Associate Director – Clinical Sciences | Novartis (Hyderabad, India)
Job Summary:
Novartis is seeking an experienced Associate Director, Clinical Sciences to lead clinical operations for multiple research programs including IITs, RCs, and NIS/LIS. This full-time, Hybrid role is based in Hyderabad, and involves overseeing a clinical team, ensuring compliance with GCP, FDA, SOPs, and supporting regulatory submissions. The ideal candidate brings 8+ years of experience in clinical research with proven leadership in global clinical trial execution.
Key Responsibilities:
Lead a team of 6 clinical sciences professionals, reporting to the Director, Clinical Sciences HYD
Oversee trial data accuracy and timely updates in all tracking systems
Facilitate reviews such as MRC and SRC for study concepts and plans
Coordinate clinical trial documentation including CVs, protocols, ICFs, and ethics approvals
Ensure consistent TMF and TPSR documentation and version control
Support charter creation and scientific council (SC) and executive oversight (EO) meetings
Manage internal and external alignment for RCs including EPRM and TPIAT completion
Oversee drug supply coordination with Local Clinical Supply Manager
Contribute to regulatory submissions, clinical reports, and IND documentation
Track and reconcile trial budgets and coordinate financial closure activities
Participate in quarterly reviews with Therapeutic Area teams
Promote continuous compliance with SOPs, GCPs, and internal quality standards
Act as liaison between global (US/MXC) and local (HYD) clinical science teams
Required Skills & Qualifications:
Bachelor's degree in a science field or equivalent (nursing certification also acceptable)
Minimum 8 years of clinical research/monitoring experience in pharma or CRO
Deep knowledge of FDA regulations, GCP, and clinical SOPs
Prior experience mentoring clinical teams or associates
Strong medical data evaluation and medical terminology understanding
Excellent communication, leadership, and problem-solving skills
Advanced Microsoft Office proficiency and comfort with clinical systems
Organizational agility with ability to manage complex, cross-functional environments
Flexible, self-directed professional with strong interpersonal skills
Perks & Benefits:
Global exposure with a leading pharmaceutical company
Collaborative hybrid work environment (Hyderabad-based)
Structured career development and learning programs
Competitive salary package (not specified)
Full access to the Novartis Benefits & Rewards program
Inclusive, purpose-driven culture focused on patient outcomes
Company Description:
Novartis Healthcare Pvt. Ltd. is a globally recognized leader in life sciences and pharmaceuticals, committed to reimagining medicine to improve and extend lives. With cutting-edge innovation and a people-first culture, Novartis empowers healthcare professionals to shape the future of medicine.
Work Mode:
Hybrid – Hyderabad, India
Call-to-Action:
Are you ready to lead clinical operations that drive transformative therapies forward? Apply now to join Novartis as an Associate Director, Clinical Sciences and help reimagine medicine for millions.
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