Clinical Development Trial Lead (CDTL)

Openings & Locations

• 4-5 total openings
• 3 positions based in Indianapolis, IN
• 2 positions based in Stamford, CT
• Preference for candidates who can work onsite at either location
• Strong remote candidates may be considered, particularly those with significant Big Pharma experience

Position Overview

• 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.