Senior Director Global Development Solutions

Job description

**Role & responsibilities** **Culture & Talent Leadership :** Accountable for the organizational design of the Global Development, Digitial and Technology function in GCC. Establishes and sustains a high-performance, inclusive team culture across the India-based Global Development Digital & Technology (GD D&T) organization; leads with intentionality to attract, develop, and retain top-tier technology talent, while embedding shared values of accountability, innovation, and continuous improvement that align with and reinforce the broader operating principles. **Global Development Domain Expertise:** Possesses deep, demonstrable knowledge of pharmaceutical and biotech drug development processes spanning Clinical Operations, Bio-Stats & Data Management, Regulatory, Quality, Medical Affairs, Safety and translates that domain fluency into technology strategies, system designs, and delivery frameworks that directly accelerate development program objectives at a global scale. **Technology and Data Expertise**: Lead end to end delivery across all applicable teams (e.g., architecture, technology and data) and roles in both traditional waterfall and agile models **Global-Local Integration & Operational Excellence:** Stand up and ensure the India GCC GD D&T organization functions as a fully integrated, co-accountable partner within the global delivery model — not a service satellite, but a strategic node; drives operational discipline, delivery predictability, and continuous process improvement. Build out includes recruiting, onboarding, operationalizing and expanding new GD D&T capabilities within the India GCC. **Validation & Compliance Excellence:** Serves as the site authority for computer system validation (CSV/CSVa), GxP compliance, and data integrity governance; designs and oversees inspection-ready validation programs aligned with ICH guidelines, 21 CFR Part 11, Annex 11, and evolving regulatory expectations, ensuring the organization maintains a continuous state of audit readiness across all development-facing systems. **Strategic Contribution & Business Alignment:** Serves as a strategic partner to the GD D&T leadership team; brings structured thinking, sound business judgment, and a forward-looking technology perspective to planning cycles, investment decisions, and organizational design — with the ability to translate ambiguous business challenges into clear, executable IT strategies. **Executive Communication & Stakeholder Engagement:** Communicates with executive presence and precision across a globally distributed stakeholder landscape — including US-based senior leadership, regional business partners, and cross-functional peers; demonstrates the ability to distill complex technical and regulatory topics into concise, credible narratives appropriate for executive-level, regulatory, and operational audiences. **Domain & Industry Knowledge** - Deep, demonstrable knowledge of pharmaceutical/biotech drug development across Clinical Operations, Biostatistics & Data Management, Regulatory, Quality, Medical Affairs, and Drug Safety/Pharmacovigilance. - Demonstrated ability to evaluate, adopt, and govern AI/GenAI capabilities within GxP-regulated environments—translating emerging AI technologies into practical, compliant, and value-generating solutions across the drug development lifecycle. - Working knowledge of the systems landscape supporting these functions (e.g., CTMS, EDC, RIM/regulatory submission platforms, safety/PV systems, statistical computing environments, clinical data repositories). - Strong command of GxP compliance, computer system validation (CSV/CSVa), and data integrity (ALCOA+) principles. - Practical knowledge of applicable regulations and guidance, including 21 CFR Part 11, EU Annex 11, and ICH guidelines, plus an awareness of evolving regulatory expectations. **Technical & Delivery Skills** - Proven ability to lead end-to-end delivery across architecture, engineering/technology, and data & AI teams. - Ability to translate business and scientific objectives into coherent technology strategies, system designs, and delivery frameworks. - Skill in establishing delivery predictability, operational metrics, and continuous process improvement practices.