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.
The Senior Director/Executive Director Clinical Operations will be responsible for responsible for all functional activities related to execution of Clinical Trials. The incumbent will lead and oversee a team of internal and external clinical project managers/specialists to meet individual clinical trial objectives and corporate goals as well as providing operational expertise to project teams.
Primary Responsibilities:
- Directs, supervises and manages all aspects of clinical trials to ensure that corporate and department goals/objectives for clinical development programs are met on time and within budget.
- Interacts with multidisciplinary teams in a matrix environment, developing resourcing, budgeting, financial and strategic planning for clinical programs/studies
- Create and execute clinical operational strategic plans in line with product strategy and resource allocation.
- Responsible for, as directed, strategy and clinical operation sections of regulatory documents including data summarization, protocols, Investigator Brochures, IND annual reports, and others as needed or requested.
- Prepare and present clinical development trial updates to senior management, review any potential issues and propose any mitigations/recommendations.
- Develop study feasibility, cost estimates, input into contracts, work/change orders and analyze tools and processes to support outsourcing efforts.
- Build, develop and train internal staff and external vendors, structure department for enhancing efficiency, and create a highly engaged work environment for attracting and retaining highly qualified clinical operations professionals.
- Develop and ensure compliance with SOPs and guidelines, FDA regulations and current ICH GCP guidelines.
- Oversee and maintain the relationships with Contract Research Organizations and investigative sites,
- Participate on project teams and study teams as needed or requested.
- Maintain a high level of professional expertise through familiarity of clinical literature, knowledge of therapeutic area, current medical practice and pharmaceutical regulations.
Additional Expectations
- Although a remote position, it may be necessary to travel to corporate headquarters up to 2 times per year.
- Ability to travel to clinical sites or to the CRO, as necessary to support trial management.
Qualifications:
- B.A/B.S required; M.S., PhD, PharmD, MD or other related advanced scientific degree strongly preferred.
- Minimum of 10 years for senior director and minimum of 20 years for executive director with progressive advancement within clinical operations in the pharmaceutical/biotech industry.
- Ability to build collaborative relationships with investigators, vendors, and individuals at all levels of the organization.
- 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 clinical operations issues, solicit information, listen well, persuade others, make important decisions and shape outcomes.
We 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.
