Senior Vice President, Translational Science

4:59 Initiative; Berkeley (CA); On-site; USD 250,000 - 350,000; Full time

Job summary

4:59 Initiative in Berkeley seeks a senior translational scientist to define and lead translational strategy for drug programs, from discovery through early clinical development. You will guide dose selection, endpoints, and readouts, partner with the CSO and CDO, and shape regulatory interactions while building a high-performing translational science team.

The role requires a Ph.D. or MD/PhD, 15+ years in biotech/pharma, and a proven track record moving programs to clinic with strong PK/PD and

Qualifications

• Ph.D. or MD/Ph.D. in a relevant scientific discipline.
• 15+ years of drug development experience in biotech or pharma.
• Proven track record taking programs from preclinical to Phase 1/2 in patients.
• Accelerated at least one program to the clinic.
• Deep small molecule drug development experience including PK, pharmacology, toxicology and IND path.
• Experience across multiple therapeutic areas; renal experience not required but ideal.
• Track record of building, managing and developing teams, and managing CROs.
• Strong scientific judgment to make decisions on incomplete data.
• Excellent communication with scientific, executive, Board and investor audiences.
• Trusted thought partner to senior leadership teams.
• Preferred: Experience in rare diseases, genetic or chronic diseases with surrogate endpoints.
• Biomarker strategy experience including imaging biomarkers or regulatory biomarker qualifications.
• Direct experience leading regulatory interactions including pre-IND with FDA.
• Hands-on experience designing and running Phase 1/2 studies with clinical teams.
• Experience with protein folding correctors, potentiators or ion channel drugs (e.g., CF).
• Experience building a function at an early-stage, venture-backed company.

Responsibilities

• Define and lead the translational strategy for Renasant's corrector and potentiator programs from development candidate nomination through Phase 1/2.
• Serve as the translational science voice guiding go/no go decisions across biology and related strategies.
• Own the translational strategy to bring molecules from discovery into clinical development.
• Partner with the Chief Discovery Officer and Chief Medical Officer on dose selection, endpoints and readouts.
• Contribute to regulatory strategy and represent the science in pre-IND and other interactions with FDA and other agencies.
• Lead and develop a high-performing translational science team.
• Serve as a thought partner to the CSO, CDO, CEO and senior leadership and work with research leadership and the Board.
• Communicate program strategy and data clearly to investors, partners and the Board.

Skills

Leadership

Strategic thinking

Communication skills

Regulatory strategy

Stakeholder management

Education

Ph.D. or MD/Ph.D. in relevant field

Job description

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.