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- Reporting to the Chief Medical Officer, the Vice President Clinical Operations is responsible for the clinical planning process and for all aspects of the management of clinical operations for our clinical trial portfolio. including resource and people management. This position is responsible for clinical trial conduct including project planning, budget management, timelines, resource management, site management, monitoring, study management, vendor management, and project operational support. Performs assigned responsibilities to ensure timely completion of department goals and objectives.
Responsibilities- Plan, implement and manage multiple global clinical trials.
- Manage and oversee the execution of clinical trial projects to support trials including both registration and post approval programs including; study design, clinical conduct/operations, data cleaning, statistical analysis and reporting of clinical trials.
- Propose, track and manage budgets for assigned projects.
- Oversee Clinical Operations staff to ensure that they are productively engaged with their work.
- Ensure all agreed goals and timelines are achieved through management of internal and external resources.
- Ensure that Clinical Operations SOPs reflect current clinical operations practices and are compliant with study protocols, federal and local regulations and standard operating procedures (SOPs) and GCPs.
- Responsible for managing a multidisciplinary team consisting of clinical operations team members, functional leads and external resources. Leads and/or participates in special projects as needed.
- Assign reports and allocate resources to meet company objectives.
- Manage the hiring, performance management, development and succession planning of staff.
- Acts on constructive feedback by using feedback from peers, Supervisors, and colleagues to improve performance and ability to provide constructive feedback to direct reports and colleagues. ∙
- Responsible for establishing partnerships with leading institutions in research (startups, academia, CRO) to collaborate on concept development and new technology adoption
Qualifications & Expereince- 12 years or more of relevant clinical industry experience (Biotech/pharma/CRO) within in the US, Europe and Asia (experience with China is preferred)
- Advanced degree in Life Science or related field, PhD. preferred
- Proven knowledge of, or experience with, clinical trial development process in Immunology or related field
- Must have a track record of strong leadership including recruitment and staff management
- Must have excellent communication skills (verbal, written and presentation abilities)
- Demonstrated vendor management experience
- Knowledge of ICH/GCP and regulatory guidelines/directives
- This role will require approximately 20% of travel, domestic & international.
$300,000 - $340,000 a year
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