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Clinical Pharmacologist (Associate Director/Director)

Clinical Pharmacologist (Associate Director/Director)

 

Location: Malvern, PA/ Remote

Job Purpose:

 

This position is responsible for leading multiple facets of the company’s Clinical Pharmacology strategy, activities, ensuring adherence to study timelines, budgets, and applicable FDA/ICH/NIH guidelines to support product approvals.

Responsibilities:

  • Develop and implement the Clinical Pharmacology strategy for the company’s product portfolio, including design and execution of clinical pharmacology studies, data analysis, internal decision making, and external regulatory interactions.

  • Develop and implement pharmacokinetic, pharmacodynamic, and drug interaction studies to support overall development and regulatory submissions including marketing approval.

  • Provide input and oversight to pharmacokinetic and pharmacodynamic modeling required to support development and approval of company’s products.

  • Lead and supervise external consultants and vendor performing project level activities, including pharmacokinetic and pharmacokinetic/pharmacodynamic modeling.

  • Lead and supervise the external development of clinical bioanalytical methods, qualification, and validation in conjunction with external experts and qualified CROs.

Accomplishments:

 

Success in this role will provide Uniquity with efficient design and execution of pharmacokinetic and Pharmacodynamic modeling, along with the data analysis required to support the rapid development of our product portfolio

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