Senior Oncology Clinical Development Lead

Jobtailor

Maryland

On-site

USD 180,000 - 240,000

Full time

7 days ago
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Job summary

Jobtailor is seeking a senior leader in clinical development, specializing in oncology, to drive study concepts, protocols, and governance across global programs. The role requires deep regulatory knowledge, GCP expertise, and a track record of leading complex drug development efforts.

The successful candidate will own clinical rationale, coordinate cross-functional teams, and mentor staff while ensuring alignment with safety and regulatory expectations in a global context.

Qualifications

  • PharmD, Ph.D. or MD degree required.
  • 7+ years of industry or academic drug development experience.
  • Oncology experience highly preferred.
  • Foundational knowledge of FDA and major country regulations.
  • GCP and regulatory knowledge essential.
  • Experience with protocol design, writing, and implementation.
  • Strong communication and presentation skills.
  • Experience leading clinical reports and integrated summaries.

Responsibilities

  • Convert program strategy into study concepts, protocols, forms, and shells.
  • Own the clinical rationale and integrity of protocols and plan components.
  • Deliver protocols and secure governance approvals.
  • Lead study-level medical monitoring and safety reviews when applicable.
  • Provide clinical input to feasibility questionnaires and country/site selection.
  • Collaborate across global teams and time zones.
  • Support regulatory submissions and health authority interactions.
  • Mentor and develop junior team members and provide line management as appropriate.

Skills

Clinical development leadership
Regulatory knowledge
GCP knowledge
Medical monitoring
Study design
Data interpretation
Cross-functional collaboration
Mentoring
Global trials
Stakeholder management

Education

PharmD
Ph.D. in Life Sciences
MD

Job description

Jobtailor is seeking a senior leader in clinical development, specializing in oncology, to drive study concepts, protocols, and governance across global programs. The role requires deep regulatory knowledge, GCP expertise, and a track record of leading complex drug development efforts.

The successful candidate will own clinical rationale, coordinate cross-functional teams, and mentor staff while ensuring alignment with safety and regulatory expectations in a global context.

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