Director, Global Regulatory Lead – Obesity & Related Conditions (Chronic Weight)
Amgen
7 months ago
Remote friendly (Thousand Oaks, CA)
United States
Corporate Functions
Director, Global Regulatory Lead – Obesity & Related Conditions (Chronic Weight)
Responsibilities:
- Develop and lead global regulatory strategy for obesity/metabolic disease programs (Chronic Weight) using expertise in metabolic biology, endocrine pathways, adiposity-related physiology, and cardiometabolic risk science.
- Integrate clinical, nonclinical, CMC, and safety evidence into regulatory recommendations, accounting for obesity regulatory precedent.
- Lead creation of the Global Regulatory Strategic Plan (GRSP): risk assessment, regulatory scenario planning, and evaluation of novel/expedited pathways.
- Advise on clinical development elements for obesity programs: study designs, chronic treatment safety, CV outcomes evaluation, metabolic biomarker selection, pediatric development, and real-world evidence plans.
- Lead the Global Regulatory Team (GRT) and represent Global Regulatory Affairs and Strategy (GRAAS) on cross-functional teams.
- Partner with Clinical Development, Safety, CMC, Value & Access, Commercial, and regional regulatory teams to execute strategy.
- Oversee major global regulatory submissions (clinical trial applications, initial/supplemental marketing applications, pediatric plans, labeling updates).
- Ensure consistency, scientific rigor, and clarity across core regulatory documents (e.g., TPL, CDS, briefing materials).
- Guide interpretation of evolving FDA/EMA obesity guidance (where applicable).
- Lead strategy and cross-functional alignment for Health Authority interactions (FDA, EMA, PMDA, NMPA), including protocol advice, CV safety/efficacy endpoints, long-term safety monitoring, and pediatric/labeling discussions.
- Represent Amgen in external alliances/consortia and policy/trade discussions focused on obesity/metabolic health.
- Build, mentor, and support high-performing global regulatory teams.
Qualifications:
- Doctorate degree with 4 years regulatory experience OR Master’s degree with 7 years regulatory experience OR Bachelor’s degree with 9 years regulatory experience.
Preferred Qualifications / Skills:
- 8–10+ years global regulatory experience with leadership of regulatory strategy for chronic weight/obesity/metabolic disorders (endocrinology, cardiovascular risk or related areas).
- Strong scientific literacy in metabolism/energy balance, hormone signaling, adiposity biology, and clinical endpoints.
- Experience developing global submissions and leading interactions with FDA, EMA, and other regulators.
- Demonstrated success leading GRTs and influencing governance bodies on complex regulatory and clinical development issues.
- Ability to translate metabolic science into clear regulatory strategy and decision-making frameworks.
- Strong communication and negotiation skills to guide teams in ambiguous/high-stakes situations.
- Plus: experience with real-world evidence strategy, long-term outcome measures, and chronic disease regulatory considerations.
Benefits (as stated): Total Rewards Plan (eligibility-based) including health and welfare plans, financial plans for retirement/savings goals, work/life balance, and career development; comprehensive employee benefits (retirement and savings plan with company contributions, medical/dental/vision, life/disability insurance, flexible spending accounts), discretionary annual bonus/incentive plan (field sales), stock-based long-term incentives, time-off plans, and flexible work models where possible.
Application instructions:
- Apply via careers.amgen.com. Amgen does not have an application deadline for this position; applications are accepted until a sufficient number are received or a candidate is selected.
Responsibilities:
- Develop and lead global regulatory strategy for obesity/metabolic disease programs (Chronic Weight) using expertise in metabolic biology, endocrine pathways, adiposity-related physiology, and cardiometabolic risk science.
- Integrate clinical, nonclinical, CMC, and safety evidence into regulatory recommendations, accounting for obesity regulatory precedent.
- Lead creation of the Global Regulatory Strategic Plan (GRSP): risk assessment, regulatory scenario planning, and evaluation of novel/expedited pathways.
- Advise on clinical development elements for obesity programs: study designs, chronic treatment safety, CV outcomes evaluation, metabolic biomarker selection, pediatric development, and real-world evidence plans.
- Lead the Global Regulatory Team (GRT) and represent Global Regulatory Affairs and Strategy (GRAAS) on cross-functional teams.
- Partner with Clinical Development, Safety, CMC, Value & Access, Commercial, and regional regulatory teams to execute strategy.
- Oversee major global regulatory submissions (clinical trial applications, initial/supplemental marketing applications, pediatric plans, labeling updates).
- Ensure consistency, scientific rigor, and clarity across core regulatory documents (e.g., TPL, CDS, briefing materials).
- Guide interpretation of evolving FDA/EMA obesity guidance (where applicable).
- Lead strategy and cross-functional alignment for Health Authority interactions (FDA, EMA, PMDA, NMPA), including protocol advice, CV safety/efficacy endpoints, long-term safety monitoring, and pediatric/labeling discussions.
- Represent Amgen in external alliances/consortia and policy/trade discussions focused on obesity/metabolic health.
- Build, mentor, and support high-performing global regulatory teams.
Qualifications:
- Doctorate degree with 4 years regulatory experience OR Master’s degree with 7 years regulatory experience OR Bachelor’s degree with 9 years regulatory experience.
Preferred Qualifications / Skills:
- 8–10+ years global regulatory experience with leadership of regulatory strategy for chronic weight/obesity/metabolic disorders (endocrinology, cardiovascular risk or related areas).
- Strong scientific literacy in metabolism/energy balance, hormone signaling, adiposity biology, and clinical endpoints.
- Experience developing global submissions and leading interactions with FDA, EMA, and other regulators.
- Demonstrated success leading GRTs and influencing governance bodies on complex regulatory and clinical development issues.
- Ability to translate metabolic science into clear regulatory strategy and decision-making frameworks.
- Strong communication and negotiation skills to guide teams in ambiguous/high-stakes situations.
- Plus: experience with real-world evidence strategy, long-term outcome measures, and chronic disease regulatory considerations.
Benefits (as stated): Total Rewards Plan (eligibility-based) including health and welfare plans, financial plans for retirement/savings goals, work/life balance, and career development; comprehensive employee benefits (retirement and savings plan with company contributions, medical/dental/vision, life/disability insurance, flexible spending accounts), discretionary annual bonus/incentive plan (field sales), stock-based long-term incentives, time-off plans, and flexible work models where possible.
Application instructions:
- Apply via careers.amgen.com. Amgen does not have an application deadline for this position; applications are accepted until a sufficient number are received or a candidate is selected.