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#WeareBiotech
Clinical Research Medical Director – Oncology
Location
United States
Posted
114 days ago
Salary
$291.2K - $351.8K / year
Seniority
Lead
Job Description
Clinical Research Medical Director – Oncology
Amgen
• Support Clinical Development in Prostate cancer • Supporting the development, execution and communication of the global scientific/medical evidence plan • Supporting cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program • Supporting the development of key scientific external relationships with opinion leaders • Participating and providing clinical input into safety and regulatory interactions • Provide clinical/scientific input during the development and execution of clinical trials • Interpret clinical trial data • Participate in safety assessments • Participate in interactions with regulatory agencies • Author CSRs, publications and regulatory submissions • Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by Global Development Leader • Identify new clinical research opportunities • Support in-licensing and out-licensing activities and partner relationships • Support product lifecycle management for new indications as directed by Global Development Leader • Provide clinical content input to: Regulatory interactions and documents; Safety interactions and documents; Materials to be used in Scientific Affairs; Materials to be used by the Commercial Organization
Job Requirements
- MD or DO degree from an accredited medical school AND 2 years of clinical research experience and/or basic science research
- 5+ years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities, particularly in GU Oncology (prostate cancer)
- Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company)
- In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale
- Familiarity with concepts of clinical research and clinical trial design, including biostatistics
- Sound scientific and clinical judgment
- Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP 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
- Demonstrated ability as a medical expert in a complex matrix environment
- History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues
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
- 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
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