Senior VP, Clinical Development & Strategy

Lycia Therapeutics, Inc.; South San Francisco (CA); Sur place; USD 360 000 - 420 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Equity

Generous benefits package

Résumé du poste

Lycia Therapeutics, Inc. is seeking an experienced clinical development leader to advance LYTAC degraders through mid- and late-stage development.

The role requires heading study design, implementation, data analysis, and safety monitoring in collaboration with translational and research teams, while guiding regulatory strategy and interactions with FDA/Health Authorities. The candidate should have a strong medical background with leadership abilities, a track record in Phase 2/3 trials, and

Qualifications

• 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 GCP regulations; experience in NDA and/or BLA submissions is preferred.
• 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.
• 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.
• Strong ability to communicate and establish effective working relationship with external stakeholders (e.g., investigators, collaborators, scientific advisors, CROs, and corporate partners).
• Willingness to travel up to 15% of the time.

Responsabilités

• Lead the development, execution, and interpretation of mid- to late-stage development plan to support clinical development and/or regulatory approval.
• Provide oversight of medical monitoring of clinical trials to ensure pharmacovigilance and safety activities follow GCP and regulatory guidelines.
• Provide medical support related to the development of regulatory documents (study protocol, investigators brochure, informed consent forms, CSRs, SAPs, safety reports).
• Ensure regulatory compliance throughout the product lifecycle and interact with Health Authorities as needed.
• Contribute to the development of program strategic plans and initiatives to maximize value of the portfolio.
• Collaborate with Lycia executives, cross-functional teams, CROs, investigators and external consultants to advance multiple drug candidates.
• Develop program documents (TPP, governance materials, board materials, publication plans) as needed.
• Provide clinical leadership to internal teams and external stakeholders including investigators and KOLs.
• Coordinate advisory boards with external KOLs in collaboration with translational medicine leadership.
• Build relationships with external stakeholders including healthcare providers and patient advocacy groups.
• Lead project teams to ensure timelines and budgets are met.
• Communicate study results clearly to facilitate decision making.
• May serve as company representative in meetings with external stakeholders.

Connaissances

Leadership

Clinical development

Regulatory knowledge

Cross-functional collaboration

Formation

MD or equivalent

Description du poste

Lycia Therapeutics, Inc. is seeking an experienced clinical development leader to advance LYTAC degraders through mid- and late-stage development.

The role requires heading study design, implementation, data analysis, and safety monitoring in collaboration with translational and research teams, while guiding regulatory strategy and interactions with FDA/Health Authorities. The candidate should have a strong medical background with leadership abilities, a track record in Phase 2/3 trials, and