Associate Director, Clinical Development (Consultant/Contract - Hybrid onsite)

Jasper is a clinical-stage biotechnology company developing briquilimab, a novel antibody targeting c-Kit (CD117) as a therapeutic for chronic mast and stem cell diseases. Jasper is currently conducting clinical studies of briquilimab as a treatment in patients with CSU or with CIndU and is initiating a clinical study in patients with asthma. Briquilimab is also currently in clinical studies as a treatment for patients with LR-MDS and as a conditioning agent for cell therapies for rare diseases. To date, briquilimab has a demonstrated efficacy and safety profile in more than 160 dosed participants and healthy volunteers, with clinical outcomes in CIndU, and as a conditioning agent in severe combined immunodeficiency (SCID), acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), Fanconi anemia (FA), and sickle cell disease (SCD).

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 
• - T