Clinical Development Director – Obesity, Cardiovascular

🕒 Setembro 24

🇺🇸 Estados Unidos – Remoto (EUA)

⏰ Tempo Integral

🔴 Especialista

👔 Diretor

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Amgen

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1980

🏥 Saúde

🧬 Biotecnologia

💊 Farmacêutico

💰 $28.500.000.000 Post-IPO Debt em 2022-12

Healthcare • Biotechnology • Pharmaceuticals

A Amgen está comprometida a liberar o potencial da biologia para pacientes que sofrem de doenças graves, descobrindo, desenvolvendo, fabricando e fornecendo terapias humanas inovadoras. Esta abordagem começa utilizando ferramentas como genética humana avançada para desvendar as complexidades das doenças e entender os fundamentos da biologia humana.

Descrição

• Provide clinical/scientific knowledge for the development, design, delivery, and communication of the global evidence generation plan for the AMG 133 Phase 3 program • Work cross-functionally to translate clinical strategy into study concept documents, protocols, and related documents • Provide clinical input into and implement clinical trials • Review clinical data and interpret results • Serve as medical monitor for ongoing clinical trials • Review and analyze clinical trial data for accuracy, completeness, protocol adherence, and regulatory compliance • Participate in and provide clinical input into safety and regulatory interactions • Author clinical study reports, publications, and regulatory submissions • Develop relationships with key opinion leaders • Make scientific presentations at advisory boards, scientific meetings, and external committee meetings • Report directly to the Global Development Lead for cardiovascular indications

🎯 Requisitos

• MD or DO degree from an accredited medical school • 3 years of clinical research experience • Three (3) or more years of clinical research experience in the biopharmaceutical industry preferred • Five or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities preferred • Knowledge of pharmaceutical product development, product lifecycle, and commercialization processes • Experience developing study concepts for clinical development and clinical trial designs with cross-functional input in Phase 2 and/or 3 clinical trials in obesity, diabetes or cardiovascular indications • Experience with clinical trial medical data review, medical monitoring, and/or safety review and interpretation, including electronic aggregate data review tools • Experience drafting high-level submission documents for regulatory submissions, including clinical regulatory responses • Strong written and oral communication and presentation skills • Strong interpersonal skills and problem-solving abilities • Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements • Leadership experience or potential as a medical expert in a complex matrix environment

🏖️ Benefícios

• 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 • Discretionary annual bonus program • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible • Career development opportunities • Financial plans with opportunities to save towards retirement or other goals • Work/life balance support