Associate Director, Translational Medicine Expert, TM Clinical Pharmacology

Job Description Summary

As Associate Director, Translational Medicine Expert (TME), Clinical Pharmacology (CP TME), you will serve as the primary medical and scientific leader for FiH and Clinical Pharmacology studies. You will partner closely with cross functional Clinical Pharmacology Trial Teams, project level TMEs, and CRO collaborators to ensure the highest standards of medical supervision, participant safety, and scientific quality.
TM Clinical Pharmacology is a cross‑functional expert group responsible for the design, execution, and reporting of First‑in‑Human (FiH) and Clinical Pharmacology studies across all therapeutic areas. Operating through a strategic outsourcing model, we partner with qualified CROs while maintaining strong sponsor oversight of all strategic elements, including study design, regulatory engagement, and timelines.

Location: Hyderabad

 

Job Description

Role Overview

As a Associate Director, Translational Medicine Expert (TME), Clinical Pharmacology (CP TME), you will serve as the primary medical and scientific leader for FiH and Clinical Pharmacology studies. You will partner closely with cross‑functional Clinical Pharmacology Trial Teams, project‑level TMEs, and CRO collaborators to ensure the highest standards of medical supervision, participant safety, and scientific quality.

This role directly shapes early and full development programs across the BR portfolio and plays a critical part in delivering high‑quality data that informs program decisions and regulatory submissions.

Your Responsibilities

1.     Clinical Pharmacology Portfolio Leadership

·        Lead and manage multiple FiH and Clinical Pharmacology studies simultaneously with medical, scientific, and operational excellence

·        Provide expert Clinical Pharmacology input into Study Concept Sheets, protocols, Informed Consent Forms, Statistical Analysis Plans, and TLF shells

·        Oversee medical and safety aspects of studies, including Site Initiation Visits, ongoing safety reviews, medical coding, and safety reporting

·        Drive development of Clinical Study Reports and contribute to dissemination of study results (e.g., abstracts, posters, manuscripts, plain‑language and technical summaries)

2.     Clinical Pharmacology Strategy & Cross‑Functional Collaboration

·        Provide strategic Clinical Pharmacology guidance to ensure optimal study design aligned with program objectives

·        Partner with project‑level TMEs to align on compound background and program strategy

·        Lead or contribute to strategic initiatives, process optimization, and capability‑building efforts within TM Clinical Pharmacology

·        Strengthen collaborations with internal stakeholders across early and full development, as well as with external CRO partners

Impact of the Role

This role significantly influences the success of the Novartis development pipeline by:

·        Enabling efficient and high‑quality execution of FiH and Clinical Pharmacology studies

·        Delivering key data supporting program milestones and regulatory submissions

·        Strengthening Clinical Pharmacology as a Novartis Center of Excellence across all BR therapeutic areas

·        Elevating scientific and medical expertise within TM and across development teams

Minimum Requirements

·        Medical degree (MD) combined with a PhD/post‑doctoral training, board certification, or relevant Clinical Pharmacology research experience

·        Significant experience in FiH and Clinical Pharmacology studies—either in biotech/pharma, as a PI/sub‑investigator at a CRO, or at an academic medical center

·        Proven track record of contributions to drug development, regulatory submissions, or high‑quality scientific publications

·        Experience within a TM therapeutic area is an asset

·        Full professional proficiency in English (spoken and written)

Commitment To Diversity and Inclusion
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to diversityandincl.india@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

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Skills Desired

Clinical Trials, Data Analysis, Data Monitoring, Drug Development, Drug Discovery, Medical Strategy, People Management