#WeareBiotech
Clinical Development Director – Cardiovascular
Location
United States
Posted
3 days ago
Salary
$274.8K - $371.8K / year
Seniority
Lead
Job Description
Clinical Development Director – Cardiovascular
Amgen
• 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.
Job 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.
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