[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.ResponsibilitiesProvide clinical and medical leadership for one or more General Medicine programs or studiesSupport the development, execution, and communication of global clinical development and evidence-generation strategies for cardiovascular assets across all stages of developmentCollaborate with cross-functional global teams to integrate medical, scientific, regulatory, commercial, and market access perspectives into development programsBuild and maintain strategic scientific relationships with key opinion leaders, academic investigators, cardiovascular societies, and external expertsProvide clinical and scientific leadership in the design, conduct, analysis, and interpretation of clinical trialsContribute to the authoring and review of clinical documents, including protocols, investigator brochures, clinical study reports, briefing books, safety narratives, and regulatory responsesContribute clinical expertise to safety evaluations, risk-benefit assessments, and pharmacovigilance activitiesParticipate in regulatory interactions and support submissions to global health authorities, including FDA, EMA, PMDA, and other regulatory agenciesInterpret clinical trial results and contribute to data-driven development decisionsPresent scientific and clinical data at advisory boards, steering committees, investigator meetings, scientific congresses, and other external forums as delegated by the Global Development LeaderIdentify emerging scientific opportunities and unmet medical needs in cardiovascular medicine to inform future development strategiesContribute to lifecycle management strategies, including label expansion opportunities and new cardiovascular indicationsProvide 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 strategiesSkillsMD or DO degree from an accredited medical school2 years of clinical development experienceMD, or equivalent medical degree5+ years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities in cardiovascular diseaseClinical research experience in the biopharmaceutical industry (biotechnology, pharmaceutical, or CRO environment)Demonstrated experience in clinical development, translational medicine, medical affairs, or related drug-development functionsStrong working knowledge of clinical trial design, execution, and interpretation, biostatistics, adaptive trial methodologies, and evidence-generation strategiesProven ability to work across matrixed teams and influence without direct authorityStrong understanding of cardiovascular clinical endpoints, biomarkers, imaging modalities, and contemporary treatment guidelinesSound scientific and clinical judgment with the ability to evaluate complex benefit-risk profilesWorking knowledge of Good Clinical Practice (GCP), FDA, EMA/CHMP regulations, ICH guidelines, and global regulatory requirementsExcellent written and verbal communication skills, including the ability to communicate complex scientific concepts to diverse audiencesDemonstrated success functioning as a medical leader within a highly matrixed global organizationStrong strategic thinking, problem-solving, and decision-making capabilities with a track record of delivering results in complex development programsAbility to influence without authority and effectively collaborate across functions, regions, and external stakeholdersBenefitsA 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 accountsA discretionary annual bonus program, or for field sales representatives, a sales-based incentive planStock-based long-term incentivesAward-winning time-off plansFlexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.Company OverviewAmgen is a biotechnology company that develops and manufactures human therapeutics for various illnesses and diseases. It was founded in 1980, and is headquartered in Thousand Oaks, California, USA, with a workforce of 10001+ employees. Its website is http://www.amgen.com.Company H1B SponsorshipAmgen has a track record of offering H1B sponsorships, with 42 in 2026, 429 in 2025, 485 in 2024, 485 in 2023, 540 in 2022, 460 in 2021, 444 in 2020. Please note that this does not guarantee sponsorship for this specific role.