Associate Director, Translational Medicine Expert (TM Clinical Pharmacology) | Novartis
Company: Novartis Careers
Position: Associate Director, Translational Medicine Expert (TM Clinical Pharmacology)
Job ID: REQ-10077149
Location: Hyderabad
Division: Biomedical Research
Business Unit: Research
Functional Area: Research & Development
Employment Type: Regular | Full-Time
Posted On: May 6, 2026
Shift Work: No
Role Overview
The Associate Director, Translational Medicine Expert (TME), Clinical Pharmacology is a senior scientific and medical leadership role responsible for overseeing:
First-in-Human (FiH) studies
Clinical Pharmacology studies
Medical supervision
Participant safety
Scientific strategy
Cross-functional clinical collaboration
The role serves as the primary medical and scientific lead for Clinical Pharmacology programs and contributes directly to:
Early development programs
Translational medicine initiatives
Regulatory submissions
Strategic drug development decisions
About the Team
TM Clinical Pharmacology Group
The TM Clinical Pharmacology team is a cross-functional expert organization responsible for:
Designing Clinical Pharmacology studies
Executing FiH studies
Reporting clinical trial outcomes
Supporting all therapeutic areas across Biomedical Research
The organization works through a strategic outsourcing model in partnership with:
CROs (Contract Research Organizations)
Internal translational medicine teams
Development and regulatory stakeholders
Key Responsibilities
1. Clinical Pharmacology Portfolio Leadership
Lead multiple FiH and Clinical Pharmacology studies simultaneously.
Responsibilities include:
Medical and scientific oversight
Operational leadership
Ensuring participant safety
Delivering high-quality clinical data
2. Study Design & Scientific Contributions
Provide expert input into:
Study Concept Sheets
Clinical trial protocols
Informed Consent Forms (ICFs)
Statistical Analysis Plans (SAPs)
TLF shells (Tables, Listings, Figures)
3. Medical & Safety Oversight
Oversee:
Site Initiation Visits
Ongoing safety monitoring
Medical coding activities
Safety reporting processes
Ensure:
Regulatory compliance
Scientific rigor
High-quality medical governance
4. Clinical Reporting & Scientific Dissemination
Lead and contribute to:
Clinical Study Reports (CSRs)
Scientific abstracts
Posters
Manuscripts
Technical summaries
Plain-language summaries
5. Clinical Pharmacology Strategy
Provide strategic Clinical Pharmacology guidance to:
Optimize study design
Align with program objectives
Support translational medicine strategies
Inform development milestones
6. Cross-Functional Collaboration
Collaborate closely with:
Project-level TMEs
Clinical Pharmacology Trial Teams
CRO partners
Internal development stakeholders
Support:
Program strategy alignment
Compound background discussions
Cross-functional scientific initiatives
7. Organizational & Capability Development
Lead or contribute to:
Process optimization initiatives
Capability-building efforts
Clinical Pharmacology strategic improvements
Center of Excellence development activities
Impact of the Role
This role contributes significantly to Novartis’ drug development pipeline by:
Enabling high-quality FiH and CP study execution
Supporting regulatory submissions
Generating critical translational medicine insights
Advancing scientific excellence across therapeutic areas
Required Qualifications
Education
Candidates should have:
MD (Medical Degree)
AND one or more of the following:
PhD
Post-doctoral training
Board certification
Relevant Clinical Pharmacology research experience
Experience
Strong experience in:
First-in-Human (FiH) studies
Clinical Pharmacology studies
Drug development environments
Preferred backgrounds include:
Pharmaceutical companies
Biotechnology organizations
CROs
Academic medical centers
Scientific & Industry Expertise
Candidates should demonstrate:
Contributions to regulatory submissions
Scientific publications
Translational medicine expertise
Clinical development experience
Experience in a Translational Medicine therapeutic area is considered an advantage.
Soft Skills & Leadership
Strong capabilities in:
Scientific leadership
Cross-functional collaboration
Strategic thinking
Stakeholder communication
Medical decision-making
Global team collaboration
Language Requirement
Full professional proficiency in English
Written
Spoken
Why Join Novartis?
This role offers opportunities to:
Influence global drug development programs
Lead cutting-edge Clinical Pharmacology studies
Contribute to translational medicine innovation
Work across multiple therapeutic areas
Collaborate with world-class scientific teams
Shape regulatory and development strategies
Diversity & Inclusion
Novartis is committed to:
Building diverse and inclusive teams
Equal opportunity employment
Supporting accessibility and accommodations during recruitment and employment
Helpful Links
Careers
People & Culture
Talent Network
Benefits & Rewards
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