Associate Director, Clinical Development Trial Lead (CDTL)

Position Overview: The Associate Director, Clinical Development Trial Lead (CDTL), will independently lead cross-functional study teams in the development and execution of complex clinical trials. This role is accountable for delivering clinical milestones regionally and globally with quality, on time, and within scope and budget. The CDTL provides independent leadership, influences study teams, management, and business partners, and proactively identifies and resolves issues affecting trial delivery. Key Responsibilities1. Clinical Trial Leadership and Execution Lead, influence, and project-manage large, complex clinical studies and/or multiple smaller studies. Drive local, regional, and global cross-functional study teams through trial implementation, execution, and closure. Ensure clinical trial deliverables are achieved through proactive issue management, contingency planning, and issue resolution. Monitor trial scope and implement adjustments through the established change control process. Develop and track global trial enrollment plans by aligning inputs across functions and geographies. Provide consultation and guidance to CDTLs on integrated trial plans. Manage trial-level risks, identify operational challenges, and implement solutions with minimal management support. Drive enrollment strategy and execution at the trial, regional, program, and molecule levels, from country allocation through Last Patient Entered Treatment (LPET).Partner with Regional Operations to achieve regional enrollment goals. Coordinate and participate in Investigator Study Specific Training (ISSTs) and Affiliate Study Training (ASTs).Contribute to therapeutic area, molecule, and indication-level activities, including critical chain network builds and strategy development.2. Project Management, Budget, and Risk Management Apply project management methodologies, processes, and tools to plan, execute, and monitor clinical trials. Understand trial-level scope, timelines, deliverables, and cross-functional budget components. Create and monitor grant and non-grant budgets, including underlying assumptions, using financial tracking tools. Routinely collaborate with business partners regarding trial budget status and changes. Serve as a point of contact for other CDTLs on clinical trial budget-related matters as needed. Anticipate and resolve complex operational and business challenges involving vendors, affiliates, regional teams, global colleagues, and other business partners. Evaluate issues requiring escalation and make timely decisions in ambiguous or complex situations. Identify opportunities for continuous improvement based on industry trends, regulatory developments, and emerging technologies.3. Regional Operations and Cross-Functional Collaboration Apply knowledge of global and regional operating models and coordinate regional input for study teams. Leverage regional, scientific, therapeutic, and operational expertise to support clinical trial design, feasibility, and implementation. Understand regional and local regulatory requirements by liaising with affiliates and other appropriate resources. Demonstrate effective collaboration with global colleagues, regional teams, and third-party organizations (TPOs).Lead cross-functional teams, influence stakeholders without direct authority, and maintain effective working relationships. Support regional clinical operational processes and methodologies. Manage TPO qualification, selection, and oversight. Serve as the clinical development point of contact for outsourced and fully outsourced trial execution through Clinical Research Organizations (CROs).Ensure CRO delivery of project milestones.4. Trial Master File, Quality, and Inspection Readiness Serve as the single point of accountability for the Trial Master File (TMF) for assigned trials. Work closely with functional record owners to ensure the TMF remains current and inspection-ready. Ensure inspection readiness for assigned clinical trials. Ensure timely documentation of deviations and the development of storyboards or issue summary documents for high-risk areas and key topics. Identify process breakdowns, analyze situations, anticipate regional and trial-level issues, and propose solutions to mitigate risks. Independently identify and resolve quality issues, escalating to functional leadership or consulting Medical Quality, Legal, Compliance, and other functions when appropriate. Apply knowledge of global and regional regulations, Good Clinical Practice (GCP), and company standards of operation in clinical trial conduct. Ensure accurate and complete clinical trial information across multiple business systems and tools.5. Scientific and Regulatory Expertise Apply scientific, therapeutic, and regulatory knowledge to support clinical trial planning and execution. Prepare or provide technical consultation on clinical and regulatory documents. Support preparation for regulatory agency meetings and draft responses to questions from regulatory agencies, TPOs, and affiliates. Use clinical development knowledge, problem-solving, and critical-thinking skills to address scientific and operational business needs. Serve as a point of contact for therapeutic area and/or disease-state expertise within the clinical team. Leverage scientific, regional, and operational knowledge to influence clinical trial design and implementation.6. Coaching, Leadership, and Process Improvement Coach peers, new CDTLs, cross-functional team members, and TPOs on clinical trial processes and regional requirements. Serve as a subject matter expert (SME) for CDTL peers. Support the development and rollout of new tools, processes, and methodologies. Lead process improvement initiatives and share learnings across functional teams, regions, and external partners. Help others navigate organizational changes, shifting priorities, and complex situations. Demonstrate flexibility, independent judgment, and effective leadership in a dynamic clinical development environment.