VP, Translational Medicine / Head, Clinical Pharmacology
Our client is a biotechnology company. They have asked us to assist them in a search for a VP, Translational Medicine / Head, Clinical Pharmacology.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Holds accountability for the clinical pharmacology strategy for the company’s pipeline, including design and implementation of program specific clinical pharmacology studies, data analysis, internal decision points, and external regulatory interactions.
- Leads nonclinical drug safety evaluation and development and implementation of a biomarker strategy for precision small molecules.
- Develops and executes scientifically rigorous strategies to inform drug discovery, development and regulatory decisions through all phases of drug development.
- Demonstrates drive, visibility and influence in key company decisions including development candidate selection, patient dosage selection, clinical strategy, and regulatory filing strategy.
- Manages and holds accountability for pharmacokinetic, pharmacodynamic, drug interaction, and anti- drug antibody data for all clinical trials.
- Leverages internal and external expertise and your own network to draft, plan, implement, and execute against organizational objectives.
- Actively partners with Clinical Development, Clinical Operations, and CMC functions in driving asset and company strategy to fruition.
- Oversees CRO selections, mentorships, and activities, builds external consultant networks and sets the right balance of internal versus external capabilities.
- Contributes to driving the shape of global regulatory filings including preparation of regulatory documentation and active participation in meetings with regulatory agencies.
- A PhD and/or MD is required.
- Requires experience in one or preferably more of DMPK, clinical pharmacology, pharmacometrics, nonclinical toxicology and pharmaceutics disciplines.
- Must have at least 10 years of relevant and current technical and leadership experience.
- Requires experience managing and applying pharmacometric approaches to support research and development.
- Must have excellent quantitative skills and a vision to leverage the science of dosage projection/simulation, drug-drug interactions, drug transporters, quantitative systems pharmacology, mechanistic toxicology risk assessment, and pharmaceutics in a cutting-edge discipline.
- Requires documented experience in the drug development process including multiple regulatory submissions.
- Must have outstanding interpersonal and communication skills both written and oral.
- Must have the ability to communicate complex information succinctly.
- Excellent analytical and problem-solving skills and ability to manage multiple projects and initiatives simultaneously in a fast-paced environment is required.
- Requires effective skills directed toward driving teamwork, accomplishing results, influencing, and resolving problems across internal and external project teams.
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.
Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.