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).

• 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.

• 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

• 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

We offer our employees comprehensive benefits.

Jasper is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other characteristic protected by applicable law.

Company Values:

·       Respect

·       Collaboration

·       Integrity

·       Responsible

·       Excellence

·       Acknowledgment

Mission:

Our mission is to make safer and potentially curative therapy possible for more patients in need. We are bringing together a team of high performing biotech professionals, leading academic institutions and a strong syndicate of healthcare-focused investors to achieve our vision