Associate Director / Director, Clinical Science

Lycia Therapeutics, Inc. is a biotechnology company leveraging its lysosomal targeting chimera (LYTAC) platform from Founder and Chemistry Nobel Laureate 2022, Carolyn Bertozzi, to discover and develop first-in-class therapeutics that degrade extracellular and membrane-bound proteins. Lycia’s next generation degraders harness the cell’s endogenous lysosomal trafficking and degradation machinery with the potential to degrade targets previously considered to be intractable, across a spectrum of indications. After raising $105 million in capital in 2021, Lycia is advancing an internal pipeline of novel degraders and has entered a strategic collaboration with Eli Lilly to address key unmet medical needs. 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 Role:
Lycia Therapeutics is seeking a Director or Associate Director of Clinical Science who will play a critical role in the design, execution, and analysis of clinical trials of clinical stage assets. This position is responsible for driving clinical development activities, ensuring scientific integrity, and collaborating with cross-functional teams to advance innovative therapies through all stages of clinical development. At Lycia, you will be instrumental in shaping the development trajectory of our innovative therapeutic candidates and bringing transformative therapies to patients in need.

Key Responsibilities:

• 
  
Clinical Development Leadership
• Provides clinical and scientific contributions to the clinical development plans, including the designing and implementation of clinical studies.
• Contribute to the development of clinical strategies in alignment with program goals.

Protocol Development and Study Oversight
• Responsible for development of study protocols, case report forms (CRFs), consent forms, investigators brochure, development of charters (e.g., Independent Data Monitoring Committee, Safety Monitoring Committee) and other essential trial documents.
• Contributes to the development of training modules, Investigator webinars, Investigator meetings, and CRA/staff training.
• Ensure compliance with ICH-GCP guidelines, regulatory requirements, and internal policies.
• Act as a medical monitor or scientific liaison during studies, depending on qualifications, to partner with investigators, study site staff, and CRO partners,

Data Analysis and Reporting
• Analyze clinical data to evaluate safety, efficacy, and pharmacological properties of investigational products.
• Uses available tools to monitor study conduct (screening, randomization, adjudication, retention).
• Participates in and leads safety and data cleaning activities (medical listing review, periodic safety review, preparation for IDMC review).
• Provide input on the quality control of tables, listings, and graphs for database lock.
• Collaborate with biostatisticians to interpret results and prepare clinical study reports for regulatory submissions.
 Cross-Functional Collaboration
• Work closely with clinical operations, regulatory affairs, biostatistics, and other cross-functional teams to ensure seamless trial execution.
• Build relationships and engage with external stakeholders such as Key Opinion Leaders (KOLs), investigators, and regulatory authorities as needed to help advance the development of investigational products.

Regulatory Submissions
• Support the preparation of regulatory documents (e.g., INDs, DSURs, NDAs) by providing clinical expertise.
• Ensure that all clinical trial data meet regulatory standards for safety and efficacy.

Team Management and Mentorship
• Depending on candidate’s experience level, opportunity to actively mentors and coaches junior cross-functional team members.

Requirements:

• Director: MD/PhD or equivalent advanced degree in life sciences or related field.
• Associate Director: Advanced degree (PhD, PharmD, RN, Master’s) in life sciences; MD preferred but not required.

Experience
• Minimum 5–8 years (Director) or 3–5 years (Associate Director) of experience in clinical research or drug development within biotech/pharma settings.
• Expertise in allergy, immunology or autoimmune therapeutic areas is highly desirable.

Skills
• Strong understanding of drug development processes from preclinical to Phase 2 clinical development is desirable.
• Proficiency in analyzing and interpreting complex clinical data.
• Excellent communication skills for cross-functional collaboration and external stakeholder engagement.

Competencies and Capabiliti