Summary

We are seeking a highly motivated Clinical Pharmacologist to join our global clinical development team based in Bangalore. In this role, you will lead the clinical pharmacology strategy and clinical trial protocol design across our diverse therapeutic pipeline, which spans ophthalmology, hepatology, and autoimmune diseases. You will translate preclinical findings into robust human clinical protocols, optimize dosing strategies for unique patient populations, and collaborate with cross-functional teams to advance our pipeline from Phase I through Phase IV

Key Responsibilities

• Protocol Design & Strategy: Lead the clinical pharmacology design of Phase I–IV clinical trial protocols, ensuring rigorous scientific frameworks for first-in-human, drug-drug interaction, and special population studies
• Therapeutic Application: Apply targeted clinical pharmacology principles unique to our core therapeutic areas, including ocular drug delivery kinetics, liver impairment dosing adjustments, and small molecule dynamics in autoimmune conditions
• PK/PD Input: Collaborate with quantitative modelling teams to interpret pharmacokinetic (PK) and pharmacodynamic (PD) data to establish clear proof-of-concept and justify dose selection
• Regulatory Authoring: Draft and review clinical pharmacology sections of vital global regulatory submissions, including Investigator’s Brochures (IB), Investigational New Drug (IND) applications, and clinical study reports
• Cross-Functional Collaboration: Act as the core clinical pharmacology representative on multidisciplinary project teams, aligning strategies with clinical operations, biostatistics, toxicology, and regulatory affairs across global sites
• Biomarker Integration: Partner with translational medicine to incorporate safety, efficacy, and imaging biomarkers (such as ocular imaging or liver stiffness metrics) into clinical trial designs

Skills and Competencies

• Therapeutic Familiarity: Practical experience or strong foundational knowledge working within ophthalmology (e.g., intravitreal/topical kinetics), hepatology (e.g., MASH/NASH, hepatic impairment), or immunology/autoimmune diseases
• Regulatory Insight: Thorough understanding of global regulatory mandates (FDA, EMA, and ICH regulations), particularly guidelines concerning drug development, safety, and dosing in special populations
• Communication: Exceptional technical writing and English communication skills, with the ability to clearly articulate clinical pharmacology strategies to both scientific and operational stakeholders globally

Preferred Skills

• Experience managing clinical pharmacology studies for either small molecule or biologics (e.g., monoclonal antibodies)
• Familiarity with the operational challenges of complex clinical trials, including patient recruitment and specialized clinical site requirements