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Subject Matter Expert Consultant for Drug Metabolism Pharmacokinetics (DMPK)

Kikiktagruk Inupiat Corporation
Silver Spring, MD
  • Posted: over a month ago
  • Part-Time
Job Description

Title: Subject Matter Expert Consultant for Drug Metabolism Pharmacokinetics [DMPK].

Location: Silver Spring, MD with Telework Flexibility

Status: Part-Time

Travel: Travel Negligible


Position Summary:

The National Institutes of Health (NIH) is the nation's leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting and making medical discoveries that improve people's health and save lives.

The NIH Blueprint for Neuroscience Research, a consortium of 8 NIH Institutes and Centers that support neuroscience research, established the Blueprint Neurotherapeutics Network (BPN) as a pipeline between the typical endpoint of NIH-funded research and the beginning of industry drug development. The BPN provides neuroscience researchers with funding and access to a full range of industry-style drug development services and expertise. The program is intended for projects requiring medicinal chemistry optimization and contract research organization (CRO) support through Phase I clinical testing. Each project is directed by a Lead Development Team (LDT) composed of the principal investigator (PI), industry consultants hired by NIH, and NIH staff. This team maps out a research strategy, including milestones, and oversees implementation by CROs. Bioactivity and efficacy studies are funded through an award to the PI; other research services can be provided without cost to the PI through NIH contracts.


Duties/Responsibilities:

DMPK consultants will be expected to provide executive (senior scientific)-level DMPK expertise and contribute feedback and guidance on projects to the NIH and to LDT members through video/tele conference calls and by email. The role of the DMPK consultant may include but is not limited to the following responsibilities and tasks:


  1. Offer input on project milestones, target product profiles, and testing funnels
  2. Evaluate pharmacokinetics study protocols and data to identify potential drug discovery and development challenges. Recommend strategies to address these challenges.
  3. In partnership with other consultants and contractors, develop plans to assist NIH staff in strategically managing pharmacokinetic programs which facilitate assay development, exploratory chemistry, lead optimization, formulation activities, investigational new drug (IND) enabling, and clinical studies.
  4. Assist BPN staff to design investigative pharmacokinetics studies, including study strategy and experimental design bearing budget constraints in mind. Provide advice regarding recommended study milestones and prepare milestone reports are needed.
  5. 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.
  6. 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.
  7. Assist NIH staff and LDT in ensuring timely preparation, review, and submission of DMPK documents to regulatory authorities including FDA, European Medicines Agency [EMA] and other national authorities, to support the conduct of clinical trials and marketing applications
  8. Analyze and interpret data for pharmacokinetics drug discovery, development, and translational projects.
  9. Facilitate Lead Development Team discussions via telephone and email regarding assigned drug metabolism and pharmacokinetics efforts.
  10. Accompany NIH staff or visit, at BPN program staff request, Contract Research Organizations [CRO] under contract to the BPN program. Inspect facilities and discuss appropriateness of CRO proposed methodology. Submit trip reports to BPN program staff.
  11. Must participate actively in LDT discussions.



Education and work experience requirements

  • An advanced degree in a life or physical science discipline is required.
  • Minimum 15 years of experience in pharmacokinetics and drug metabolism of small molecules.
  • Experience in executing and managing drug development tasks, preferably with experience in developing drugs for nervous system conditions.
  • A track record of advancing projects into drug development. Measures of success include patents, Investigational New Drug (IND) applications, publications, and drugs brought to market.
  • Previous experiences in identifying and anticipating problems early in a project, overcoming technical difficulties, and making strategic decisions that make wise use of limited resources (including terminating projects that appear unlikely to succeed) will be considered as signs of a strong track record in drug development.
  • Expertise leading DMPK chemistry efforts performed by contract research organizations and managing drug project portfolios.

General requirements


  • Extensive experience in managing drug discovery and early development (e.g. Phase I clinical) DMPK efforts as evidenced by employment as an executive (senior scientific)-leader in drug discovery projects in the biopharmaceutical industry or as an experienced consultant providing the same services.
  • Strong interpersonal skills, ability to work in a team environment, attention to detail, excellent organizational, writing, communication, presentation, and documentation skills as well as computer and software literacy.
  • Ability to educate and build trust with LDT members of many disciplines to build consensus and maintaining focus of team on milestone achievement.
  • Consultants must have experience working with multi-disciplinary teams at a senior level in the biopharmaceutical industry, especially teams with members from outside organizations and members at various management levels.



Preferred Skills

  • Experience in small molecule and biologics therapeutics.
  • Experience with drug discovery for nervous system conditions.

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.

Kikiktagruk Inupiat Corporation

Address

Silver Spring, MD
20901 USA

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Science

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