[Remote] Clinical Development Director- Cardiovascular
Note: The job is a remote job and is open to candidates in USA. Amgen is a biotechnology company focused on serving patients with serious illnesses. They are seeking a Clinical Development Director for Cardiovascular to lead medical and clinical development activities, providing clinical strategy and leadership for cardiovascular assets throughout their development stages.
Responsibilities
- Provide clinical and medical leadership for one or more General Medicine programs or studies
- Support the development, execution, and communication of global clinical development and evidence-generation strategies for cardiovascular assets across all stages of development
- Collaborate with cross-functional 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, academic investigators, cardiovascular societies, 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, including protocols, investigator brochures, clinical study reports, briefing books, safety narratives, and regulatory responses
- Contribute clinical expertise to safety evaluations, risk-benefit assessments, and pharmacovigilance activities
- Participate in regulatory interactions and support submissions to global health authorities, including FDA, EMA, PMDA, and other regulatory agencies
- Interpret clinical trial results and contribute to data-driven development decisions
- Present scientific and clinical data at advisory boards, steering committees, investigator meetings, scientific congresses, and other external 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, including label expansion opportunities and new cardiovascular indications
- Provide clinical content and strategic input for: Regulatory submissions and agency interactions, Safety assessments and governance reviews, Medical Affairs and Scientific Affairs materials, Health economics and outcomes research initiatives, Commercial and market access strategies
Skills
- MD or DO degree from an accredited medical school
- 2 years of clinical development experience
- MD, or equivalent medical degree
- 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)
- Demonstrated experience in clinical development, translational medicine, medical affairs, or related drug-development functions
- 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
- Ability to influence without authority and effectively collaborate across functions, regions, and external stakeholders
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, and 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. Refer to the Work Location Type in the job posting to see if this applies.
Company Overview
Company H1B Sponsorship