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Amgen

#WeareBiotech

Clinical Scientist Director – Late Development, Rare Disease

Clinical ResearchClinical ResearchFull TimeRemoteLeadTeam 10,001+Since 1980H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

6 days ago

Salary

$229.5K - $273.8K / year

Seniority

Lead

4 yrs expEnglish

Job Description

• Support late-phase clinical development by translating scientific and clinical strategy into actionable execution across clinical trials • 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. • Work cross functionally to ensure clinical strategy is translated into the development of the study concept document, study protocol, and related documents • Provide guidance and assistance in the identification and management of collaborators, consultants, and/or Clinical Research Organizations (CROs) in completion of key projects. • Provide clinical input into & implementation of clinical trial(s), 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. • Ensure integrity of protocols and/or components of clinical plans and for the delivery of final protocol and its governance approval. • Contribute to medical monitoring activities and support ongoing assessment of subject-level clinical data to identify trends, risks, and emerging issues. • 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. • Present information internally and externally, anticipating and actively managing problems across a broad spectrum of cross-functional teams.

Job Requirements

  • Doctorate degree and 4 years of clinical development experience OR Master’s degree and 7 years of clinical development experience OR Bachelor’s degree and 9 years of clinical development experience
  • 5 years of pharmaceutical clinical drug development experience
  • Strong preference for individuals with proven track record of clinical trial process improvement
  • Industry or academic experience in late-phase drug development for Inflammation Development Therapeutic Area.
  • Strong communication & presentation skills to clearly communicate scientific concepts /data to leadership committees both internally or externally (both written and oral)
  • Experience with designing, monitoring, and implementing clinical trials for the Inflammation Development Therapeutic Area and interpreting test results in compliance with Good Clinical Practice standards and regulatory requirements
  • Understanding of conducting study data readout activities, including data cleaning, data base lock, data extract, producing outputs of data
  • Experience drafting high level submission documents for regulatory submissions including authoring clinical regulatory responses for health regulatory interactions
  • Serving as a contributing author to scientific publications and data presentations at scientific conferences
  • Experience in clinical data analysis such as Spotfire or other data analysis tools.

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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