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