Hobson Prior are seeking for a Head of DMPK/Clinical Pharmacology to join a rapidly growing biopharmaceutical company. This role will be on a permanent basis and will be remote based in the US.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• Function as subject matter expert supporting all nonclinical, DMPK and clinical pharmacology development for small molecule oral drugs in development in the Oncology therapeutic area.
• Determine and execute on strategy for DMPK and clinical pharmacology studies, including an assessment of required studies, gap analysis, vendor selection and oversight, and data interpretation. Develop strategy and work with vendors on clinical pharmacology studies including BA/BE, DDI, popPK, PBPK and E-R modeling.
• Lead authoring of nonclinical, PK and clinical pharmacology modules of NDA, MAA, etc.
• Work independently and with project teams to develop and execute clinical pharmacology development programs, PK/PD modeling and/or bioanalysis of PK samples.
• Analyze, summarize and interpret nonclinical and clinical pharmacology data and/or integrate study results into the ongoing clinical development strategy.
• Manage external vendors/CROs involved in the clinical studies.
• Aid in the design plans to support regulatory filings such as eCTD/NDA etc.
• Participate in authoring and review of PK and clinical pharmacology sections of regulatory documents (e.g., protocols, SAPs, CSRs, IBs) and responses to regulatory agencies.

Key Skills:

• Excellent oral and written communication skills.
• Strong leadership skills.

Requirements:

• PhD in pharmacokinetics, clinical pharmacology, pharmacometrics, drug metabolism, pharmacology or related discipline.
• 7+ years of research and development experience with at least 5 years within the pharmaceutical industry, at least some of which has been in start-up environment, with demonstrated experience in advancing clinical pharmacology studies through clinical development.
• Must be strategic as well as hands-on.
• Substantial experience with managing clinical pharmacology vendors/CROs.
• Hands-on experience with population PK, PBPK and E-R modeling.
• Hands-on experience in directing strategy and authoring nonclinical, PK and clinical pharmacology modules of NDA and MAA.
• Oncology small molecule experience preferred.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.