Title: Drug Metabolism and Pharmacokinetics (DMPK) Consultant
Location: Remote
Status: Part-Time
Travel: Limited Travel (anticipated 8 hours annually)
Salary Range: $100 - $150 per hour
Position Summary:
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.
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.

MINIMUM REQUIREMENTS:

• An advanced degree in a life or physical science discipline is required.
• 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.
• Experience in small molecule and biologics therapeutics will be considered a plus.
• 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. Experience with drug discovery for nervous system conditions is preferred.
• 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.
• Consultants must have strong interpersonal skills, an attention to detail, excellent organizational, writing, communication, presentation, and documentation skills as well as computer and software literacy.
  Apply online at our website: https://kikiktagruk.applicantpool.com/

• Provide collaborative support while serving on NIH BPN Lead Development Teams.
• Attend weekly/biweekly meetings via teleconference for approximately two hours. Projects may require between three-ten hours weekly, inclusive of meeting and preparation time. Some projects many proceed to investigational new drug (IND) and clinical trial stages.
• 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 which facilitate assay development, exploratory chemistry, lead optimization, formulation activities, investigational new drug (IND) enabling, and clinical studies.
• 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.
• 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 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
• Analyze and interpret data for pharmacokinetics drug discovery, development, and translational projects.
• Facilitate Lead Development Team discussions via telephone and email regarding assigned drug metabolism and pharmacokinetics efforts.
• 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.
• Work in a cross-functional team environment and manage competing priorities.
• Participate actively in LDT discussions.
• Educate and build trust with LDT members of many disciplines to build consensus and maintaining focus of team on milestone achievement.
• All other duties as assigned.