Director, Clinical Pharmacology

General Description of the Role:

The Director of Clinical Pharmacology will be responsible for developing and executing clinical pharmacology strategies for small molecule assets in the company portfolio. They will provide expertise in characterizing the pharmacokinetics properties, dose optimization strategies, pharmacometrics assessments, investigating drug interaction potential, food-effect, characterizing QT prolongation potential. They will represent the function in cross-functional meetings and collaborations with key stakeholders like Clinical, Research, DMPK, Biometrics, Translational Medicine, Regulatory, and CMC. Responsibilities will include planning and reviewing study designs & analysis plans; analysis & interpretation of PK, PK/PD data. They will also be responsible for authoring and defending the Clinical Pharmacology sections of regulatory filings.

Job Responsibilities

•                     Develop and execute clinical pharmacology and pharmacometrics strategies, including dose and schedule determination and dose optimization, to mitigate risks and support development of small molecule candidates from pre-IND and first-in-human testing through all phases of clinical development.

•                     Integrate clinical pharmacology knowledge with a broad understanding of and collaboration with related disciplines such as clinical development, biostats, regulatory, nonclinical and research to support and impact development decisions

•                     Responsible for protocol design of clinical pharmacology trials, study planning, review, data analysis / interpretation, and reporting of individual studies implemented to support clinical pharmacology components of project plans.

•                     Prepare appropriate documents or sections of clinical protocols, clinical study reports with respect to Clinical Pharmacology studies or data.

•                     Author regulatory documents (IND’s, NDA’s, IB’s, etc.) and respond to regulatory inquiries related to PK/PD, and clinical pharmacology.

•                     Identify and manage consultants and vendors and monitor work with external vendors to ensure compliance with agreed protocols, quality standards and timelines.

•                     Review external data, analysis, interpretation, and reporting of clinical pharmacokinetic and pharmacodynamic data.

•                     Ensure that appropriate PK, PD and PK/PD data analyses (including population PK, PK/PD modeling and simulation) are conducted for each study/program while adhering to timelines and budgets to insure prompt and accurate execution of deliverables from clinical pharmacology studies and programs.

•                     Analyze, interpret, summarize and present clinical pharmacology data to project teams, investigators and to senior management.

Qualifications:

A Ph.D. or equivalent in Pharmacokinetics, Pharmaceutical Sciences, or related discipline with at least seven years of industry and/or related post-doctoral experience is required.

Strong communication skills with the ability to convey pharmacology data to cross functional teams, senior management and external investigators.

Prior experience with NDA/BLA/MAA filings is desirable and prior experience with health authority and authoring responses required.