Clinical Development Director – Cardiovascular

🕒 3 dias atrás

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $274.788 - $371.773 / ano

⏰ Tempo Integral

🔴 Especialista

👔 Diretor

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Amgen

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1980

🧬 Biotecnologia

💊 Farmacêutico

🔬 Ciência

💰 $28.500.000.000 Post-IPO Debt em 2022-12

Biotechnology • Pharmaceuticals • Science

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

• Lead medical and clinical development activities for assets within the General Medicine therapeutic area • Accountable for clinical strategy, study-level medical leadership, cross-functional decision-making, and support of program execution from early clinical development through late-stage studies • Partner closely with Clinical Operations, Regulatory, Safety, Biostatistics, Medical Affairs, Data Management, and other functional teams • Provide clinical and medical leadership for one or more General Medicine programs or studies • Support the development, execution, and communication of global clinical development strategies for cardiovascular assets across all stages of development • Collaborate with global teams to integrate medical, scientific, regulatory, commercial, and market access perspectives into development programs • Build and maintain strategic scientific relationships with key opinion leaders and external experts • Provide clinical and scientific leadership in the design, conduct, analysis, and interpretation of clinical trials • Contribute to the authoring and review of clinical documents, safety evaluations, and risk-benefit assessments • Participate in regulatory interactions and support submissions to global health authorities • Interpret clinical trial results and contribute to data-driven development decisions • Present scientific and clinical data at various forums as delegated by the Global Development Leader • Identify emerging scientific opportunities and unmet medical needs in cardiovascular medicine to inform future development strategies • Contribute to lifecycle management strategies and provide clinical content for regulatory submissions.

🎯 Requisitos

• MD or DO degree from an accredited medical school AND 2 years of clinical development experience • 5+ years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities in cardiovascular disease • Clinical research experience in the biopharmaceutical industry (biotechnology, pharmaceutical, or CRO environment) • Strong working knowledge of clinical trial design, execution, and interpretation, biostatistics, adaptive trial methodologies, and evidence-generation strategies • Proven ability to work across matrixed teams and influence without direct authority • Strong understanding of cardiovascular clinical endpoints, biomarkers, imaging modalities, and contemporary treatment guidelines • Sound scientific and clinical judgment with the ability to evaluate complex benefit-risk profiles • Working knowledge of Good Clinical Practice (GCP), FDA, EMA/CHMP regulations, ICH guidelines, and global regulatory requirements • Excellent written and verbal communication skills, including the ability to communicate complex scientific concepts to diverse audiences • Demonstrated success functioning as a medical leader within a highly matrixed global organization • Strong strategic thinking, problem-solving, and decision-making capabilities with a track record of delivering results in complex development programs.

🏖️ Benefícios

• 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.