Research and Development
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(this posting is now closed/inactive)
Durham, NC 27701 United States
Research and Development
The Director of Drug Metabolism and Pharmacokinetics (DMPK) will champion the DMPK assessment and development of potential compounds across multiple indications and phases of clinical development. The role will be primarily scientific, focused on project support; with the possibility for 1-2 operational reports. The Director will have proven, high-level expertise in the DMPK-related aspects of drug development with a demonstrable track record leveraging skills to meet regulatory milestones.
•As a lead DMPK scientist provide strategic guidance, scientific expertise and development support to multiple project teams.
•Provide innovation in DMPK study designs and contribute to project plans to accelerate regulatory milestones.
•Author study protocols and reports (including PK and TK analyses).
•Effectively communicate DMPK data to project teams, senior management, and collaborators as necessary.
•Author and review regulatory submissions (INDs, CTAs, IBs, NDAs, etc.).
•Identify and liaise with CROs to request bids/proposals to conduct nonclinical DMPK studies.
•Liaise with Clinical Pharmacology colleagues to contextualize in vitro drug-drug interaction (DDI) data for the design of clinical DDI programs.
•Participate in performing reviews of due diligence data packages to identify issues/risks/gaps to development.
•Manage operational DMPK staff for generation of work orders/POs/invoices for contracted studies. Oversee timelines for studies, review and interpret data, revise as necessary CRO study protocols/reports to generate quality documents and study data to support regulatory submissions.
•Present data in the form of poster and/or oral presentations at relevant scientific meetings; draft manuscripts for peer-reviewed literature based on study results.
We are looking for a top-quality individual with the following characteristics:
•Deeply motivated self-starter with an entrepreneurial spirit
•Personality to thrive in a quickly changing, fast-paced environment
•A desire to work in multiple therapeutic areas
•An unrelenting dedication to delivering quality results
•An integrity role model by visibly and consistently speaking and acting with superior moral values
•Willingness to roll up your sleeves to get the job done
•Ability to work with CRO personnel and gain their trust and respect
•Willingness to travel up to 25%
Requirements for consideration include:
•PhD preferred, or BS/MS with equivalent experience
•Minimum of 15 years pharmaceutical industry (or related industry) experience. Knowledge of drug development and life cycle management concepts and interdependencies within the overall development process.
•In depth knowledge of DMPK studies required to meet regulatory requirements is essential, as is the ability to perform and interpret non-compartmental pharmacokinetic analyses.
•Broad knowledge of DMPK and its related disciplines (e.g. Pharmacology, Toxicology) and nonclinical drug development (e.g. Manufacturing, Clinical, Regulatory).
•Experience managing operational aspects of in vitro and in vivo DMPK studies.
•Experience performing reviews of due diligence data packages or regulatory documents to identify gaps and design project strategies to support clinical development activities.
•Ability to design study protocols and analyze and interpret study data with minimal supervision.
•Experience working in a fast-paced company or in a multi-project support role is desirable. Proven ability to manage multiple projects/tasks at one time is essential.
•Excellent written and oral communication skills. First author publication record required.
North Carolina Biotechnology Center