Executive Director, Clinical Pharmacology
Our client is a biotechnology company. They have asked us to assist them in a search for an Executive Director, Clinical Pharmacology.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Accounts for the clinical pharmacology strategy for our pipeline, including design and implementation of program specific clinical pharmacology studies, data analysis, internal decision points, and external regulatory interactions.
- Works collaboratively to lead the development and implementation of clinical pharmacokinetic, pharmacodynamic, and modeling and simulation strategies and execution to inform clinical 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 accounts for pharmacokinetic, pharmacodynamic, drug interaction, and anti-drug antibody data generation, analysis and interpretation for all clinical trials.
- Leverages internal and external expertise and your own network to draft, plan, implement, and execute against organizational objectives.
- Partners with Clinical Development, Clinical Operations, Nonclinical Development, Pharmaceutical Sciences, and Discovery and Translational Sciences functions in driving asset and company strategy to fruition.
- Builds external consultant networks to set the right balance of internal versus external capabilities.
- Drives the shape of global regulatory filings including preparation of regulatory documentation and active participation in meetings with regulatory agencies.
- A PhD or equivalent is required.
- Must have experience in one or preferably more of DMPK, clinical pharmacology, pharmacometrics, and pharmaceutics disciplines with at least 10 years of relevant and current technical and leadership experience.
- Requires excellent quantitative skills and a vision to leverage the science of dosage projection/simulation, quantitative systems pharmacology, mechanistic toxicology risk assessment, and pharmaceutics in a cutting-edge discipline.
- Experience with monoclonal antibody development is strongly preferred.
- Requires documented experience in the drug development process including multiple regulatory submissions.
- Must have outstanding interpersonal and communication skills both written and oral with 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 are required.
- Must have effective skills directed toward driving collaboration, achieving results, influencing, and resolving conflicts 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.