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Senior Director, Clinical Development Rare Disease
2 months ago
We are seeking a highly experienced and skilled Senior Director, Clinical Development Rare Disease to join our team at Amgen. As a key member of our Clinical Development organization, you will play a critical role in planning and executing clinical drug development across our clinical programs.
Key Responsibilities- Lead the development of clinical development strategies and plans for rare disease therapeutic areas
- Collaborate with cross-functional teams to design and execute clinical trials, including protocol development, site selection, and data management
- Provide medical and scientific expertise to support the development of clinical trial protocols, informed consent forms, and other study-related documents
- Ensure compliance with regulatory requirements, including FDA regulations and guidelines
- Develop and maintain relationships with key stakeholders, including investigators, site staff, and regulatory agencies
- Provide medical and scientific expertise to support the development of clinical trial reports, abstracts, and presentations
- Stay up-to-date with the latest scientific and clinical literature and apply this knowledge to inform clinical development strategies
- MD or DO from an accredited medical school
- 5+ years of industry or academic research experience
- 6+ years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources
- 10+ years of experience in biopharmaceutical sponsored clinical research
- Biopharmaceutical experience as a medical monitor and clinical lead across therapeutic areas
- Solid understanding of relevant areas such as biostatistics, regulatory, clinical pharmacology, pre-clinical toxicology approaches
- Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements
- Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication
- Ability to analyze and interpret complex datasets
At Amgen, our mission is to serve patients by pushing the boundaries of science to transform medicine and turn the tide on serious illnesses. We are committed to creating a workplace that is inclusive, diverse, and empowering for all staff members. We offer a comprehensive benefits package, including health and welfare plans, financial plans, work/life balance, and career development opportunities.
