Lycia Therapeutics

Vice President

• 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

Vice President, Head – Nonclinical Development

• 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 to facilitate productive discussion and effective decision making.
• May 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 culture.
• Contribute to the pipeline strategy, including input on program prioritization, portfolio trade-offs, and organizational build-out of the clinical development function as Lycia scales.

Vice President – Senior VP, Clinical Development

Clinical Operations

• Responsible for all functional activities related to execution of Clinical Trials.
• Lead and oversee a team of internal and external clinical project managers/specialists to meet individual clinical trial objectives and corporate goals.
• Provide operational expertise to project teams.
• 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 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.

Vice President, Head – Nonclinical Development

Vice President – Senior VP, Clinical Development

Senior Director – Clinical Operations