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Director, Clinical and Translational PK/PD

Company: Larimar Therapeutics
Location: Woodbury Heights
Posted on: May 28, 2023

Job Description:

Description:Larimar Therapeutics Inc (Bala Cynwyd, PA) is a clinical-stage biotechnology company focused on developing treatments for complex rare diseases. Larimar's lead compound, CTI-1601, is being developed as a potential treatment for Friedreich's Ataxia. Larimar also plans to use its intracellular delivery platform to design other fusion proteins to target additional rare diseases characterized by deficiencies in intracellular bioactive compounds. The Director will provide strategic insight and technical leadership for clinical and nonclinical pharmacology, specifically in PK and PD to support Larimar's portfolio. The incumbent shall serve as the PK/PD expert leading the characterizations of ADME, dose-exposure and exposure-response analyses, translational modeling, population PK, PBPK and PK/PD modeling, across preclinical and clinical development phases. In this role, the incumbent will be expected to contribute to R&D from bench-to-bedside, i.e., from in vitro experimental stages to clinical pharmacology to advance innovations, new therapies, as well as novel diagnostics into practice in a clinical setting.The candidate should have proven industry experience supporting nonclinical and clinical drug development programs, including strong collaborations with external contract research organizations (CROs). The candidate should be a highly organized, engaged contributor, with strong leadership skills. This job offers hybrid flexibility with encouragement to work on-site at least 2 days per week; a fully remote work request will be considered for a limited period or with agreement on periodic visits to the Larimar headquarters.This is an exciting opportunity to be part of a passionate, high-impact R&D team in a highly dynamic and collaborative setting of an entrepreneurial, fast-paced, biotechnology company. Job Duties/Responsibilities:1. Design robust studies and perform analyses to drive clinical pharmacology strategies and decisions2. Design and interpret nonclinical TK and PK/PD studies to provide preclinical discovery and development guidance via translational inputs and mechanistic modeling; advise on animal model PK/PD, receptor occupancy and translate insights to predict doses for clinical investigation3. Develop first-in-human dose justification; provide decisive rationale for dose regimen selection, safety margin assessment and identification of circumstances where dose adjustment or patient selection/stratification should be considered4. Perform non-compartmental PK, population PK, exposure-response, PK/PD analysis, modeling and simulation, meta-analyses, disease and systems biology modelling, etc to integrate nonclinical data and clinical data to guide dose/regimen optimization and recommended phase 2 dose and schedule selection5. Develop models that support hypotheses and produce predictions that improve preclinical and clinical study designs6. Contribute to strategy development for regulatory filings and follow-up responses, with direct responsibility for clinical pharmacology sections of regulatory documents (including the protocol, IB, briefing package, IND, BLA, etc.). Write, edit, and finalize relevant nonclinical and clinical sections of regulatory documents and play a key role in interactions with global health authorities. 7. Collaborate with consultants and/or CROs on clinical pharmacology activities to complement in-house expertise and/or capacity8. Contribute to the preparation of publications, including manuscripts, abstracts, posters and oral presentations9. Contribute to scientific due diligence and pipeline development activities, as assignedRequirements:1. PharmD or Ph.D. in Pharmacokinetics, DMPK or Pharmacometrics, and 10+ years' related industry experience 2. Translational and clinical development experience, with emphasis on pharmacokinetics, dose selection rationale/justification, clinical trial design and executing clinical pharmacology components of clinical studies3. Expertise in state-of-the-art quantitative modeling, including translational PK/PD, population PK, and exposure-response analyses, to integrate nonclinical data and clinical data to guide dose/schedule optimization and recommended phase 2 dose and schedule selection4. Track record of applying modeling and simulation methodologies to inform and accelerate drug development; experience working with animal models and ability to design experiments aimed at predicting clinical outcomes5. Prior experience with IND/BLA/NDA/MAA submissions6. Experience in collaborating with consultants and CROs preferred7. Excellent critical thinking and scientific skills, and a demonstrated ability to analyze, interpret, and clearly communicate complex results; excellent oral and written communication skills; experience in writing technical and management documents, reports and presentations8. Working knowledge of regulatory and compliance processes or standards9. Training and experience with PK and relevant statistical software (e.g. NONMEM, Monolix, Phoenix, WinNonlin, R, WinBUGS, SAS)PI216045045

Keywords: Larimar Therapeutics, Philadelphia , Director, Clinical and Translational PK/PD, Executive , Woodbury Heights, Pennsylvania

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