GSK

Manager, Clinical Development

GSK

full-time

Posted on:

Location Type: Office

Location: Durham • North Carolina • United States

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About the role

  • Provide scientific leadership, direction, and contribution to the strategy employed in early clinical development programs.
  • Contribute to the study team in the design and development of high quality, timely studies.
  • Contributes to the medical governance and regulatory reporting at the study level.
  • Liaises with Clinical Pharmacology, Medical, Commercial, and Asset Leads to ensure study evaluates key aspects of the Asset Product Profile.
  • Contributes to the scientific oversight of clinical studies, including assurance that data collection and study analysis plans are aligned with the protocols.
  • Works closely with study physician(s) to help monitor safety and benefit/risk for studies.
  • Contributes to quality assurance and inspection readiness activities.

Requirements

  • B.S., Masters, Ph.D., Pharm.D., or MD with 3 plus years of recent clinical drug development experience.
  • 3 plus years contributing to a team, 3rd parties, academic partners, and subcontracted organizations.
  • Experience with managing multiple programs concurrently.
  • Prior experience in early clinical development (Phase 1 and 2 studies) or late stage clinical development (Phase 3 studies) preferred.
  • Prior HIV drug development experience strongly preferred and antiviral, or infectious disease therapeutic area.
  • Ability to respond with confidence to complex study questions using sound judgment and interpretation of applicable data.
  • Ability to communicate complex scientific information concisely and clearly.
  • Ability to influence (internally and externally) without formal authority.
Benefits
  • ViiV offers US employees receive the same benefits options and plans as GSK employees.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
clinical drug developmentstudy designdata collectionstudy analysisquality assuranceinspection readinesssafety monitoringbenefit/risk assessmentregulatory reportingscientific oversight
Soft Skills
leadershipcommunicationinfluenceteam collaborationjudgmentproblem-solvingstrategic thinkinginterpersonal skillsadaptabilityconciseness
Certifications
B.S.MastersPh.D.Pharm.D.MD