Amgen is expanding its strategic leadership in the cardiometabolic space, seeking a Director, Global Regulatory Lead for Obesity & Related Conditions (Chronic Weight) to steer the development of next-generation treatments. The role, based in the United States, is designed to navigate the complex intersection of metabolic biology and global health authority requirements during a period of rapid innovation in weight-management therapeutics.
The position arrives as the biotech industry faces intensifying scrutiny and evolving standards for chronic weight treatments. The successful candidate will be responsible for translating intricate science—including endocrine pathways and adiposity-related physiology—into actionable regulatory strategies that can withstand the rigorous review processes of agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
By leading Global Regulatory Teams (GRT), this director will oversee the creation of Global Regulatory Strategic Plans (GRSP), managing the risk-benefit assessments and cardiovascular outcomes evaluations that often determine the commercial viability of metabolic drugs. This leadership is critical as Amgen continues to operate across its four core therapeutic pillars: Oncology, Inflammation, General Medicine, and Rare Disease.
The search for this lead reflects a broader industry shift toward treating obesity not merely as a lifestyle concern, but as a chronic disease requiring sophisticated, long-term clinical management and rigorous safety monitoring.
Navigating the Regulatory Landscape of Metabolic Science
The core of this role involves bridging the gap between laboratory discovery and market approval. Due to the fact that obesity and related cardiometabolic conditions are “rapidly evolving,” the lead must possess a deep scientific literacy in energy balance physiology and hormone signaling. The objective is to ensure that clinical trial designs and metabolic biomarker selections align with the current expectations of global regulators.
A primary focus for the Director will be the management of high-stakes interactions with Health Authorities. This includes not only the FDA and EMA but also the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan and the National Medical Products Administration (NMPA) in China. The lead must anticipate regulatory hurdles regarding weight-loss durability and the long-term safety of chronic treatments, areas where precedent is still being established.
Beyond the scientific strategy, the role demands high-level cross-functional orchestration. The Director will serve as the regulatory voice on Indication and Evidence Generation teams, ensuring that the data collected in the clinic translates directly into a favorable labeling strategy and a clear value proposition for payers, and providers.
Required Expertise and Professional Qualifications
Amgen has established a tiered set of qualifications based on academic background and professional experience to ensure the lead can handle the technical demands of the role. The requirements emphasize a blend of regulatory tenure and scientific depth.
| Academic Degree | Minimum Years of Experience |
|---|---|
| Doctorate (PhD/MD/PharmD) | 4 Years |
| Master’s Degree | 7 Years |
| Bachelor’s Degree | 9 Years |
While the above are the baseline, the company prefers candidates with 8 to 10+ years of global experience specifically within endocrinology, cardiovascular risk, or metabolic disorders. Preference is given to those who have a proven track record of leading global submissions and managing the nuances of real-world evidence strategy for chronic diseases.
Operational Impact and Enterprise Collaboration
The Director, Global Regulatory Lead – Obesity & Related Conditions (Chronic Weight) Jobs at Amgen in United States of America is not a siloed position; We see an influential hub within the Global Regulatory Affairs and Strategy (GRAAS) department. The lead is expected to mentor high-performing teams and foster a culture of scientific rigor and healthy debate.
Key operational deliverables include the oversight of clinical trial applications, initial and supplemental marketing applications, and the development of pediatric plans. The role requires a meticulous approach to documentation, specifically ensuring that Target Product Profiles (TPP) and Clinical Development Strategies (CDS) are scientifically sound and consistent across all global markets.
the lead will represent Amgen in external alliances and scientific policy discussions. By engaging with trade associations and consortia focused on cardiometabolic health, the director helps shape the very regulatory environment in which the company operates, advocating for science-based standards in obesity treatment.
Compensation and Organizational Support
Amgen integrates this role into a “Total Rewards Plan” designed to support long-term professional growth. While the base salary varies based on individual skills and experience, the package includes a discretionary annual bonus and stock-based long-term incentives. The company also offers flexible work models where applicable and comprehensive health and welfare plans.
The organization emphasizes an inclusive environment, allowing candidates to redact age-identifying information from their application materials to prevent bias. This approach is part of a broader commitment to maintaining a diverse workforce capable of tackling the world’s toughest diseases.
Disclaimer: This article is for informational purposes only and does not constitute professional medical or career advice. For official application details and legal terms, candidates should refer directly to the official Amgen careers portal.
Amgen has not set a firm application deadline for this position and will continue to review candidates until a sufficient number of qualified applicants are identified or a selection is made. Prospective candidates can find further details and submission portals at careers.amgen.com.
We invite our readers to share their perspectives on the evolving regulatory landscape for metabolic health in the comments below.
