Global Head, Regulatory Science (Model-Enabled Development, Real World Evidence and Novel Endpoints)

Location: Morristown, New Jersey, United States. Full-time role; 10% domestic and international travel expected. US and Puerto Rico residents only.

Salary: $266,250–$384,583 per year.

Company

hirify.global is an R&D-driven, AI-powered biopharmaceutical company developing medicines and vaccines based on immunoscience.

What you will do

• Provide strategic leadership, organizational design, people development, resource allocation, and succession planning for a regulatory science expert unit.
• Develop regulatory strategy frameworks for Model-Enabled Drug Development across development phases and therapeutic areas.
• Lead regulatory validation projects for innovative endpoints and oversee model-enabled, real-world evidence, and novel endpoint submissions.
• Engage with FDA, EMA, and other worldwide regulatory agencies on MIDD, modeling and simulation, real-world evidence, and novel endpoints.
• Build regulatory capabilities through best practices, SOPs, training programs, knowledge management, and external industry participation.
• Partner with Translational Medicine, Clinical Development, Biostatistics, Medical Affairs, and other R&D functions to resolve complex technical and regulatory issues.

Requirements

• Must be based in the United States or Puerto Rico.
• 10–15 years of regulatory affairs experience with progression in regulatory roles and successful health authority interactions.
• Experience with Model-Informed Drug Development, pharmacometrics, modeling and simulation, novel endpoint development, or advanced regulatory submissions.
• Leadership experience in building and developing specialized teams, including recruitment, coaching, talent management, and succession planning.
• Strong knowledge of model-enabled regulatory frameworks, novel endpoint validation pathways, and regulatory science trends.
• Bachelor’s degree required; an advanced degree in a quantitative science or health sciences field is highly desirable.

Nice to have

• Experience establishing centers of excellence or expert units.
• Experience working with or for a regulatory health authority.
• Advanced degree such as a Master’s, PharmD, or PhD.

Culture & Benefits

• Supportive, future-focused environment centered on scientific innovation and patient outcomes.
• Opportunities for promotion, lateral career development, and international growth.
• Rewards package linked to contribution and impact.
• Healthcare, prevention, wellness, and family benefits.
• At least 14 weeks of gender-neutral parental leave.