Assoc Dir/Director Clinical Scientist

Added
18 days ago
Type
Full time
Salary
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data management gcp biostatistics clinical operations ich guidelines
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πŸ“‹ Description

  • Lead clinical study protocol development translating strategy into executable protocols.
  • Collaborate on trial design, CRF design, data review, and statistical analysis planning.
  • Review, analyze, and interpret study results; ensure data accuracy and reporting.
  • Identify and address study and program issues; literature reviews for next steps.
  • Coordinate with medical monitor on safety and efficacy data and study communications.
  • Support regulatory documents and clinical sections of submissions and reports.

🎯 Requirements

  • Advanced clinical or science degree (e.g., RN, MA, PharmD, NP, PhD).
  • MA + 5 years or PharmD/PhD + 3 years in clinical/pharmaceutical settings.
  • Experience in planning, executing, reporting and publishing clinical studies.
  • Ability to interpret and present clinical data; literature review skills.
  • Fluent English; strong knowledge of drug development from pre-IND to post-registration.
  • Understanding of trial design, statistics, and cross-functional collaboration.

🎁 Benefits

  • Competitive compensation with bonus potential; generous benefits package.
  • Equity and participation in annual target bonus; 401K with employer contributions.
  • Generous stock options; ESPP plan; PTO and holidays; diverse benefits.
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