Consultant, Computational Pharmacology and Translational DMPK

Consultant, Computational Pharmacology and Translational DMPK About the Engagement VivaMed is seeking a consultant with expertise in computational pharmacology, translational DMPK, PK/PD, ADME, safety assessment, and exposure-based decision-making to help evaluate AI-assisted therapeutic hypotheses before external validation or CRO engagement. Many therapeutic concepts can appear biologically plausible but fail because of unrealistic exposure, poor dose feasibility, DDI risk, overlapping toxicity, inadequate PK/PD logic, route limitations, formulation constraints, or weak translational pharmacology. This role is designed to identify those issues early and help determine which concepts are credible enough to advance. This role is not intended to replace specialized formulation, CMC, toxicology, or wet-lab development teams. The goal is early pharmacologic and feasibility triage: determining whether a concept is realistic enough to advance toward internal decision-making, external expert review, CRO planning, or clinical feasibility assessment. Core Mission The consultant will help VivaMed determine whether therapeutic hypotheses are pharmacologically and developmentally realistic. This includes assessing whether proposed mechanisms can plausibly be engaged at clinically achievable exposure, whether combination therapies are feasible from a DDI and safety perspective, and whether selected formulation, route, or delivery concepts have a credible PK, biopharmaceutical, or development rationale. Key Responsibilities Assess PK, exposure, and dose realism for AI-assisted therapeutic hypotheses. Evaluate whether known or projected human exposure is sufficient to support the proposed Review drug repurposing concepts for exposure feasibility, tissue penetration, dose constraints, safety context, label limitations, and clinical feasibility in the proposed population. Assess combination therapy concepts for DDI risk, CYP and transporter liabilities, overlapping toxicities, dose and schedule feasibility, therapeutic-index concerns, and additive safety burden. Identify pharmacology, ADME, DMPK, tox, safety, or exposure risks that should delay or prevent advancement. Support evaluation of formulation, route, or delivery concepts at an early triage level, including oral bioavailability, solubility, permeability, depot feasibility, IV-to-SC plausibility, route-specific exposure assumptions, and patient or clinical-use rationale. Provide early risk-flagging for prodrug, cocrystal, salt, deuteration, or formulation concepts when relevant, while remaining clear about what desk-based or computational assessment can and cannot determine. Apply cheminformatics and molecular-level reasoning where useful for triage, including SMILES/InChI handling, molecular identity checks, physicochemical properties, structural alerts, similarity analysis, and ADME/Tox liability assessment. Review drug labels, clinical pharmacology data, dose and exposure information, safety findings, toxicology signals, and relevant literature. Define pharmacology-driven go/no-go criteria for selected hypotheses. Contribute to structured hypothesis review and validation-readiness packages, especially sections related to exposure assumptions, dose feasibility, DDI, safety, pharmacology, route feasibility, and development risk. Work with translational, biology, computational, and CRO-facing teams to improve triage quality before external spend. Relevant Program Areas The consultant may support: Drug repurposing and indication expansion Combination therapy CNS, pain, addiction, cardiometabolic, rare disease, and selective IO/immunology programs Exposure and safety review for biomarker-defined rescue concepts Formulation, route, or delivery concepts requiring early PK or biopharmaceutical feasibility assessment assessment Selected biologic or biobetter hypotheses requiring PK, safety, or developability risk review 505(b)(2)-oriented development concepts where prior human exposure, label context, and clinical feasibility are important PK and exposure realism assessments Dose feasibility memos DDI and CYP/transporter risk tables Safety and toxicity-overlap matrices Therapeutic-index and exposure-margin assessments Prior clinical exposure and label reviews ADME/Tox and molecular liability summaries Route or formulation feasibility risk summaries Combination pharmacology risk summaries Pharmacology-driven advance, hold, or shelve recommendations Validation-planning assumptions for dose, concentration range, schedule, exposure margins, and go/no-go thresholds. Required Qualifications PhD, MD/PhD, PharmD with substantial drug discovery, DMPK, clinical pharmacology, translational pharmacology, or early development experience, or MS with significant pharma-facing experience, preferably 15+ years, in DMPK, clinical pharmacology, pharmacometrics, computational pharmacology, toxicology, ADME, translational pharmacology, pharmaceutical sciences, or a related discipline. Experience in pharma, biotech, CRO, or translational drug development settings. Strong understanding of PK/PD, ADME, dose/exposure relationships, DDI, safety margins, tissue exposure, therapeutic index, and translational pharmacology. Ability to interpret clinical pharmacology data, drug labels, safety findings, toxicology signals, and literature to support early program decisions. Familiarity with small-molecule development and ability to support selected biologic, formulation, working knowledge of molecular properties, compound identity, SMILES/InChI, ADME/Tox prediction concepts, and structure-based liability assessment. Ability to communicate pharmacology and safety risks clearly to non-specialist stakeholders. Strong judgment around what can and cannot be concluded from desk-based or computational review. Preferred Qualifications Experience with drug repurposing, combination therapy, dose optimization, safety pharmacology, toxicology interpretation, model-informed drug development, or 505(b)(2)-oriented development. Familiarity with CYP/transporter interactions, exposure-response analysis, PBPK concepts, pharmacometrics, quantitative systems pharmacology, or translational PK/PD. Experience supporting preclinical-to-clinical translation or early development decisions. Experience reviewing formulation, route, delivery, or biopharmaceutic feasibility at an early concept stage. Familiarity with cheminformatics tools, molecular descriptors, structural alerts, similarity analysis, hERG/QT risk concepts, reactive metabolite concerns, hepatotoxicity signals, or other ADME/Tox screening approaches. Experience working with CROs or helping define experimental assumptions for external validation. What This Role Is Not This is not a narrow cheminformatics-only role, not a formulation-development-only role, and not a software engineering role. The consultant must be able to judge whether a therapeutic hypothesis is pharmacologically and developmentally realistic. Candidates who can generate molecular descriptors or build models but cannot interpret dose, exposure, DDI, toxicity, route feasibility, or development relevance are unlikely to be the right fit. Engagement Structure This is initially envisioned as a consultant or fractional expert engagement. Scope may be structured around hypothesis-review batches, specific therapeutic areas, combination-therapy reviews, exposure-risk assessments, ADME/Tox screens, or formulation and route feasibility reviews. Computational Pharmacology and Translational DMPK: $80–$120/hour #J-18808-Ljbffr VivaMed BioPharma