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Amgen

Makes biotech medicines for serious illnesses

Clinical Scientist Director - Late Development Oncology

Clinical Research OperationsConfirmed live in the last 24 hours
Full-time

About the Job

Requirements

  • A doctorate degree and 4 years of life sciences or healthcare experience, or a master's degree and 7 years of life sciences or healthcare experience, or a bachelor's degree and 9 years of life sciences or healthcare experience.

Responsibilities

  • Serve as a clinical and scientific subject-matter expert for the assigned therapeutic area and disease indication, with a strong focus on protocol execution and data integrity.
  • Contribute to medical monitoring activities and support ongoing assessment of subject-level clinical data to identify trends, risks, and emerging issues.
  • Present information internally and externally, anticipating and actively managing problems across a broad spectrum of cross-functional teams.
  • Provide guidance and assistance in the identification and management of collaborators, consultants, and/or Clinical Research Organizations in completion of key projects.
  • Work cross-functionally to ensure clinical strategy is translated into the development of the study concept document, study protocol, and related documents.
  • Ensure integrity of protocols and/or components of clinical plans and delivery of the final protocol and its governance approval.
  • Provide clinical input into and implementation of clinical trials, delivery, clinical data review, and interpretation of results.
  • Review and analyze clinical trial data to ensure accuracy, completeness, and adherence to protocol and regulatory requirements.
  • Conduct thorough data quality assessments in the context of a data monitoring plan to maintain high standards of data accuracy and integrity throughout the trial lifecycle.

Desired Qualifications

  • Five years of pharmaceutical clinical drug development experience.
  • A proven track record of clinical trial process improvement is strongly preferred.
  • Industry or academic experience in late-phase drug development for oncology.
  • Experience designing, monitoring, and implementing oncology clinical trials and interpreting test results in compliance with Good Clinical Practice standards and regulatory requirements.
  • Experience conducting study data readout activities, including data cleaning, database lock, data extract, and producing data outputs.
  • Experience drafting high-level submission documents for regulatory submissions, including authoring clinical regulatory responses for health regulatory interactions.
  • Experience contributing as an author to scientific publications and presenting data at scientific conferences.
  • Experience in clinical data analysis using Spotfire or other data analysis tools.
  • Strong communication and presentation skills to clearly communicate scientific concepts and data to leadership committees, internally or externally, in writing and orally.

About the Company

Amgen

Makes biotech medicines for serious illnesses

Amgen develops and makes biologic medicines, which are drugs built from proteins and antibodies grown in living cells, for serious conditions such as heart disease, cancer, and bone loss. Its anemia drug Epogen, approved in 1989, became one of the biotechnology industry's first blockbuster medicines. Amgen grows these drugs in large tanks called bioreactors, and its products include the cholesterol drug Repatha, the bone-building drug Evenity, and the severe asthma drug Tezspire. It earns money by selling these medicines, mostly through large drug wholesalers that supply hospitals and pharmacies. Amgen was founded in 1980 and is based in Thousand Oaks, California.

Company size
10,001+
Company stage
IPO
Headquarters
Thousand Oaks, CA
Founded
1980

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