Senior Director Geography Lead

About this role

Responsibilities

• Strategic Leadership & Geographic Strategy:
• Provide strategic direction within assigned country; ensure consistent execution, quality, and compliance; develop country-specific objectives aligned with organizational priorities.
• Serve on the functional area's leadership team as assigned; represent geographic and functional perspectives in GDMS (Global Data Management & Standards) LT (Leadership Team)/enterprise forums and audits as needed.
• Lead or participate in cross-functional collaborations with non-GDMS partners and enterprise support functions to achieve geographic strategic and operational objectives.
• Communicate clear narratives to executives on risks, trade-offs, and decisions; champion innovation, automation, and risk-based data-management practices; share lessons and maintain quality oversight across geographies.
• Lead the operating model and optimization strategy for the assigned geography, integrating functional area and GDMS global strategic objectives.
• Actively identify and support functional area capability development and implementation aligned with industry best practices and business needs; drive adoption of technology across relevant organizations consistent with agreed-upon principles and organizational priorities.
• Inspire teams toward shared goals for our company's Clinical Development Portfolio, GCTO (Global Clinical Trial Operations) objectives, and cross-functional partners.
• As assigned, serve as the GDMS Site Head for the relevant country
• Partner with Country and Regional business support functions (e.g., HR, Finance) to enable local business priorities.
• Operational Governance, Execution, & Cross-Functional Alignment:
• Coordinate workforce planning, resource management, and operational performance.
• Serve as escalation point for country issues and oversee country-specific risk, escalation, and capacity-management processes; ensure local regulatory, business, and labor compliance.
• Ensure geography/functional inspection readiness and compliant operational controls, including operational data, change management, and system releases.
• Evaluate and implement process/technology improvements that enhance scalability, standardization, and quality; support operating model adoption and change management.
• Lead complex cross-functional workstreams, focus areas to be determined based on needs of the organization from idea/design to implementation and value realization.
• Actively support and participate in metrics governance and performance reviews with Portfolio & Resource Operations Specialists to ensure transparent portfolio health and operational efficiency.
• Actively manage OKRs (Objectives and Key Results) and performance metrics for assigned geography in alignment with broader GDMS goals and priorities; monitor dashboards and drive accountability.
• Conduct enterprise and country scenario planning and implement resilience playbooks to ensure business continuity and protect critical work and service levels.
• Provide concise, decision-ready updates and status reporting to leadership and partners.
• People Management & Talent Development:
• Align teams around a clear direction; set clear objectives aligned to organizational goals; assign work and set priorities accounting for work-life balance sustainability.
• Conduct regular check-ins and annual reviews; coach for performance; provide recognition.
• Develop career plans; create growth opportunities and promotion cases; ensure appropriate training and mentoring.
• Lead recruiting and hiring and oversee performance management activities, including management of sensitive employee-relations matters in partnership with HR.
• Coordinate on-shore/off-shore and contingent resources; ensure role clarity and effective handoffs.
• Manage an operating budget and optimize spend against priorities.
• Inspires and ensures that team leaders are effectively supporting and empowering their individual leaders.
• Capability leadership (as assigned):
• Sit on functional area leadership team as the representative for their assigned capability
• Accountable for defining the strategic objectives and roadmap for capability development initiatives aligned to business needs and industry best practices.
• Establish and oversee capability governance with GDMS / GCTO policies and enterprise digital / data initiatives.
• Own development of critical capabilities (tools, processes, skills) aligned to industry best practices.
• Drive consistent global rollout via playbooks, guidance, and implementation support; align cross-regional ways of working with partners.
• Qualifications & Experience
• Bachelor's Degree in a Life Science, Management or related field with 13 years of experience in clinical trial operations or pharmacovigilance, including 5 years of people management experience or Advanced Degree (Masters or Doctorate) in a Life Science, Management, or related field with 10 years of experience in clinical trial operations or pharmacovigilance, including 5 years of people management experience
• Technical Skills
• Fluent in English language capabilities, with exceptional written and verbal communication for technical and business audiences.
• Strong understanding of end-to-end data management processes and systems used for data collection, application of data standards, cleaning/review, reporting, governance, and use of operational and quality metrics to monitor performance.
• Deep knowledge of ICH/GCP (International Council of Harmonization - Good Clinical Practices) guidelines and how they apply to clinical or safety data management activities.
• Understanding of regulatory requirements, quality frameworks, and inspection/audit processes; ability to support inspection/audit readiness.
• Proven experience implementing risk-based and digital data practices, using data and automation to improve focus and quality.
• Knowledge of geographic risk, escalation, and capacity management processes.
• Ability to use analytical and forecasting tools (dashboards, capacity models) to inform resourcing, planning, and operational decisions.
• Ability to define and enforce standards for integration, reuse, and scalability of data, tools, and solutions.
• Proven financial stewardship, including budget ownership, workforce cost modeling, and development of investment/value realization frameworks.
• Knowledge of local-subsidiary operations (HR, vendors, facilities, finance) and local compliance expectations.
• Expertise in data-product governance (definitions, lineage, quality controls, lifecycle) to maintain a global single source of truth.
• Safety Data Management-specific Technical Skills:
• Strong understanding of end-to-end safety data management across collection, review, governance, reporting, and associated operational/quality metrics.
• Deep knowledge of pharmacovigilance (PV) regulations and how they apply to safety data management.
• Demonstrated expertise in vendor strategy, including SLA/SOW (Service Level Agreement/ Statement of Work) development, performance scorecard design, and contract risk management.
• Non-technical knowledge, skills, and abilities
• Strategic leadership with the ability to align diverse, cross-functional, and virtual teams and stakeholders around shared objectives.
• Strong ability in negotiation and conflict resolution; aligning divergent priorities to enterprise outcomes and enforces clear responsibilities.
• Effective facilitation of decision-making, coordinating work across teams and driving timely resolution of complex issues.
• Change leadership, including executive influence and storytelling to shape decisions across senior leadership levels; ability to communicate with both the technical and business areas.
• Demonstrated ability to drive large-scale change, embed innovation, and lead continuous improvement initiatives, while ensuring adoption of standardized, risk-based, and digital practices.
• Strong people leadership, mentoring, and development capabilities across multiple levels and geography; create a high-performance, inclusive culture that attracts, develops, and retains talent.
• Ability to integrate business, operational, and people dimensions into effective decision-making; demonstrated budget and business acumen.
• Highly adaptable and resilient, able to prioritize and perform effectively under pressure.
• Demonstrated disciplined prioritization focused on critical metrics and initiatives.
• Works independently with sound judgment, exercising initiative while maintaining alignment with organizational priorities.
• Tailors messaging up, across, and down with clear, actionable feedback to direct reports.
• Capability building focused on senior-level talent development and communities of practice.
• Enterprise Leadership Skills
• Talent Growth | Build and sustain organizational talent for the geography by establishing systems to attract, develop, engage, and retain top performers, and by fostering an environment where people can realize their full potential to meet current and future business needs.
• Strategic Planning | Thinks strategically and gains alignment through collaborative stakeholder engagement and influence across development, clinical operations, regulatory, safety, and IT.
• Networking & Partnerships | Proactively builds and sustains strategic internal and external relationships (cross‑functional leaders, service providers, alliance partners, customers) to accelerate functional area and geography-specific objectives.
• Required Skills:
• Adaptability, Adaptability, Budget Management, Business Continuity, Change Management, Clinical Data Management, Clinical Study Management, Clinical Study Protocols, Cross-Functional Alignment, Data Analysis, Data Governance, Data Processing, Data Validation, Decision Making, Ethical Standards, Good Clinical Practice (GCP), Labor Compliance, Operating Models, Operational Control, Organizational Effectiveness, People Leadership, Recruiting Processes, Strategic Thinking, Talent Development, Talent Management {+ 2 more}
• Preferred Skills:
• Current Employees apply
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• Current Contingent Workers apply
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• Search Firm Representatives Please Read Carefully
• Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
• Employee Status:
• Regular