Job Description

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.

Minimum Requirements:

Education
• 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.
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 Capabilities
• 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.
Location & Travel
• 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%)