Clinical Development Trial Lead (CDTL
Listed on 2026-08-05
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Management
Regulatory Compliance Specialist
Clinical Development Trial Leads (CDTLs)
Client is seeking experienced Clinical Development Trial Leads (CDTLs) to support global oncology clinical trials across both early and late-stage development programs. The majority of openings are focused on Early Phase Oncology, with 1-2 positions supporting Late Phase studies. The CDTL will function as an independent study leader responsible for end-to-end clinical trial management and operational execution of global oncology studies involving solid tumor indications.
This role requires strong leadership, cross-functional collaboration, vendor oversight, and project management capabilities.
Therapeutic Area:
Oncology
Solid Tumor Indications
Study Phase:
Majority Early Phase (Phase I Oncology), Limited Late Phase opportunities
Geographic Scope:
Global clinical trials conducted across North America, Europe, APAC
Travel Requirements:
Less than 10% travel, occasional travel to Ireland may be required
Key Responsibilities:
- Lead end-to-end clinical trial management activities from study start-up through closeout.
- Independently manage complex global oncology studies.
- Partner closely with Program Leads and cross-functional teams to ensure successful study execution.
- Oversee and drive CRO performance, ensuring accountability for study deliverables, timelines, and quality.
- Manage external vendors and strategic partners involved in study execution.
- Lead and participate in Study Management Team meetings.
- Collaborate with Data Management, Clinical Operations, Regulatory Affairs, Medical, Safety, and other functional teams.
- Monitor study progress, identify operational risks, and drive mitigation strategies.
- Support both development and post-marketing clinical trial activities where applicable.
- Ensure studies are conducted in compliance with GCP, regulatory requirements, and company standards.
Required Qualifications:
- Minimum 5 years of direct Oncology clinical trial experience.
- Strong experience in end-to-end Study Management.
- Experience leading global clinical trials across multiple regions.
- Proven ability to work independently with minimal supervision.
- Experience managing CROs, vendors, and external partners.
- Strong cross-functional leadership and stakeholder management skills.
- Solid project management experience.
- Experience supporting study start-up, study conduct, data management activities, and study closeout.
Preferred Qualifications:
- 10 years of Oncology clinical development experience.
- Significant experience in Early Phase Oncology (Phase I studies).
- Experience with Solid Tumor programs.
- Background within both Big Pharma and CRO environments.
- Experience operating at the Senior Manager or Associate Director level.
- Ability to manage highly complex global studies and influence stakeholders across functions.
Team Environment:
- Approximately 30 professionals within the Early Phase Oncology group.
- Highly collaborative yet independent working environment.
- Candidate will serve as a key operational leader with significant ownership and accountability.
- Frequent interaction with Program Leads, CRO Project Managers, and cross-functional stakeholders.
Interview Process:
Round 1:
Panel Interview (90-120 minutes)
- Both of the Early Phase managers and Late Phase Managers
- Additional member(s) of the management team
Final Round:
Leadership Interview (90-120 minutes)
- VP
- AVP
- Candidates who successfully clear the panel interview will advance to the leadership discussion.
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