Clinical Development Director – Cardiovascular

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $274.8k - $371.8k / year

⏰ Full Time

🔴 Lead

👔 Director

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Amgen

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1980

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 $28.5G Post-IPO Debt on 2022-12

Biotechnology • Pharmaceuticals • Science

Amgen is a global leader in biotechnology, focusing on the development and commercialization of innovative medicines made from living cells. The company aims to treat serious illnesses, often targeting diseases with limited therapeutic options. Amgen emphasizes scientific innovation and is committed to ethical research, patient safety, and environmental sustainability. It actively engages in clinical trials and is known for its contributions to the fields of cancer treatment and obesity management among others.

📋 Description

• 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.

🎯 Requirements

• 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.

🏖️ Benefits

• 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.