Associate Director Of Clinical Development

Company: EPM Scientific - Phaidon International
Location: Redwood City
Posted on: April 14, 2025

Job Description:

We have a current opportunity for an Associate Director Of Clinical Development on a contract basis. The position will be based in Redwood City. For further information about this position please apply.Position SummaryThe 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.
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Keywords: EPM Scientific - Phaidon International, Pleasanton , Associate Director Of Clinical Development, Executive , Redwood City, California