Director, Medical Evidence Generation Operations Lead (Multiple Openings)

Duties/Responsibilities

• Serves as the direct line manager for Global Trial Leads within the assigned TA, including hiring, onboarding, workload allocation, performance management, and career development.
• Balances resourcing and workload across the therapeutic area's trial portfolio, proactively identifying and resolving capacity gaps.
• Fosters an inclusive, high-performing team culture that promotes collaboration, accountability, and resilience.
• Champions ongoing training, professional development, and knowledge-sharing across the team.
• Sets performance objectives, conducts regular one-on-ones, and delivers timely, constructive feedback and formal performance reviews for direct reports.
• Provides operational oversight across all medical trials within the assigned TA portfolio, ensuring consistent delivery standards, quality, and regulatory compliance.
• Serves as the primary point of escalation for TA-level operational issues, partnering with MEG Ops, MEG and cross-functional teams to proactively address, mitigate and resolve complex risks and cross-study dependencies.
• Aggregates and reports on portfolio-level performance metrics, budget status, and risk indicators to senior MEG Operations leadership.
• Identifies cross-study synergies and drives standardization of best practices and operational tools across the TA.
• Partners with the MEG Ops, MEG and cross-functional teams to align resourcing, systems, and reporting across MEG Operations.
• Provide operational leadership and representation within medical governance forums, ensuring study endorsement decisions are informed by feasibility assessments, resource considerations, operational risks, and organizational priorities.
• Identifies and proactively manages TA-level risks, balancing trade-offs between cost, deliverables, and quality.
• Offers therapeutic and operational guidance on study protocols and execution strategies across the assigned portfolio.
• Provides consultation across programs/studies with a focus on risk mitigation and operational excellence.
• Monitors trends in MEG Operations and advises teams and leadership on proactive responses.
• Supports MEG Ops, MEG and cross-functional teams, including senior leadership, on asset, trial, and/or inquiries.
• Drives upfront planning of study timelines and budgets across the therapeutic area in partnership with cross-functional teams and Finance.
• Leads quarterly budget reviews for the portfolio, flagging anticipated variances and collaborating with Finance on forecasting.
• Identifies and resolves issues impacting budget and timeline adherence across assigned studies.
• Oversees TA-level vendor logistics and escalates resourcing needs appropriately.
• Oversees strategic planning and execution of multiple medical trials across the TA, ensuring timely and high-quality deliverables.
• Provides lifecycle leadership and oversight from start-up to close-out phases across the portfolio.
• Leads, supports and coordinates between cross-functional study teams.
• Analyzes operational metrics to optimize study execution and ensure alignment with franchise objectives.
• Identifies organizational and procedural challenges across the therapeutic area, proposing actionable solutions.
• Builds and maintains strategic partnerships with internal stakeholders (e.g., Medical/Clinical Research, Affiliates) and external collaborators (e.g., CROs, AROs).
• Oversees collaboration between internal cross-functional teams and vendors to ensure medical trial delivery across the therapeutic area meets established timelines, budgets, and quality benchmarks.
• Provides strategic input on study feasibility and oversees operational activities of internal and external contributors across the portfolio.
• Supports scope of work (SOW) for CROs and Vendor Partners across assigned studies, ensuring alignment with contractual terms, budgetary targets, and quality standards.
• Supports vendor selection and evaluation processes and oversees vendor and partner relationships at a TA-level.
• Supports and provides approval (when needed) for vendor invoices, accruals, and scope amendments as needed for escalated or high-value items.
• Oversees that accurate data records are maintained across study management systems such as Veeva (i.e., CTMS, eTMF, etc.).
• Develops and enforces trial-specific standards aligned with broader portfolio strategies to promote operational consistency.
• Leads development and execution of cross-functional and global best practices.

Education and Experience Requirements

• BA/BS or equivalent degree in relevant discipline required; advanced degree (MS, PharmD, PhD, MD, or equivalent) preferred.
• Minimum 9 years of experience in clinical/medical operations and project management in the pharmaceutical or healthcare industry, including multi-national experience.
• Prior direct people management experience required, including hiring, coaching, and performance management of operational staff.
• Experience in independently leading complex global clinical/medical trials, demonstrating strong knowledge of study and program strategy.
• Experience leading global and multi-functional teams in a matrixed environment.
• Experience in managing CROs and external partners preferred.
• Travel requirement: up to 25%.

Key Competencies

• Global Trial & Portfolio Management: Leads a TA portfolio of global medical trials with expertise in planning, execution, and oversight. Ensures regulatory compliance, patient safety, and timely delivery of high-quality data. Drives portfolio outcomes through strategic coordination, resourcing, and progress tracking.
• Operational & Budget Oversight: Oversees end-to-end trial operations across a portfolio of studies, including but not limited to site selection, recruitment, vendor coordination, and resource planning. Oversees budgets, forecasts, accruals, and cost optimization to ensure financial accuracy and efficiency.
• Risk & Quality Management: Identifies and mitigates risks across the portfolio to ensure trial continuity. Maintains GCP/GXP compliance and supports audit readiness with a strong quality mindset.
• Stakeholder & Vendor Engagement: Builds strong relationships with internal and external stakeholders. Manages communications, escalations, and alignment across functions and geographies.
• Medical & Regulatory Expertise: Demonstrates deep knowledge of research trial phases, TAs, and regulatory requirements. Ensures readiness for submissions and compliance with global standards.
• Systems & Data Management: Utilizes CTMS and other systems to track milestones, ensure data quality, and support decision-making across the portfolio. Partners with technical teams to maintain system integrity.
• People Leadership & Talent Development: Directly manages, coaches, and develops a team of GTLs, and may be a player-coach to reinforce best practices in study execution and trial management. Sets clear expectations, delivers regular feedback, and builds bench strength and succession plans within the therapeutic area.
• Leadership & Collaboration: Drives cross-functional teams toward shared goals. Builds consensus and fosters an inclusive, high-performing culture across the therapeutic area team.
• Critical Thinking & Decision Making: Solves complex problems and makes timely, informed decisions that prioritize patient safety and data integrity.
• Accountability & Results Focus: Owns portfolio and team outcomes, ensures quality, and delivers on time and within budget through proactive oversight.
• Adaptability & Resilience: Responds effectively to change and manages conflict constructively while maintaining team morale.
• Communication & Relationship Building: Communicates clearly across global teams and builds strong, trust-based relationships with diverse stakeholders.