Vice President, Head, Nonclinical Development

Lycia Therapeutics•South San Francisco, CA

3d•Onsite

About The Position

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. 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.

Requirements

Ph.D. in toxicology, pharmacology or other pharmaceutical or biological science
10+ years of industry experience beyond postdoctoral work in drug development
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.

Responsibilities

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