Vice President (VP) / Senior VP, Clinical Development
- Compensation
- $360K–$420K / yr
- Location
- South San Francisco
- Work setup
- Hybrid
- Seniority
- C level
- Employment
- Contract
- Experience
- 15+ years
- Category
- Not specified
- Posted
Skills
Must have
- MD or equivalent with training/experience
- Minimum of 15+ years of clinical development experience; small to midsize biotech company experience strongly preferred.
- Proven track record of leadership in the successful development and implementation of Phase 2 and Phase 3 clinical trials to support regulatory submission (e.g., BLA, NDA).
- Experience in writing clinical sections of regulatory documents and direct interaction with the FDA/health authorities. Strong knowledge of nonclinical drug development, FDA, and ICH guidelines and GC
- Experience in supporting identification, working with and oversight of CROs and vendors a track record of timely and successful delivery of clinical studies.
- Experience collaborating and managing consultants.
- Must thrive working in a fast-paced innovative environment while remaining flexible, proactive, resourceful, and efficient. Excellent interpersonal skills, ability to develop important relationships w
- Demonstrated ability to translate strategy into action. Excellent analytical skills, ability to communicate complex issues in a simple way, and ability to orchestrate plans to resolve issues and mitig
- 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 applicab
- Ability to build trust and strong collaborative relationships with both internal and external stakeholders.
- Flexible and dynamic interpersonal approach, entrepreneurial by nature, a collaborative team player who works well with other clinicians, scientists, managers, peers, and staff.
- Outstanding organizational and interpersonal skills, and outstanding ability to manage relationships and influence others.
- Excellent strategic thinking, problem-solving, and analytical skills
- Excellent written and verbal communication skills.
- Experience in immunology & inflammation and autoimmune indications, preferred.
- Willingness to be both a strategic leader, critical thinker, and hands-on problem solver and willing to operate and execute at all levels.
- Strong ability to communicate and establish effective working relationship with external stakeholders (e.g., investigators, collaborators, scientific advisors, CROs, and corporate partners).
- Able to work in a small, nimble organization across key functions.
- Highly organized and detailed oriented.
- Prepare and attend internal governance meetings.
- Make meaningful contributions to business development related activities as needed.
- Willingness to travel up to 15% of the time.
Full description
Lycia Therapeutics (Nasdaq: LYCA) is a clinical-stage biotechnology company using its proprietary lysosomal targeting chimera (LYTAC) platform to discover and develop therapeutics that degrade extracellular and membrane-bound proteins. These proteins drive a wide range of difficult-to-treat diseases, including autoimmune, inflammatory, and allergic 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 October 2026, Lycia completed an initial public offering, and its common stock now trades on the Nasdaq Global Select Market under the ticker symbol “LYCA.” Lycia is headquartered in South San Francisco.
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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.