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 SummaryLycia 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 approvalProvide 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 mannerProvide 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 neededEnsure 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 AuthoritiesContribute to the development and execution of program strategic plans and initiatives to maximize the value and impact of our portfolioCollaboration 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 developmentWorking 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 initiativesProvide clinical and scientific leadership and guidance to internal teams and external stakeholders, including investigators, key opinion leaders (KOLs), and scientific advisorsPartner 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 leaderBuild and maintain effective relationships with key external stakeholders, including healthcare providers, patient advocacy groups, and professional societiesLead project teams in the successful implementation of key clinical development programs to ensure that program timelines and budgets are metEnsures timely, clear, and accurate communication and interpretation of study results to facilitate productive discussion and effective decision makingMay serve as the company representative or subject matter expert in meetings with external stakeholders (business partners/collaborators, vendors, investigators, regulatory agencies, patient advocacy organizations, payers)Member of clinical and scientific leadership team that will work effectively and collaboratively with other departments and cross-functional teams, and contribute to building a positive, team-oriented cultureContribute to the pipeline strategy, including input on program prioritization, portfolio trade-offs, and organizational build-out of the clinical development function as Lycia scalesQualifications:MD or equivalent with training/experienceMinimum of 15+ years of clinical development experience; small to midsize biotech company experience strongly preferredProven 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 GCP regulations; experience in NDA and/or BLA submissions is preferredExperience in supporting identification, working with and oversight of CROs and vendors a track record of timely and successful delivery of clinical studiesExperience collaborating and managing consultantsMust thrive working in a fast-paced innovative environment while remaining flexible, proactive, resourceful, and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans and recommendationsDemonstrated 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 mitigate risksDemonstrated 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 applicableAbility to build trust and strong collaborative relationships with both internal and external stakeholdersFlexible and dynamic interpersonal approach, entrepreneurial by nature, a collaborative team player who works well with other clinicians, scientists, managers, peers, and staffOutstanding organizational and interpersonal skills, and outstanding ability to manage relationships and influence othersExcellent strategic thinking, problem-solving, and analytical skillsExcellent written and verbal communication skillsExperience in immunology & inflammation and autoimmune indications, preferredWillingness to be both a strategic leader, critical thinker, and hands-on problem solver and willing to operate and execute at all levelsStrong 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 functionsHighly organized and detailed orientedPrepare and attend internal governance meetingsMake meaningful contributions to business development related activities as neededWillingness to travel up to 15% of the timeWe are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.Lycia and other biotech companies have recently noticed an increase in email and social media scams targeting job candidates in our industry. Please note Lycia will post any legitimate job openings directly on our website or through our recruitment partner, Lever. If you wish to verify the legitimacy of a job opening, you may contact us.We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.The expected base salary range for this role is $360,000-$420,000. We encourage candidates of all levels to apply as there is often flexibility on job title and responsibilities. Compensation will be based on a variety of factors, including experience, qualifications and internal equity. Lycia offers a competitive employment package that includes an annual bonus, equity, and a generous benefits package.