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Associate Director, Translational Medicine Expert, TM Clinical Pharmacology

Novartis -
Hyderabad, Telangana

Apply Now

Job details

Full-time

Qualifications

Medicine
Doctoral degree
English
Pharmacy

Full 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

About the Role

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 [email protected] 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

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

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

Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
Read our handbook (PDF 30 MB)

Division

Biomedical Research

Business Unit

Research

Location

India

Site

Hyderabad (Office)

Company / Legal Entity

IN10 (FCRS = IN010) Novartis Healthcare Private Limited

Functional Area

Research & Development

Job Type

Full time

Employment Type

Regular

Shift Work

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 [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Apply Now

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