Global Oncology Clinical Development Leader

Jobtailor; Maryland; On-site; USD 180,000 - 240,000; Full time

Job summary

Jobtailor is seeking an experienced clinical development leader with a strong oncology focus to own protocol design and governance. You will lead study-level medical monitoring, regulatory interactions, and cross-functional collaboration across global teams.

The role requires 7+ years in drug development, with a PharmD/PhD/MD and deep experience in GCP, NDA/BLA processes, and complex study designs. This is a high-impact, on-site Maryland opportunity.

Qualifications

• Oncology-focused clinical development expertise.
• Strong knowledge of GCP and regulatory requirements.
• Experience leading protocol development and integrated summaries.

Responsibilities

• Convert program strategy into study concept documents, protocols, ICFs, CRFs, TFL shells, and related materials.
• Own the scientific rationale and clinical integrity of protocols and clinical plan components.
• Deliver final protocols and secure governance approvals with Study Physician, GCPL, and GCH partners.
• Drive timely study initiation and execution with Clinical Operations, Program Management, GSTs, SMM, supply chain, and sample management.
• Identify recruitment risks, propose mitigations, and support implementation.
• Provide clinical input to feasibility questionnaires and country/site selection.
• Respond to site queries and EC/IRB requests.
• Lead study-level medical monitoring and safety reviews when applicable.
• Lead high-level clinical data reviews and interpretation.
• Prepare governance materials for Go/No-Go decisions.
• Lead development and delivery of clinical study reports.
• Support health authority interactions and regulatory and EC/IRB submissions.
• Provide clinical input to NDA/BLA registration packages.
• Collaborate on launch, branding materials, and publications.
• Partner with investigators, KEEs, MSLs, and SMMs on study design, feasibility, and recruitment.
• Contribute to advisory boards and deliver investigator and monitor training.
• Represent Clinical Development as a core GST member.
• Lead process improvements and contribute to cross-asset or cross-tumor working groups.
• Mentor and develop less experienced team members and provide line management as appropriate.

Skills

Oncology experience

Clinical development leadership

Good Clinical Practice (GCP)

Regulatory submissions

Medical monitoring

Education

PharmD

Ph.D. in Life Sciences

MD

Job description

Jobtailor is seeking an experienced clinical development leader with a strong oncology focus to own protocol design and governance. You will lead study-level medical monitoring, regulatory interactions, and cross-functional collaboration across global teams.

The role requires 7+ years in drug development, with a PharmD/PhD/MD and deep experience in GCP, NDA/BLA processes, and complex study designs. This is a high-impact, on-site Maryland opportunity.