Global Regulatory Director Lead – Obesity & Related Conditions, Type II Diabetes

🕒 il y a 2 mois

🇺🇸 États-Unis – Télétravail

💵 $189 632 - $256 561 / an

⏰ Temps Plein

🟠 Senior

🚔 Conformité

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Amgen

Site WebLinkedInTous les Emplois

10 000+ employés

Fondée en 1980

🧬 Biotechnologie

💊 Pharmaceutique

🔬 Science

💰 €28 500 000 000 Post-IPO Debt en 2022-12

Biotechnology • Pharmaceuticals • Science

Amgen est un leader mondial de la biotechnologie, se concentrant sur le développement et la commercialisation de médicaments innovants issus de cellules vivantes. L'entreprise vise à traiter des maladies graves, ciblant souvent des affections avec peu d'options thérapeutiques. Amgen met l'accent sur l'innovation scientifique et s'engage dans la recherche éthique, la sécurité des patients et le développement durable. Elle participe activement aux essais cliniques et est reconnue pour ses contributions dans les domaines du traitement du cancer et de la gestion de l'obésité, entre autres.

Description

• The Director, Global Regulatory Lead (GRL) provides strategic regulatory leadership for programs focused on obesity and related cardiometabolic conditions. • The GRL is accountable for developing and executing global regulatory strategies, shaping cross-functional decision-making, and leading global interactions with Health Authorities and external partners. • Develop and lead global regulatory strategy for obesity and metabolic disease programs with focus on Type II diabetes. • Integrate clinical, nonclinical, CMC, and safety evidence into cohesive regulatory recommendations. • Lead the creation of the Global Regulatory Strategic Plan (GRSP), including risk assessment and regulatory scenario planning. • Advise on key clinical development elements relevant to obesity programs. • Lead the Global Regulatory Team (GRT) and represent Global Regulatory Affairs and Strategy (GRAAS) on cross-functional teams. • Oversee execution of major global regulatory submissions, including clinical trial applications and marketing applications. • Lead strategy development and preparation for key Health Authority interactions related to metabolic disorders. • Build, mentor, and support high-performing global regulatory teams.

🎯 Exigences

• Doctorate degree and 4 years of regulatory experience OR Master’s degree and 7 years of regulatory experience OR Bachelor’s degree and 9 years of regulatory experience • 8–10+ years of global regulatory experience, with demonstrated leadership of regulatory strategy for programs in Type II diabetes, obesity, metabolic disorders, endocrinology, cardiovascular risk, or related therapeutic areas. • Strong scientific literacy in metabolism, energy balance physiology, hormone signaling pathways, adiposity biology, and associated clinical endpoints. • Experience developing global submissions and leading interactions with FDA, EMA, and other regulatory bodies. • Demonstrated success leading GRTs and influencing governance bodies on complex regulatory and clinical development issues. • Proven ability to translate metabolic science into clear regulatory strategy and decision-making frameworks. • Strong communication and negotiation skills, with the ability to guide teams through ambiguous or high-stakes situations. • Experience in real-world evidence strategy, long-term outcome measures, and chronic disease regulatory considerations is a plus.

🏖️ Avantages

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions • group medical, dental and vision coverage • life and disability insurance • flexible spending accounts • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible.