Senior Director, Clinical Development

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).

Summary

• Reporting to the SVP of Clinical Development, the Senior Medical Director leads the direction, planning, execution, and interpretation of clinical trials of one or more Phase 1 through 3 clinical development programs at Jasper, focused on advancing Briquilimab and other novel stem and mast cell targets and molecules. Participates in and leads cross-functional teams to generate, deliver, and disseminate high-quality clinical data supporting overall product scientific and business strategy. 

Responsibilities

• Build strategic and coordinated clinical development plans which are aligned with business objectives and overall corporate strategy. 
• Leads and demonstrates ownership of the design and implementation of multiple clinical development protocols of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, markets, business operations, and emerging issues. Oversees project-related education of investigators, study site personnel, and Jasper study staff. 
• Leads the Clinical Sub team (CST, a cross-functional matrix team, reporting to the Program Team; is seen as the clinical designee to the PT, driving team alignment and decision making across functions and ensuring smooth communication between the PT and the Global Franchise Committee (GFC) as well as the Clinical Development line function.  
• Has overall responsibility for leading clinical study teams, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for ensuring agreed-upon study enrollment and overall timelines for key deliverables.  
• Primary responsibility for and ownership of design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents. 
• Work collaboratively with Medical and/or Scientific Directors and Clinical Scientists working on the same or related programs. 
• Serves as an in-house clinical expert for one or more molecules and diseases in the therapeutic area, coordinating and leading appropriate scientific and medical activities with internal stakeholders as they relate to ongoing projects.  
• May participate in or lead clinical development contributions to due diligence or other business development activity. As required by program needs, contributes in partnership with Research colleagues to design and implementation of translational strategies. 
• Acts as clinical lead and actively solicits opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate. 
• Stays informed of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. May represent Jasper at key external meetings. 
• Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions. 

Requirements

• Medical Doctor (M.D.) or non-US equivalent of M.D. degree, PhD or PharmD required.   
• At least 5-10 years of experience in the pharmaceutic or biotech industry required, experience in small to midsize biotech preferred.  
• Proven track record of leadership in clinical trial design and execution including both early (Phase 1) and later stage (Phase 2 and 3) development experience in the biotech or pharmaceutical industry required.  
• Proven leadership skills to lead a global cross functional team