VP R&D| First-in-Class Nerve Regeneration Therapy | Maxonis
Join Maxonis, a regenerative biotech company developing a first-in-class therapy to actively induce nerve repair and functional recovery in peripheral nerve and spinal cord injuries. We are seeking a VP R&D to lead our program through IND-enabling development and into first-in-human clinical trials.
About Maxonis
Maxonis is advancing afirst-in-class regenerative therapy designed to enhance nerve repair and expandtreatment options in peripheral nerve injury (PNI) and spinal cord injury (SCI).
Ourlead program, LDP-916, is a locally administered therapeutic currently inpreclinical development, combining a proprietary formulation approach aimed atovercoming the biological limitations of existing treatments.Maxoniswas founded by Itay Itzhaky (serial biotech entrepreneur; Colbar – $170M exitto J&J, Datum Dental – $100M+ exit) and Prof. Shimon Rochkind, MD, PhD(120+ publications, 4,200+ citations), and is backed by a global patent portfolio and robustpreclinical validation.Basedin Ness Ziona, Israel
Key responsibilities
- Lead the R&D team - setting scientific direction and execution priorities
- Define and drive the overall development strategy toward IND and clinical trials
- Lead drug product development and analytical development, including final formulation, stability, manufacturability and analytical characterization
- Define and lead the analytical development strategy for a complex, multi-component drug product
- Design and implement release, in-process, and characterization assays to support CMC and regulatory requirements
- Manage external partners (CDMOs and CROs) with clear deliverables and timelines
- Ensure alignment with FDA/EMA expectations and ICH guidelines towards IND submission
- Drive the program toward first-in-human clinical trials
Qualifications
- PhD (or equivalent) in pharmaceutical sciences, chemistry, biomaterials, or related field
- Proven track record advancing drug products frompreclinical to IND — peptide-based experience a strong advantage
- Strong experience in drug product development and CMC
- Deep experience in analytical method development for complex or combination drug products, including peptides – strong advantag
- Familiarity with ICH guidelines, GMP requirements, regulatory expectations, and quality system
- Proven ability to leadscientific teams and drive rigorous execution in a fast-moving environment