What are the responsibilities and job description for the Director Clinical Development position at EPM Scientific?
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
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