Our client is a clinical-stage biotechnology company. They have asked us to assist them in a search for a Vice President/Senior Vice President, Translational Medicine.  

Major tasks and responsibilities include:

• Is responsible for the translational medicine and clinical pharmacology functions and generates the integrated translational medicine and clinical pharmacology strategy for the nephrology pipeline programs across development stages with a strong focus on early clinical translation.
• Manages a team of translational scientists who serve on cross-functional development and project teams who drive our translational research strategy.
• Is a member of the cross-functional Development Review Committee (DRC) responsible for driving development strategy for all pipeline programs.
• Defines scientific strategies for key translational activities including clinical dose selection, principles for dose optimization, patient selection/stratification, demonstration of clinical target engagement, proof of mechanism and biomarker strategies.
• Designs and implements pharmacokinetic (PK), pharmacodynamic (PD), and clinical pharmacology strategies, including the application of population PK, PK/PD models and simulations and pediatric bridging strategies.
• Plays a key role in patient and indication selection and prioritization for our pipeline programs through interaction with the research, clinical development and market research groups and the global product teams.
• Collaborates with the company’s computational biology and bioinformatics team, leveraging public and proprietary multi-omic CKD patient cohort data-bases rich in genomic, transcriptomic, and clinical annotations, with retained bio-samples for exploratory biomarker characterization to support our precision medicine approach to drug development.
• Contributes to as author/reviewer of relevant regulatory submission documents and provides strategic guidance on regulatory interactions relating to translational medicine and clinical pharmacology aspects of drug development.
• In collaboration with the clinical team, defines and implements precision medicine strategies in clinical study protocols to achieve rapid proof of concept and clear path to registration in molecularly defined patient populations.
• Establishes and collaborates with a network of leading nephrology key opinion leaders and disease area experts.

 
We seek candidates with the following qualifications:

• A Medical degree, PhD, or MD/PhD is required.
• Must have at least 12 years of drug discovery and development experience in the biotechnology/pharmaceutical industry, including direct experience in translational medicine and clinical pharmacology in early-stage development.
• Requires expert knowledge and understanding of nephrology, including rare and genetic kidney diseases and experience with precision medicine development strategies.
• Must be a strategic translational scientist and drug developer with a successful track record in nephrology as demonstrated by successful IND filings, Phase 1 proof of mechanism and clinical PoCs.
• Proven experience in leading high performing teams is required.
• Must be a team player and leader who is also willing to roll-up your sleeves to get the job done.
• Requires strong interpersonal and communication skills both written and oral and the ability to communicate complex scientific information clearly and succinctly.
• Must be passionate about and committed to delivering novel therapies to impact the huge unmet need in kidney disease patients.

 
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 and Forbes' list of Top 200 Best Executive Recruiting Firms.