Senior Director Global Development Solutions

Randstad; Hyderabad; On-site; INR 3,500,000 - 7,000,000; Full time

Job summary

Randstad in India seeks a senior leader to design and sustain the Global Development, Digital & Technology function across the GCC in India. You will drive organizational design, recruit and develop a high-performance team, and align technology strategies with global development objectives, including regulatory and quality expectations.

You will lead end-to-end delivery across architecture, engineering and data teams in both waterfall and agile models, fostering a culture of accountability,

Qualifications

• Deep knowledge of pharmaceutical/biotech drug development processes (Clinical Operations, Biostatistics & Data Management, Regulatory, Quality, Medical Affairs, Safety)
• Experience implementing AI/GenAI in GxP/regulatory contexts
• Ability to lead cross-functional teams across architecture, engineering, and data & AI

Responsibilities

• Define and drive organizational design for Global Development, Digital & Technology in India GCC
• Lead end-to-end delivery across teams in both waterfall and agile models
• Ensure site acts as a strategic partner within global delivery model and drives continuous process improvement
• Oversee CSV/CSVa, 21 CFR Part 11, Annex 11 alignment and audit readiness
• Engage with executive stakeholders and translate complex topics into clear IT strategies

Skills

Leadership

Strategic planning

Regulatory knowledge

Executive communication

GxP/compliance

Education

Bachelor's degree in Life Sciences or related field

MBA or equivalent (preferred)

Tools

CTMS

EDC

RIM

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.