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Work Experience in Relevant Field

10-20 Years

Technical Skills Required

VMRC is advancing a multi-programme preclinical and clinical pipeline spanning novel anti-infective formulations, beta-lactam/beta-lactamase inhibitor (BL+BLI) combinations, and differentiated herbal therapeutics. The Head â€“ Animal Pharmacology & Toxicology will serve as the senior scientific leader responsible for all in vivo pharmacology, ADME, toxicology, PKâ€“PD integration, and pharmacometrics across the portfolio. This is a scientifically demanding role that requires first-principles reasoning across diverse therapeutic areas â€” from renal pharmacology and nephrotoxicity biomarker science to anti-infective PKâ€“PD modelling and herbal product evaluation. The successful candidate will combine deep domain expertise with the ability to elevate documentation quality, regulatory readiness, and external scientific representation of VMRC.

Pipeline Context The candidate will provide scientific leadership across the following active programmes: Renal Guard Programme (Phase 1) A reformulated polymyxin aimed at reducing nephrotoxicity while preserving antimicrobial efficacy. This programme involves extensive use of novel renal injury biomarkers (KIM-1, Cystatin C, NAG, NGAL, Osteopontin), requires deep understanding of kidney pharmacology, drug disposition in renal compartments, and the ability to reason about complex PK relationships in an area with sparse published literature. Histopathological assessment is a core component. Meropenem + MET-X Programme (Late Preclinical) A BL+BLI combination product targeting carbapenem-resistant Gram-negative infections in critical care, with MET-X being a novel chemical entity. This programme demands comprehensive understanding of IND-enabling requirements across ADME and toxicology, advanced PKâ€“PD concepts including probability of target attainment (PTA), Monte Carlo simulation, and PKâ€“PD index-driven dose optimisation (fT>MIC, fAUC/MIC). Concept clarity on translational pharmacology is critical.

Additional Programmes Novel herbal formulations being evaluated against established pharmacological benchmarks â€” including GLP-1 receptor agonists for obesity (high-fat diet and obesity models) and herbal antacid formulations benchmarked against allopathic alternatives. These require rigorous study design and pharmacological reasoning, even within a non-allopathic framework.

JOB DESCRIPTION

Who You'll Work With

Key Responsibilities 1. Scientific & Departmental Leadership 1. Define and execute the overall preclinical in vivo strategy aligned with portfolio priorities across all active programmes. 2. Lead annual planning, resource allocation, budgeting, and infrastructure development for the animal pharmacology and toxicology function. 3. Serve as Study Director or Principal Investigator for internal and outsourced non-clinical studies â€” responsible for study design approval, protocol sign-off, conduct oversight, data interpretation, and final report sign-off. 4. Act as the primary scientific interface between the in vivo function and CMC, in vitro microbiology, bioanalytical, clinical, regulatory, and strategy teams. 5. Drive translational decision-making under aggressive development timelines, applying first-principles reasoning to complex scientific questions. 6. Lead, mentor, and develop preclinical scientists, pathologists, and technicians â€” actively building and scaling the team against current openings. 2. In Vivo Pharmacology & Infection Model Leadership 1. Design, supervise, and interpret rodent and non-rodent infection models relevant to the anti-infective pipeline, including thigh infection, lung infection, sepsis, resistance amplification, and dose-fractionation models. 2. Ensure translational relevance of preclinical infection models to human clinical settings, particularly for critical care indications. 3. Evaluate bacterial burden reduction, survival endpoints, exposureâ€“response relationships, and resistance suppression across programmes. 4. Lead pharmacological evaluation of non-anti-infective programmes, including high-fat diet/obesity models and comparative efficacy studies for herbal formulations. 3. Renal Pharmacology & Nephrotoxicity Assessment 1. Provide scientific leadership for the Renal Guard programmeâ€™s nephrotoxicity evaluation strategy, including study design, biomarker selection, and interpretation. 2. Demonstrate deep understanding of renal physiology, tubular injury pathways, and drug disposition in renal compartments. 3. Oversee the application and interpretation of novel renal injury biomarkers: KIM-1, Cystatin C, NAG, NGAL, Osteopontin, and emerging markers. 4. Integrate histopathological findings (working closely with the in-house pathologist) with biomarker and pharmacokinetic data to build a coherent nephrotoxicity narrative. 5. Navigate areas with limited published literature using first-principles pharmacological reasoning. 4. ADME & Drug Disposition 1. Lead design and interpretation of in vivo ADME studies: pharmacokinetics, tissue distribution, target-site penetration (e.g. ELF, renal cortex), and permeability assessments. 2. Identify ADME liabilities early in development and recommend mitigation strategies. 3. Integrate ADME data into PKâ€“PD frameworks and translational models for dose projection. 5. Translational PKâ€“PD & Pharmacometrics 1. Lead PKâ€“PD modelling and simulation, including non-compartmental analysis (NCA), compartmental modelling, and population PK approaches. 2. Determine and justify PKâ€“PD indices (fT>MIC, fAUC/MIC, Cmax/MIC) for anti-infective programmes. 3. Conduct and oversee Monte Carlo simulations and Probability of Target Attainment (PTA) analyses to support clinical dose projection and breakpoint justification. 4. Integrate PKâ€“PD findings into clinical dose projection, breakpoint justification, and resistance suppression strategy. 5. Proficiency with relevant platforms: Phoenix WinNonlin, NONMEM, R, or equivalent pharmacometric tools. 6. Toxicology & Safety Assessment 1. Provide scientific oversight for acute and repeat-dose toxicity studies, safety pharmacology (cardiovascular, respiratory, CNS), local tolerance, and toxicokinetic (TK) integration. 2. Interpret NOAEL, MTD, therapeutic index, and safety margins in the context of intended clinical use. 3. Ensure toxicology programmes are aligned with ICH M3(R2), ICH S6(R1), and other relevant guidelines for IND/CTA/NDA submissions. 4. Coordinate with the pathology team on histopathological evaluation, peer review, and pathology narrative integration into study reports. 7. Regulatory, Documentation & Scientific Communication 1. Lead preparation and critical review of nonclinical sections for IND/CTA/NDA submissions to global regulatory authorities (FDA, EMA, CDSCO, and others). 2. Develop integrated nonclinical summaries and overviews (Module 2.4, 2.6) encompassing pharmacology, ADME, PKâ€“PD, and toxicology data. 3. Elevate documentation practices across the department â€” improving SOP quality, study report rigour, data presentation standards, and regulatory submission readiness. 4. Author and guide scientific manuscripts for peer-reviewed publication; support the teamâ€™s publication output. 5. Represent VMRC at international scientific conferences, regulatory meetings, and expert advisory interactions. 6. Participate in and respond to regulatory agency queries during the review process. 8. GLP Compliance & Laboratory Standards 1. Lead re-establishment of GLP accreditation for the VMRC animal facility following infrastructure transition, with end-to-end familiarity with GLP norms and inspection requirements. 2. Develop and maintain GLP-aligned SOPs, documentation systems, training programmes, and archival practices. 3. Oversee QA interface, inspection readiness, and corrective/preventive action processes. 4. Ensure equipment qualification (IQ/OQ/PQ) and facility validation are maintained. 5. Promote a strong culture of data integrity, compliance, and scientific rigour. Regulatory & Compliance Knowledge (Non-Negotiable) The candidate must demonstrate comprehensive, working knowledge of the following frameworks as applicable to VMRCâ€™s preclinical operations: â€¢ GLP (OECD Principles of Good Laboratory Practice) â€” end-to-end familiarity â€¢ ICH Guidelines: M3(R2), S1â€“S11 series (as relevant to programme stage), E6(R2) for clinical interface â€¢ IBSC (Institutional Biosafety Committee) requirements for work involving recombinant organisms or biohazardous materials â€¢ IAEC / CPCSEA guidelines for ethical conduct of animal experimentation (India-specific) and alignment with international standards (ARRIVE, 3Rs) â€¢ IEC (Institutional Ethics Committee) â€” understanding of interface between preclinical data packages and clinical ethics submissions â€¢ Regulatory submission formats: CTD Module 2.4, 2.6, Module 4 (nonclinical study reports)

What You'll Do

Key Competencies â€¢ First-principles scientific reasoning â€” ability to navigate complex pharmacological questions in areas with limited precedent â€¢ Deep expertise spanning animal pharmacology, toxicology, renal pharmacology, and PKâ€“PD science â€¢ Strong background in in vivo infection models and translational anti-infective development â€¢ Proven ability to lead and develop multidisciplinary preclinical teams (pharmacologists, toxicologists, pathologists, technicians) â€¢ Exceptional scientific writing and presentation skills â€” publications, regulatory documents, conference presentations â€¢ Regulatory-facing experience with IND/CTA/NDA submissions across multiple global agencies â€¢ Rigorous approach to documentation, data integrity, and study reporting â€¢ Ability to operate across diverse therapeutic areas (anti-infectives, metabolic, herbal) with intellectual flexibility Ideal Candidate Profile â€¢ Demonstrated success in advancing antimicrobial or anti-infective assets through IND-enabling development into clinical studies. â€¢ Experience with combination product development (BL+BLI or similar) and the associated regulatory complexity. â€¢ Exposure to nephrotoxicity assessment, renal biomarker science, or kidney pharmacology. â€¢ Track record of peer-reviewed publications and conference presentations in relevant domains. â€¢ Experience building or significantly strengthening preclinical teams and infrastructure. â€¢ Strong decision-making under compressed timelines with ability to translate complex data into actionable development strategy. â€¢ Comfort operating in a research centre environment where scientific curiosity and rigour coexist with pragmatic drug development timelines.

Functional Area

R&D

Recruitment Status

Urgent

Employment Type

Full Time

Date of Joining

02.05.2026

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Head Animal Pharmacology Toxicology

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Head Animal Pharmacology & Toxicology

Job Posting: 02/26/2026

Baddi

JOB REQUIREMENTS

Mandatory Qualifications

Doctorate

Work Experience in Relevant Field

10-20 Years

Technical Skills Required

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