Vice President (VP) / Senior VP, Clinical Development

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

Lycia is seeking a highly motivated, innovative, and collaborative clinical development leader to join our team in advancing our pipeline of LYTAC degraders and help establish Lycia as the industry leader in endosomal-lysosomal degradation and delivery. The successful candidate is expected to have a strong drug development track record of advancing programs from early through mid- and late-phase clinical development. The candidate will be expected to drive the study design, study implementation, data analysis, safety monitoring of mid- and late-phase clinical trials in close partnership with early phase / translational development group and the research organization. The successful candidate will be instrumental in providing medical leadership and expertise to help guide the direction and actively support the advancement of our pipeline. The candidate will have a strong background in medicine, recognized expertise in their therapeutic area and strong leadership abilities, and a passion for driving innovation and excellence in a start-up biotech company. The role will report to the Chief Medical Officer.

Primary Responsibilities:

• Lead the development, execution, and interpretation of mid- to late-stage development plan in close collaborative partnership with early development / translational leader, cross-functional representatives, and research group to support clinical development and/or regulatory approval.
• Provide oversight of medical monitoring of clinical trials in partnership with CRO representatives and consultants to ensure pharmacovigilance and safety-related activities are appropriately managed according to GCP and regulatory guidelines in a timely manner.
• Provide medical support related to the development of medical and/or relevant scientific sections of clinical study and/or regulatory documents (e.g., study protocol, investigators brochure, informed consent forms, clinical study reports, statistical analysis plans, safety updates / annual safety reports, responses to Health Authorities and/or Ethics Committees / Institutional Review Committees). Participate in safety monitoring boards (e.g., Data Safety Monitoring Boards) as needed.
• Ensure compliance with regulatory requirements and guidelines throughout the product lifecycle, including interactions with regulatory agencies and participation in development of regulatory documents for submissions to Health Authorities.
• Contribute to the development and execution of program strategic plans and initiatives to maximize the value and impact of our portfolio.
• Collaboration with the Lycia Executive Committee members, early development / translational medicine leader, internal cross functional team members, as well as partner with contract research organizations (CROs), investigators and study site staff, and external consultants to advance multiple drug candidates, including into mid- and late-stage development.
• Working with cross-functional teams to develop program relevant documents (e.g., target product profiles, materials for internal governance, board meetings, publication planning material, advisory board documents) as needed to support program initiatives.
• Provide clinical and scientific leadership and guidance to internal teams and external stakeholders, including investigators, key opinion leaders (KOLs), and scientific advisors.
• Partner with the CEO, CMO, program and/or functional leads, on behalf of clinical development leadership, the planning and execution of advisory boards with external KOLs, in close coordination with the early translational medicine leader
• Build and maintain effective relationships with key external stakeholders, including healthcare providers, patient advocacy groups, and professional societies.
• Lead project teams in the successful implementation of key clinical development programs to ensure that program timelines and budgets are met.
• Ensures timely, clear, and accurate communication and interpretation of study results