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VENUS MEDICINE RESEARCH CENTRE (VMRC)
Position: Head – Animal Pharmacology & Toxicology
Department: Preclinical Sciences
Reports To: Chief Scientific Officer
Location: On-site, Full-time
Role Overview
VMRC is advancing a diversified pipeline spanning novel anti-infectives, BL+BLI combinations, and differentiated herbal therapeutics. The Head – Animal Pharmacology & Toxicology will lead all in vivo pharmacology, ADME, toxicology, translational PK–PD, and pharmacometrics activities across the portfolio.
This is a senior scientific leadership role requiring deep expertise in anti-infective development, renal pharmacology, nephrotoxicity assessment, PK–PD modelling, and IND-enabling toxicology, combined with strong regulatory and team leadership capability.
Key Programmes
Renal Guard Programme (Phase 1)
A reformulated polymyxin programme focused on reducing nephrotoxicity while maintaining antimicrobial efficacy.
Key areas:
- Renal injury biomarkers: KIM-1, NGAL, Cystatin C, NAG, Osteopontin - Renal pharmacology and drug disposition - Histopathology integration - Complex PK interpretation in limited-literature settings
Meropenem + MET-X Programme (Late Preclinical)
A BL+BLI combination targeting carbapenem-resistant Gram-negative infections.
Key areas:
- IND-enabling ADME and toxicology - Translational PK–PD - Monte Carlo simulation & PTA - Dose optimisation using: - fT>MIC - fAUC/MIC - Cmax/MIC - Clinical dose projection and resistance suppression strategy
Qualifications & Experience
- Ph.D. in Pharmacology, Toxicology, Pharmaceutical Sciences,



Translational Medicine, or related discipline - 10+ years in preclinical in vivo drug development - 5+ years leading multidisciplinary preclinical teams - Experience advancing assets through IND/CTA-enabling development - Robust expertise in: - Anti-infectives - Toxicology - Renal pharmacology - PK–PD/pharmacometrics - GLP laboratory and regulatory submission experience preferred - Strong publication and scientific presentation record
Key Responsibilities
Scientific Leadership
- Define and execute portfolio-wide in vivo strategy - Lead pharmacology, toxicology, ADME, and PK–PD functions - Serve as Study Director/PI for internal and outsourced studies - Lead team development, budgeting, infrastructure, and resource planning - Interface with CMC, microbiology, clinical, regulatory, and bioanalytical teams
In Vivo Pharmacology & Infection Models
- Lead rodent and non-rodent infection models: - Thigh - Lung - Sepsis - Resistance amplification - Dose-fractionation studies - Evaluate exposure–response, bacterial burden, survival, and resistance suppression - Support herbal and metabolic programme evaluation
Renal Pharmacology & Toxicology




- Lead nephrotoxicity strategy for Renal Guard - Integrate biomarkers, PK, and histopathology - Interpret renal injury pathways and kidney drug disposition
ADME & Translational PK–PD
- Oversee PK, tissue distribution, ELF/renal penetration, and permeability studies - Lead NCA, compartmental and population PK analyses - Conduct PTA and Monte Carlo simulations - Support dose projection and breakpoint justification
Required tools:
- Phoenix Win Nonlin - NONMEM - R or equivalent platforms
Toxicology & Safety
- Oversee acute/repeat-dose toxicity, safety pharmacology, TK, and local tolerance studies - Interpret NOAEL, MTD, therapeutic index, and safety margins - Ensure alignment with ICH and IND/CTA requirements
Regulatory & GLP
- Lead nonclinical regulatory submissions: - CTD Modules 2.4, 2.6, 4 - FDA, EMA, CDSCO submissions - Drive GLP compliance, SOP quality, QA readiness, and facility accreditation - Support publications, scientific presentations, and regulatory interactions
Regulatory Knowledge (Non-Negotiable)
Strong working knowledge of:
- OECD GLP Principles - ICH M3(R2), S-series, E6(R2) - IAEC/CPCSEA guidelines - IBSC requirements - ARRIVE & 3Rs principles - IND/CTA/NDA nonclinical documentation
Ideal Candidate
- Proven anti-infective or antimicrobial development experience - Exposure to BL+BLI or combination products - Expertise in nephrotoxicity and renal biomarker science - Strong translational and regulatory mindset - Demonstrated ability to build high-performing preclinical teams and infrastructure

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📌 Head PreClinical- Animal Pharmacology & Toxicology (India)
🏢 Venus Remedies
📍 India