Oncology Clinical Development Lead (GU)

Regulatory Jobs

Waltham (MA)

Hybrid

USD 190,000 - 316,000

Full time

5 days ago
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Benefits offered by this job

Health care
Retirement benefits
Paid holidays
Parental and caregiver leave

Job summary

GSK is seeking a Medical Director, Oncology Clinical Development for GU studies. This hybrid role combines clinical pharmacology with regulatory and cross-functional leadership to ensure patient safety and data integrity across oncology trials.

The position emphasizes medical monitoring, protocol development input, and collaboration with external investigators and internal teams to inform program decisions in GU oncology. Relocation considerations apply for UK sites.

Qualifications

  • MD or equivalent medical degree with oncology board cert/eligibility.
  • Clinical trial experience in oncology with monitoring and data interpretation.
  • Strong knowledge of GCP, ICH guidelines, and global regulatory frameworks.
  • Ability to work in cross-functional matrix teams.
  • Excellent scientific communications skills.

Responsibilities

  • Lead medical monitoring for assigned oncology clinical studies.
  • Conduct safety oversight and real-time decision making.
  • Interpret clinical data to assess safety and efficacy.
  • Contribute to regulatory submissions and Health Authority interactions.
  • Collaborate with cross-functional teams to integrate medical considerations.
  • Engage investigators and KEEs to support study conduct.

Skills

Analytical Thinking
Clinical Data Interpretation
Clinical Data Review
Clinical Development
Clinical Trial Designs
Clinical Trials Monitoring
Digital Fluency
Drug Regulatory Affairs
Executive Presence
Hematology and Oncology
Learning Agility
Matrix Leadership
Real World Evidence
Scientific Presentations

Education

MD (or equivalent medical degree) with oncology board cert/eligibility

Job description

GSK is seeking a Medical Director, Oncology Clinical Development for GU studies. This hybrid role combines clinical pharmacology with regulatory and cross-functional leadership to ensure patient safety and data integrity across oncology trials.

The position emphasizes medical monitoring, protocol development input, and collaboration with external investigators and internal teams to inform program decisions in GU oncology. Relocation considerations apply for UK sites.

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