Clinical Development Trial Lead (CDTL)

Mindlance

  • Indianapolis, IN
  • 30+ days ago

    Highlights

    Client is seeking experienced Clinical Development Trial Leads (CDTLs) to support global oncology clinical trials across both early and late-stage development programs. 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.

    Numbers & Facts

    LocationIndianapolis, IN

    Description

    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.

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