Drug Metabolism and Pharmacokinetics (DMPK) Consultant

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Drug Metabolism and Pharmacokinetics (DMPK) Consultant

Location:

Bethesda

Description:

Title : Drug Metabolism and Pharmacokinetics (DMPK) Consultant Location : Remote Position Summary : The DMPK Consultant shall provide consulting on an ad-hoc basis or while serving as an integral part of the BPN's Lead Development Teams (LDTs) composed of the principal investigator (PI), industry consultants, and NIH staff. The DMPK Consultant will guide the LDTs in mapping a product development and clinical evaluation research strategy, including milestones, and oversee manufacturing and nonclinical study services by Contract Manufacturing Organizations (CMOs) and Contract Research Organizations (CROs). Project assignment and specific consulting responsibilities will depend on the expertise of the DMPK Consultant and the needs of individual projects. A DMPK Consultant may be assigned to multiple projects in the exploratory through preclinical safety stages. Some projects may proceed to the investigational new drug (IND) and clinical trial stages. Duties/Responsibilities: Offer input on project milestones, target product profiles, and testing funnels. Evaluate pharmacokinetics study protocols and data to identify potential drug discovery and development challenges. Recommend strategies to address these challenges. In partnership with other consultants and contractors, develop plans to assist NIH staff in strategically managing pharmacokinetic programs that facilitate assay development, exploratory chemistry, lead optimization, formulation activities, investigational new drug (IND) enabling, and clinical studies. Assist BPN staff in designing investigative pharmacokinetics studies, including study strategy and experimental design within established budget limits. Provide recommendations regarding recommended study milestones and prepare milestone reports are needed. Evaluate DMPK activities for BPN compounds under development in accordance with US regulatory and International Council of Harmonization for Registration of Pharmaceuticals for Human Use (ICH) guidelines. Identify and assess regulatory risks for compounds under development and provide DMPK guidance to BPN and LDTs. Develop DMPK strategies which accord with US and international guidelines. Assist NIH staff and LDTs in ensuring timely preparation, review, and submission of DMPK documents to regulatory authorities including FDA, European Medicines Agency [EMA] and other authorities, to support the conduct of clinical trials and marketing applications. Analyze and interpret pharmacokinetics data for drug discovery, development, and translational projects. Facilitate LDT discussions via telephone and email regarding assigned drug metabolism and pharmacokinetics efforts. Visit CROs under contract to NIH to inspect facilities and discuss appropriateness of CRO-proposed methodology. Submit trip reports to NINDS program staff. Required Skills At least 15 years of experience managing or serving in a senior leadership role in drug discovery projects in the biopharmaceutical industry. Experience in drug discovery for nervous system conditions is preferred. Experience in biologics and/or small molecule drug development is preferred. At least 15 years of experience working at a senior level in multi-disciplinary teams in the biopharmaceutical industry, including teams with members from outside organizations and with members at various management levels. Extensive experience working in a cross-functional team environment and managing competing priorities. A doctorate degree in a pharmacology-related, scientific discipline. Extensive experience leading DMPK chemistry efforts performed by CROs. Extensive experience leading to expertise in managing drug portfolios. Skills/Abilities: Excellent interpersonal skills. Excellent written and oral communication skills. Excellent organization, writing, presentation, and documentation skills. Skilled in the use of computer applications for word processing, spreadsheets, presentations, e-mail, calendars, and database storage/retrieval. Able to work well in a cross-functional team environment and effectively manage competing priorities. Apply online at our website: https://kikiktagruk.applicantpool.com/ Disclaimer: This is not to be an exclusive list of all responsibilities', duties, and skills required of the person in this job. KIC is an Equal Opportunity Employer. KIC considers all applicants for employment without regard to race, color, sex, national origin, religion, age, physical or mental disability, family responsibility, marital status, sexual orientation, political affiliation, veteran's status or any other legal protected status. Pursuant to The Alaska Native Claims Settlement Act 43 U.S.C. Sec. 1601 et seq., and federal contractual requirements, Kikiktagruk Inupiat Corporation, may legally grant certain preference in employment opportunities to KIC Shareholders and their Descendants. EOE/AA/M/F/D/V. Please view Equal Employment Opportunity Posters provided by OFCCP here . Successful candidate must pass, comply and adhere to KIC's Drug and Alcohol policy/testing requirements and pass a thorough background check including fingerprinting.

Company:

Kikiktagruk Inupiat

Posted:

December 26 2023 on ApplicantPro

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Drug Metabolism and Pharmacokinetics (DMPK) Consultant | Consultant in Consulting Job Job at Kikik1

Drug Metabolism and Pharmacokinetics (DMPK) Consultant

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