Associate Director Of Clinical Development

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

• Will 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.
• - Will lead the design, implementation, and execution of clinical trials from Phase I-III
• -Will 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 required
• - Minimum 5 years of clinical research experience, with at least 3 years in 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