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 — 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 — 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, exposure–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 programme’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 PK–PD frameworks and translational models for dose projection. 5. Translational PK–PD & Pharmacometrics 1. Lead PK–PD modelling and simulation, including non-compartmental analysis (NCA), compartmental modelling, and population PK approaches. 2. Determine and justify PK–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 PK–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, PK–PD, and toxicology data. 3. Elevate documentation practices across the department — 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 team’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 VMRC’s preclinical operations: • GLP (OECD Principles of Good Laboratory Practice) — end-to-end familiarity • ICH Guidelines: M3(R2), S1–S11 series (as relevant to programme stage), E6(R2) for clinical interface • IBSC (Institutional Biosafety Committee) requirements for work involving recombinant organisms or biohazardous materials • IAEC / CPCSEA guidelines for ethical conduct of animal experimentation (India-specific) and alignment with international standards (ARRIVE, 3Rs) • IEC (Institutional Ethics Committee) — understanding of interface between preclinical data packages and clinical ethics submissions • Regulatory submission formats: CTD Module 2.4, 2.6, Module 4 (nonclinical study reports)
