Director, Global Regulatory Lead – Obesity & Related Conditions (Chronic Weight)

Key Responsibilities

• Develop and lead global regulatory strategy for obesity and metabolic disease programs, with specific focus on Chronic Weight, grounded in a strong understanding of metabolic biology, endocrine pathways, adiposity-related physiology, and cardiometabolic risk science.
• Integrate clinical, nonclinical, CMC, and safety evidence into cohesive regulatory recommendations, accounting for regulatory precedent in obesity and related conditions.
• Lead the creation of the Global Regulatory Strategic Plan (GRSP), including risk assessment, regulatory scenario planning, and evaluation of novel/expedited pathways.
• Advises on key clinical development elements relevant to obesity programs—study designs, chronic treatment safety, cardiovascular outcomes evaluation, metabolic biomarker selection, pediatric development, and real-world evidence plans.

Cross-Functional Influence & Enterprise Collaboration

• Lead the Global Regulatory Team (GRT) and represent Global Regulatory Affairs and Strategy (GRAAS) on cross-functional teams (e.g. Indication Team, Evidence Generation Team, Global Safety Team etc.).
• Partner closely with Clinical Development, Safety, CMC, Value & Access, Commercial, and regional regulatory colleagues to ensure seamless strategy execution.
• Translate complex metabolic science into actionable regulatory strategy for cross-functional partners, facilitating alignment on risk–benefit thinking and long-term labeling strategy.

Regulatory Execution & Documentation Excellence

• Oversee execution of major global regulatory submissions, including clinical trial applications, initial and supplemental marketing applications, pediatric plans, and labeling updates relevant to obesity programs.
• Ensure consistency, scientific rigor, and clarity across core regulatory documents—especially TPL, CDS, and briefing materials.
• Guides the regulatory interpretation of evolving FDA/EMA guidance related to obesity and related conditions (where applicable).

HA & External Stakeholder Engagement

• Lead strategy development, preparation, and cross-functional alignment for key Health Authority interactions (FDA, EMA, PMDA, NMPA, etc.) related to metabolic disorders, including protocol advice, CV safety considerations, efficacy endpoints, long-term safety monitoring, and pediatric/labeling discussions.
• Represent Amgen in external alliances, consortia, scientific policy discussions, and trade associations focused on obesity, metabolic disease, or cardiometabolic health.
• Anticipate HA perspectives informed by precedent in the obesity space (e.g., benefit–risk expectations, CV outcomes requirements, weight-loss durability concerns) and prepare teams for high-stakes discussions.

People Leadership, Team Performance & Cultural Agility

• Build, mentor, and support high-performing global regulatory teams.
• Foster an inclusive, collaborative environment that encourages diverse perspectives, scientific rigor, and healthy debate.
• Develop regulatory talent with expertise in metabolic disease science, regulatory strategy, and global execution.