Lycia Therapeutics

Vice President (VP) / Senior VP, Clinical Development

South San Francisco · Exec

Sponsorship not specified$360k-$420kDetected 70 days ago

GCPData AnalysisStatisticsProduct ManagementBusiness DevelopmentNegotiationClinical TrialsFDA RegulatoryPharmacovigilanceResearchExperimental DesignLeadershipCommunicationCollaborationProblem SolvingMentoringOrganizational Skills

About the role

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 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.

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.
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.
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
Lead project teams in the successful implementation of key clinical development programs to ensure that program timelines and budgets are met.
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.

Requirements

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.
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 mitigate risks.
MD or equivalent with training/experience
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 GCP regulations
Must 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 recommendations.
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 mitigate risks.
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 applicable.
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.

Nice to have

Minimum of 15+ years of clinical development experience
small to midsize biotech company experience strongly preferred.
Strong knowledge of nonclinical drug development, FDA, and ICH guidelines and GCP regulations
experience in NDA and/or BLA submissions is preferred.
Experience in immunology & inflammation and autoimmune indications, preferred.

Compensation

Participate in safety monitoring boards (e.g., Data Safety Monitoring Boards) as needed.

Benefits

Build and maintain effective relationships with key external stakeholders, including healthcare providers, patient advocacy groups, and professional societies.

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