AD of Clinical Development Trial Lead

** Associate Director, Clinical Development Trial Lead (CDTL)*
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* Location:

** Stamford, CT (Onsite/Hybrid options)

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** Pay Rate:**  $100.00 - $104.00/hour W-2

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** Assignment Duration:
** 12-18 months (Potential for permanent conversion for local candidates)

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* Employment Type:

** Full-time W-2 Contract (Kelly consultant assigned to a direct sponsor client)

** Position Summary*
* Kelly Science and Clinical is seeking an  
** Associate Director, Clinical Development Trial Lead (CDTL)
** with a strong background in  
** Oncology (early and/or late phase)
** to manage the operational and technical execution of complex clinical trials. The Associate Director, CDTL independently leads cross-functional study teams and holds global/regional accountability for delivering clinical milestones on time, within scope, and on budget. This role requires exceptional independent leadership, strategic risk management, and the ability to influence cross-functional matrix teams, vendors, and business partners. This is a full-time, M-F contract opportunity embedded directly with a premier sponsor client.

** Key Responsibilities*
* ** Project Management & Global/Regional Operations*
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** Trial Execution:
** Utilize advanced project management tools and methodologies to scope, track, and execute local, regional, and global clinical trials.

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** Timeline & Enrollment:
** Develop and track global trial enrollment plans; align inputs across geographies and functions from country allocation through Last Patient Entered Treatment (LPET).

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** Budget &

Risk Management:

** Monitor trial-level budgets (grants, non-grants, and financial assumptions); proactively identify, assess, and mitigate trial-level risks.

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** Vendor & CRO Oversight:
** Serve as the primary clinical development point of contact for fully or partially outsourced trial execution; manage Third-Party Organization (TPO) qualification, selection, and milestone delivery.

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** Cross-Functional Leadership:
** Drive solutions across the broader Therapeutic Area/Molecule level, attending critical chain network builds and providing strategic input.

** Process Leadership & Inspection Readiness*
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** Single Point of Accountability:
** Own the Trial Master File (TMF) for assigned trials, ensuring functional record owners keep documentation current and continuously inspection-ready.

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** Quality & Compliance:
** Apply global/regional regulations, Good Clinical Practice (GCP), and sponsor standards. Independently detect and resolve quality issues, collaborating with Medical Quality, Legal, and Compliance as needed.

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** Process Improvement:
** Act as a Subject Matter Expert (SME) to develop and roll out new tools, methodologies, and continuous improvement activities based on regulatory or industry trends.

** Scientific Consultation*
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** Document & Regulatory Support:
** Leverage scientific and regulatory knowledge to prepare technical documentation, prepare for regulatory agency meetings, and draft responses to TPO or affiliate inquiries.

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** Study Design Input:
** Combine scientific, regional, and operational expertise to positively impact clinical trial design, feasibility, and implementation.

** Qualifications*
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* Education:

** Bachelor's degree required; a scientific or health-related field is highly preferred.

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* Experience:

** Minimum of 5 years leading clinical trials with deep working knowledge of the clinical research process. (10+ years of overall industry experience within clinical research/life sciences preferred).

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* Required:

** Direct experience managing  
** Oncology
* * trials (early and/or late phases).

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** Leadership

Skills:

** Demonstrated ability to influence without authority, navigate complex/ambiguous situations, and manage cross-cultural global teams.

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** Technical Expertise:
** Applied knowledge of project management methodologies and proficiency with industry tools (e.g., Veeva, MS Project, Excel, PowerBI, Critical Chain).

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** Compliance Knowledge:
** Strong familiarity with local/regional country requirements and international GCP guidelines.

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** Travel:
** Ability to travel periodically to scientific or regional meetings as required.

As part…