Capgemini - Business Lead - Digital Transformation - Pharma Domain (15-22 yrs)

Job Description : Pharma SI Business Leader/ Pharma Digital Transformation Lead

Position Overview :

- We are seeking a seasoned Pharma Leader with a deep understanding of the pharmaceutical domain, particularly in clinical, medical affairs, and regulatory affairs, to lead and expand our pharma business line. The ideal candidate will have extensive IT experience in the pharma/biotech industry and a proven track record of working with and integrating pharma specific systems. The role will involve driving strategic growth for key accounts and contributing to clinical R&D areas.

Location : Hyderabad only

Key Responsibilities:

Strategic Leadership:

- Lead the expansion of the pharma business line, focusing on IT and consulting services in clinical R&D areas.

- Develop and execute strategies to identify and leverage growth opportunities within the pharmaceutical and biotech sectors.

- Build and maintain strong relationships with key stakeholders, including client leadership teams.

Technical Expertise:

- Provide subject matter expertise on IT systems used across the pharma lifecycle, including pre-clinical research, quality, manufacturing, clinical trials, and pharmacovigilance.

- Lead the integration and optimization of pharma-specific systems such as:

- Veeva Suite.

- Oracle Suite: Argus, Empirica.

- IQVIA Suite.

- Dassault Clinical Suite: Medidata Rave.

Compliance and Best Practices:

- Ensure adherence to regulatory & GxP guidelines, including GAMP, GMP, and GCP.

- Conduct gap analyses to align systems with client SOPs, WPs, and regulatory requirements.

- Provide leadership in developing and implementing technical solutions, ensuring compliance with industry standards and best practices.

Project Management and Delivery:

- Oversee the delivery of complex technical solutions, ensuring alignment with client expectations and regulatory requirements.

- Collaborate with architects, developers, and cross-functional teams to estimate project impacts and ensure seamless integration.

- Create and gain stakeholder agreement on top-level solution documentation, including presentations and system architecture/design documents.

Innovation and Thought Leadership:

- Stay updated on current pharma/biotech industry techniques, conventions, and emerging trends, especially in areas such as Digital R&D, Digital Clinical Trials, DTx, and Data & Gen AI-driven innovations.

- Identify opportunities for innovation and continuous improvement within existing pharma systems and processes.

- Share best practices and technical expertise across teams to enhance overall organizational knowledge.

Qualifications and Experience:

Must-Have:

- Overall Experience: 15+ years in IT/Pharma/Biotech sectors.

- Pharma IT Expertise: 15+ years of experience working with pharma-specific systems and processes.

- Strong knowledge of pharma systems used during:

- Pre-clinical research.

- Quality assurance and manufacturing.

- Clinical trials and pharmacovigilance.

- Medical & Regulatory Affairs.

- Demonstrable experience in systems engineering and integration.

- Expertise in regulatory compliance, including ICH, GxP, and GCP guidelines.

Nice to Have:

- Experience conducting gap analyses to align applications with customer requirements.

- Strong problem-solving and risk mitigation skills in technical project delivery.

- Proficiency in creating solution documentation, including system architecture/design documents.

Soft Skills:

- Exceptional communication and interpersonal skills to engage with clients and cross-functional teams effectively.

- Strategic mindset with the ability to think critically and align technical solutions with business goals.

- Proactive and organized, with strong decision-making abilities and attention to detail.

- Confidence in leading diverse teams and managing high-stakes projects.

Why Join Us?

- Opportunity to work on cutting-edge Digital & GenAI based solutions in the pharma/biotech industry.

- Influence the growth and success of a dedicated pharma business line.

- Collaborate with top-tier global pharma clients and industry leaders.

- Be part of a forward-thinking and innovative team committed to excellence.