Associate Director/Director, Clinical Science

• 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

• 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.

• Director: MD/PhD or MD 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.

• 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.

• 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.

• 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.

• 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%)

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.