Vice President, Head, Nonclinical Development

South San FranciscoFull-Timeexecutive

OtherDevelopment

0 views0 saves0 applied

Apply Now

Quick Summary

Overview

Technical Tools

mentoring

Lycia Therapeutics is a biotechnology company using its proprietary lysosomal targeting chimera (LYTAC) platform to discover and develop best-in-class therapeutics that degrade extracellular and membrane-bound proteins. These proteins drive a wide range of difficult-to-treat diseases, including autoimmune and inflammatory conditions. Lycia was established in 2019 in collaboration with academic founder and Nobel Laureate Carolyn Bertozzi, Ph.D., professor of chemistry and HHMI investigator at Stanford University. In May 2024, Lycia Therapeutics completed a $106.6 million Series C financing to advance its pipeline of LYTAC extracellular protein degraders to the clinic. Lycia is headquartered in South San Francisco.

Visit https://lyciatx.com/ for more information.

Position Summary

Highly motivated, creative scientific leader to advance our pipeline of LYTAC degraders and help establish Lycia as the industry leader in endosomal-lysosomal degradation and delivery. A successful candidate can effectively work cross-functionally and has a strong drug development track record of advancing programs from target discovery through IND/clinical stage.

Fully accountable for building and overseeing the nonclinical/translational strategy for company programs. Responsible for the design and execution of nonclinical (safety/toxicology, bioanalysis, PK/PD/ADME) plans to efficiently advance molecules at all stages of drug development; including non-GLP and GLP-compliant studies

Build the nonclinical development function with the requisite scientific, safety/toxicology, PK/ADME and regulatory expertise

Guide early clinical dosing strategy by integrating relevant nonclinical data

Work in close collaboration with the Lycia Leadership team and project team leads, contract research organizations (CROs) and external consultants to advance multiple drug candidates into and through clinical development

Serve as a departmental representative and/or project leader for pipeline programs

May also support clinical pharmacology activities for development programs

Ensures timely, clear and accurate communication and interpretation of study results to facilitate productive discussion and effective decision making

Coordinate and contribute to the preparation of documents required for regulatory meetings and submissions

May serve as the company representative or subject matter expert in meetings with external stakeholders (business partners/collaborators, vendors, investigators, regulatory agencies)

Maintain a current understanding of drug development and translational science literature and methodology relevant for the advancement of drug discovery projects

Member of scientific leadership team that will work effectively and collaboratively with other departments and cross-functional teams, and contribute to building a positive, team-oriented culture

Requires a Ph.D. in toxicology, pharmacology or other pharmaceutical or biological science

10+ years of industry experience beyond postdoctoral work in drug development and 5+ years of successful functional area management/ leadership

Experience and accomplishment in progressing large molecule, small molecule, and antibody drug conjugate candidates from research through development (resulting in successful INDs and/or BLA/NDA/MAAs).

Strong knowledge of nonclinical drug development, FDA and ICH guidelines and GLP/GMP regulations

Experience in designing, conducting and interpreting nonclinical pharmacology, PK/PD/ADME and toxicology studies

Experience in working with external CROs with timely and successful delivery of studies and well-written deliverables; experience collaborating and managing consultants in various areas of nonclinical sciences

Understanding of CMC, QA, clinical and regulatory stages to effectively support nonclinical and project activities throughout development

Experience in writing nonclinical sections of regulatory documents and direct interaction with the FDA/health authorities

Demonstrated ability to build and lead high functioning, collaborative and driven teams (both internal and external), and mentoring direct reports and/or junior cross-functional colleagues as applicable

Excellent strategic thinking, problem-solving and analytical skills

Excellent written and verbal communication skills

Ability to build collaborative relationships both internally and externally

Flexible and dynamic interpersonal approach, entrepreneurial by nature, a collaborative team player who works well with physicians, scientists, managers, peers, and staff

Ability to manage in a consensus environment through teamwork, trust and shared expectations, influencing strategic direction of complex global regulatory issues, solicit information, listen well, persuade others, make important decisions and shape outcomes.