About this role
Responsibilities
Translational strategy and drug development
- Define and lead the translational strategy for Renasant's corrector and potentiator programs, from development candidate nomination through Phase 1/2.
- Serve as the company's translational science voice, guiding go/no go decisions across biology, translational and related strategies that support our programs
- Own the translational strategy to support bringing molecules from discovery into clinical development
- Partner with our Chief Discovery Officer and Chief Medical Officer on decisions related to dose selection, endpoints and other related readouts.
Regulatory and external engagement
- Contribute to regulatory strategy and represent the science in pre-IND and other interactions with FDA and other agencies.
Leadership
- Lead and continuously develop a highly performing translational science team.
- Serve as a thought partner to the CSO, CDO, CEO and senior leadership team and work closely with research leadership and the Board.
- Communicate program strategy and data clearly to investors, partners and the Board.
Qualifications
- Ph.D. or M.D./Ph.D. in a relevant scientific discipline
- 15+ years of drug development experience in biotech or pharma, with a proven record as a seasoned drug developer.
- Demonstrated success taking multiple programs or proofs of concept from preclinical development into Phase 1 or Phase 2 studies in patients.
- Has successfully accelerated at least one program to the clinic.
- Deep small molecule drug development experience, including pharmacokinetics, pharmacology, toxicology and the path to IND is required.
- Experience spanning multiple therapeutic areas; renal experience is not required but considered ideal.
- Track record of building, managing and developing teams, and managing external partners such as CROs.
- Strong scientific judgment, with the ability to make clear decisions on incomplete data.
- Excellent communication skills with scientific, executive, Board and investor
audiences.
- Has served as a trusted thought partner to senior leadership teams.
Preferred
- Experience in rare diseases, genetic or chronic diseases, including programs built on natural history data or surrogate endpoints.
- Biomarker strategy experience, including imaging biomarkers or regulatory biomarker qualifications.
- Direct experience leading regulatory interactions, including pre-IND meetings with FDA.
- Hands on experience designing and running Phase 1 and Phase 2 studies with clinical teams.
- Experience with protein folding correctors, potentiators or ion channel drugs, such as in cystic fibrosis.
- Experience building a function at an early-stage, venture-backed company.