• Partner with executive leadership to develop annual business plans, revenue targets, and service line roadmap • Support business development to identify, pursue, and close new business opportunities including new client relationships, expanded scopes of work, and strategic partnerships • Own Profit & Loss (P&L) accountability for the divisions TMF Services practice, driving profitability through efficient delivery models and pricing strategy • Continuously evaluate and implement best-in-class tools and workflows for eTMF management, TMF record quality, and inspection readiness • Establish scalable delivery frameworks and quality standards across client engagements • Monitor industry trends (regulatory guidance, technology evolution, competitive landscape) and translate insights into service improvements • Revise, implement and monitor departmental compliance with SOPs • Champion the adoption of AI technologies, automation, and digital tools to enhance team productivity and client outcomes • Serve as an executive sponsor for key client accounts, ensuring high levels of satisfaction, retention, and growth • Oversee the successful delivery of the TMF Services portfolio, ensuring projects meet quality, timeline, budget, and compliance objectives • Build trusted advisor relationships with client stakeholders at the director and C-suite level • Ensure team members meet departmental and project productivity and quality metrics by efficient execution of their project in line with project plan • Serve as a visible spokesperson and subject matter expert for the company in the eTMF and clinical operations space • Represent the organization as a thought leader and subject matter expert through industry conferences, publications, webinars, and professional networks • Build and maintain a strong external network with sponsors, CROs, technology vendors, and industry associations • Recruit, develop, and lead a high-performing team while fostering a culture of accountability, collaboration, and continuous improvement • Collaborate cross-functionally with commercial, technology, and operational teams to achieve strategic business objectives • Complete all other tasks deemed appropriate for the role as assigned by the manager/supervisor

• Provide strategic and scientific leadership for process validation (PPQ, CPV, lifecycle validation) across commercial programs. • Lead and facilitate execution of validation strategies to support technology transfer, site readiness, and product launch. • Ensure alignment of validation activities with regulatory expectations and lifecycle management plans. • Develop and implement risk management frameworks, tools, and processes in collaboration with Quality. • Lead cross-functional risk assessments to identify, evaluate, and mitigate operational, technical, and regulatory risks. • Monitor and communicate risk trends and key risk indicators to stakeholders. • Support commercial manufacturing operations by ensuring processes remain in a validated and controlled state. • Contribute to lifecycle management activities, including process improvements and continued process verification. • Collaborate with Regulatory, CMC, Quality, Supply Chain, Procurement, and Engineering to support commercialization and supply continuity. • Partner with internal teams and external CMOs to ensure alignment on validation and risk strategies. • Provide guidance for validation of processes, systems, facilities, and methods within the commercial organization. • Support deviation investigations, ensuring timely resolution and sustained compliance. • Contribute to authoring and reviewing regulatory filings and responses to health authorities. • Effectively communicate the scientific and commercial rationale for validation and risk management strategies. • Provide leadership for execution of process validation and comparability activities, ensuring data integrity and compliance. • Provide guidance on raw material qualification strategies to ensure supply reliability. • Support validation activities across internal and external manufacturing networks. • Communicate process validation performance and risk insights to key stakeholders. • Build strong working relationships and influence across a matrixed organization. • Contribute as a key member of the Global MSAT organization to enable successful commercialization.

• As Managing Director, you'll help create the conditions for Awana Digital's people and programs to thrive. • Working closely with the Executive Director and leadership team, you'll help strengthen the organization's effectiveness by ensuring that our people, resources, systems, and priorities are aligned in support of our mission. • Key areas of responsibility include: - Supporting and developing staff while fostering a culture of trust, accountability, learning, and collaboration. - Creating clarity around priorities, goals, roles, and expectations across the organization. - Strengthening communication, coordination, and relationships across teams. - Designing and improving systems, workflows, and processes that help the organization operate effectively. - Supporting organizational planning, decision-making, and implementation of strategic priorities. - Aligning budgets, staffing, projects, and funder commitments with organizational goals. - Building structures that help teams navigate growth, change, and new opportunities. - Identifying challenges, solving problems, and helping move important work forward.

• Create and execute a business strategy and execution plan for assigned commercial/federal/state government payer markets with an objective to minimize access barriers through streamlined and transparent coverage resulting in smooth patient access to therapy • Drive education in coordination with commercial leadership and other Value & Access team members regarding commercial/federal/state marketplace activities and make recommendations for their pull through success in this marketplace to maximize appropriate use • Execute and support any necessary commercial/government contracts as necessary to optimize reimbursement /product access • Responsible for staying current with the evolution of trends and policies related to the commercial/federal/state government access markets • Create and update business strategies and plans as needed • Facilitate communication about this segment across all relevant stakeholders • Establish critical relationships with a variety of stakeholders within this segment • Establish Zydus Therapeutics as a strategic partner for commercial, federal and state customers • Reactively respond to any identified coverage issues and market access challenges within a given payer segment • Lead and demonstrate the ability to expand or build long-term executive level account relationships with targeted accounts • Collaborate with brand and medical teams to continually improve relationships • Attend key trade meetings (ex. PCMA, AMCP), POA’s and sales meetings • Develop internal triage process in collaboration with field leadership around coverage concerns including denials or appeals and a plan to remediate