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Associate Director, Clinical Sciences

8+ years
Not Disclosed
10 July 1, 2025
Job Description
Job Type: Hybrid Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

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.