Director, Medical Evidence Generation Operations Lead (Multiple Openings)

The Director MEG Ops Lead is accountable for the operational strategy, resourcing, and performance of all studies within their therapeutic area, partnering closely with MEG Operations, MEG and cross-functional teams to ensure alignment with business objectives, regulatory standards, and quality benchmarks. This role drives consistent operational excellence and standardization across the portfolio, builds a strong bench of operational talent, and represents MEG Operations in cross-functional and governance forums.

This role may also lead global initiatives, support hiring and resource planning for the therapeutic area, mentor future leaders, and contribute to organizational strategy and continuous improvement across MEG Operations.

The Director MEG Operations Lead plays a pivotal part in driving delivery of medical studies, with broad impact across the therapeutic area and global teams.

Note: This role is a therapeutic-area-aligned people leader with direct reports; the therapeutic area assignment and reporting team size vary by portfolio and hiring stage.

Duties/Responsibilities

Responsibilities involve a combination of people leadership, TA-level oversight, and hands-on operational guidance, and may include, but are not limited to, the following:

Team Leadership & People Management

• 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.

TA Portfolio & Program Oversight

• 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.

Study Input & Strategic Guidance

• 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.

Budgeting & Resource Planning

• 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.

Program & Study Oversight

• 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).

Project Management

• 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.

Management Competencies

• 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.