Lycia Therapeutics · 3 hours ago
Associate Director/Director, Clinical Science
South San Francisco
Full-time
Hybrid
Senior Level, Lead/Staff
$190K/yr - $280K/yr
3+ years expLycia Therapeutics is a biotechnology company focused on developing innovative therapeutics using its proprietary LYTAC platform. The Director of Clinical Science will lead clinical development activities, ensuring scientific integrity and collaborating with cross-functional teams to advance clinical trials of therapeutic candidates.
BiotechnologyHealth CareLife Science
Responsibilities
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
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
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
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
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
Depending on candidate’s experience level, opportunity to actively mentors and coaches junior cross-functional team members
Qualification
Required
MD/PhD or MD or equivalent advanced degree in life sciences or related field for Director position
Advanced degree (PhD, PharmD, RN, Master's) in life sciences for Associate Director position; MD preferred but not required
Minimum 5–8 years of experience in clinical research or drug development within biotech/pharma settings for Director
Minimum 3–5 years of experience in clinical research or drug development within biotech/pharma settings for Associate Director
Strong understanding of drug development processes from preclinical to Phase 2 clinical development
Proficiency in analyzing and interpreting complex clinical data
Excellent communication skills for cross-functional collaboration and external stakeholder engagement
Advanced knowledge of clinical trial design methodologies, biostatistics, and regulatory requirements
Ability to anticipate risks and develop mitigation strategies during trial execution
Demonstrated ability to lead cross-functional teams in a fast-paced environment while managing multiple priorities
Flexible and dynamic interpersonal approach, entrepreneurial by nature, a collaborative team player who works well with physicians, scientists, managers, peers, and staff
Creates an environment for open scientific debate, integrates information, and drives to decisions or actions where no process/precedent exists
Preferred
Expertise in allergy, immunology or autoimmune therapeutic areas is highly desirable
San Francisco Bay Area preferred; Ability to work on-site (Lycia South San Francisco office) at least 2-3 full days per week
Business travel as needed (may vary with time, but is not expected to exceed 15%)
Benefits
Annual bonus
Equity
Generous benefits package
Company
Lycia Therapeutics
Lycia Therapeutics is a biotechnology company that focuses on developing technology that utilizes lysosome-targeting chimeras.
11-50 employees
Funding
Current Stage
Growth StageTotal Funding
$226.6MKey Investors
Venrock Healthcare Capital PartnersRedmile GroupVersant Ventures
2024-05-13Series C· $106.6M
2021-09-09Series B· $70M
2020-06-09Series A· $50M
Leadership Team
Aetna Wun Trombley
Chief Executive Officer
Recent News
2025-04-02
2025-04-02
2025-02-12
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