Vice President, Clinical Pharmacology
Our client is a clinical-stage biotechnology company focusing on precision medicines for brain diseases. They have asked us to assist them in their search for a Vice President, Clinical Pharmacology.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Holds accountability for the overall clinical pharmacology strategy for the company portfolio.
- Designs and implements asset or program-specific clinical pharmacology studies, data analysis, internal decision points, and external regulatory interactions.
- Leads the development and implementation of pharmacokinetic, pharmacodynamic, and modeling and simulation studies and execution to inform clinical and regulatory decisions through all phases of drug development.
- Works closely with cross-functional teams to provide and source subject matter expertise in quantitative clinical pharmacology, non-clinical pharmacology, and non-clinical modeling to inform topics such as dose selection and schedule.
- Contributes to program strategies, study designs, protocol preparation, study execution, data review and analysis, study reports and regulatory document preparation.
- Collaborates with research and development teams and provides input into assay development as well as CRO and vendor selection and management.
- Represents non-clinical and clinical pharmacology teams during meetings and discussions with regulatory authorities.
- Guides the development of non-clinical and clinical pharmacology summary documents.
- Reviews literature and peer-reviewed publications to keep apprised of global regulatory developments in clinical pharmacology.
- Maintains a high standard for good laboratory and clinical practices, compliance, and ethical standards.
- Must have an MD or PhD in pharmaceutical sciences or pharmacology, or a PharmD with at least seven years of relevant clinical pharmacology experience within the pharmaceutical and biotechnology industry.
- Requires the proven ability to write, present, and discuss non-clinical and clinical pharmacology with internal and external stakeholders.
- Must have strong analytical skills and the ability to interpret complex nonclinical and clinical data sets.
- The proven ability to work in cross-functional teams and manage multiple projects is required.
- The ability to thrive in a fast-paced, evolving company is required.
- Must have a proven ability to work with a high level of integrity, accuracy, and attention to detail.
- Must be willing to work collaboratively by incorporating diverse perspectives and appropriately managing relationships.
- The demonstrated application of critical thinking skills is required.
- Requires the proven ability to prioritize and execute corporate objectives and goals.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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