[Remote] Clinical Development Director- Cardiovascular
Note: The job is a remote job and is open to candidates in USA. Amgen is a leading biotechnology company focused on serving patients with serious illnesses. The Clinical Development Director for Cardiovascular will lead medical and clinical development activities, ensuring strategic execution across various stages of clinical trials while collaborating with cross-functional teams.
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