Description
We have a current opportunity for a 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 Summary
Job Responsibilities
Qualifications
- 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