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Clinical Development Director – Cardiovascular
AmgenLead medical and clinical development activities for cardiovascular assets at Amgen. Collaborate with cross-functional teams to drive clinical strategy and execution.
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- 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.
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical developmentclinical trial designbiostatisticsadaptive trial methodologiesevidence-generation strategiescardiovascular clinical endpointsbiomarkersimaging modalitiesGood Clinical Practice (GCP)regulatory submissions
Soft Skills
influence without direct authorityscientific and clinical judgmentwritten communicationverbal communicationstrategic thinkingproblem-solvingdecision-makingcollaborationleadershiprelationship building
Certifications
MDDO