, Strategic Planning, System Designs, Veeva Vault

Preferred Skills

Information on benefits and compensation is available at https : / / jobs.merck.com / us / en / compensation-and-benefits