Associate Director, Clinical Development (Consultant/Contract - Hybrid)
Redwood City, CA
Hybrid/Remote (Bay Area)
Position Summary
The Associate Director of Clinical Development will play a key role in planning and executing clinical trials while providing strategic input into clinical development programs. This position requires a combination of scientific expertise, project management skills, and leadership capabilities.
Job Responsibilities
- Report to a senior member of the Clinical Development team who has direct responsibility for the overall research strategy and clinical development activities for the urticaria and stem cell programs.
- Lead the design, implementation, and execution of clinical trials from Phase I-III.
- Participate in and/or lead cross-functional matrix team meetings including stakeholders from clinical operations, medical affairs, regulatory affairs, and biostatistics.
- Develop and review clinical trial protocols, informed consent documents, and other study-specific plans and essential study materials.
- Collaborate with study team, investigators, and study sites to ensure trials are conducted according to protocol, GCP guidelines, and regulatory requirements.
- Monitor trial progress, timelines, and budgets while implementing risk mitigation strategies.
- Responsible for clinical aspects of data review and cleaning of key studies in the urticaria and stem cell programs.
- Review and analyze clinical trial data, safety information, and study metrics.
- Generate study reports, presentations, and publications to communicate findings to internal and external stakeholders.
- Prepare and/or contribute to clinical study-related and other regulatory documents (e.g., IBs, ICFs, SAPs, Data Management Plans, briefing books).
Strategic Leadership
- Contribute to clinical development plans and product development strategies.
- Provide scientific and medical expertise to cross-functional teams.
- Mentor and guide clinical research associates and other team members.
- Participate in the selection and management of CROs and vendors.
- Support regulatory interactions and documentation preparation.
Cross-functional Collaboration
- Work closely with Clinical Operations, Biostatistics, Data Management, Medical Writing, Translational, Regulatory Affairs, Technical Operations, and other functional teams to support successful execution of clinical development strategy.
- Engage with Key Opinion Leaders and clinical investigators.
- Lead strategy and authoring of clinical portions of regulatory submissions, responses to health authorities, and ethics committees.
- Support business development activities as needed.
Qualifications
Education and Experience
- Advanced degree required (MD, PhD, PharmD, or equivalent) in a relevant scientific or medical field.
- Minimum 5 years of clinical research experience, with at least 3 years in the pharmaceutical/biotech industry.
- Experience in immunology is strongly preferred.
- Demonstrated experience in clinical trial design, implementation, and execution with cross-functional study teams.
- Strong understanding of drug development processes, ICH-GCP guidelines, and regulatory requirements.
Skills and Competencies
- Excellent project management and organizational abilities.
- Strong analytical and problem-solving skills.
- Superior written and verbal communication skills.
- Proven leadership and team management experience.
- Ability to work effectively in a matrix organization.
- Proficiency in statistics, data analysis, interpretation, and relevant software.
Additional Requirements
- Bay Area preferable.
- Ability to travel if needed.
- Experience with electronic data capture systems.
- Knowledge of current industry trends and emerging technologies in clinical research.
- Track record of successful regulatory interactions.
