Director, Clinical Operations

  • Full-time

Company Description

Jasper Therapeutics is a publicly listed company with a lead clinical-stage program that is a first-in- class and potentially breakthrough antibody to safely replace chemo-radiation as a conditioning agent for diseases for which hematopoietic cell transplants (HCT) of allogeneic or gene-modified cells are the only known curative therapy. These diseases include (but are not limited to) acute myeloid leukemia, myelodysplastic syndrome, rare genetic blood diseases such as primary immune deficiency diseases and hemoglobinopathies such as sickle cell disease. Jasper is also developing a novel cell engineering platform focused on transitently modifying hematopoietic stem cells to significantly improve the efficacy and safety of donor allogeneic transplant and gene therapies. By creating novel, safe and highly effective conditioning regimens for hematopoietic transplantation, Jasper is leading the field with innovative clinical trials to safely bring cures to patients suffering from a variety of life-threatening diseases.

The Jasper vision is to build a leading biotechnology company to advance the field of hematopoietic cell transplantation (HCT) by leveraging its basic and translational science to generate a pipeline of innovative therapeutics in the areas of HCT conditioning, immune modulation, cell engineering and gene editing therapies.

Job Description

The Director, Clinical Operations will have responsibility for all day-to day trial management and vendor management for one or more clinical studies in the Jasper portfolio. This position will report directly to the Vice President of Clinical Operations. The Director, Clinical Operations will also collaborate with the VP of Clinical Operations and other key functions both internally and externally to ensure successful completion of all clinical activities/study deliverables within the required time frame and budget.

Job Description:

  • Responsible for the operational strategy and execution for one or more clinical programs
  • Collaborate with the VP of Clinical Operations and other key functions both internally and externally to ensure successful completion of all clinical activities/study deliverables within the required time frame and budget.
  • Lead identification and selection of potential clinical vendors.
  • Actively collaborate in design and implementation of clinical protocols, clinical data collection, and quality management
  • Serve as issue escalation point for vendors on assigned clinical programs.
  • Accountable for the work product for the study(ies).
  • Manage direct reports including performance management and professional development planning for team members
  • Lead the planning and implementation of clinical studies including scenario planning, forecasting enrollment and timelines, estimation of resources and budget, and development of operational strategies.
  • Contribute to developing department processes to ensure adherence to Jasper standards, and all applicable regulations and guidelines.
  • Contribute to the development and maintenance of the necessary resource and budget forecasting for Clinical Operations.
  • Lead the development of standard clinical trial management plans and tools.
  • Contribute and facilitate Clinical Operations' GCP compliance activities, reporting, and inspection readiness systems and activities.
  • Oversee clinical site and sponsor GCP inspection preparation and support activities.
  • Oversee study budget(s) and review/approve invoices.
  • All work must adhere to ICH Good Clinical Practice (GCP) guidelines and comply with company SOPs.
  • Participate as an integral member of the development team to provide clinical operational input in overall product development planning

Qualifications

  • Bachelor’s degree required or RN/PA with professional clinical experience; Master’s degree or PhD in health-related science or equivalent preferred.
  • 8-10+ years of experience managing Phase 1-4 clinical trials.
  • Have experience managing direct reports.
  • Excellent organizational skills and attention to detail.
  • Expertise in executing on commitments in a fast-paced, dynamic environment where ambiguity is present.
  • Strong understanding of quality requirements from clinical related activities to support regulatory filing.
  • Ability to efficiently perform multiple tasks and manage changing priorities.

Additional Information

Other Knowledge and Skills;

  • Ability to build strong relationships with co-workers of various backgrounds and expertise.
  • Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor.
  • Exhibit an entrepreneurial spirit with “can-do” approach.
  • Assist and manage the review of Clinical Development operating procedures and oversee changes to processes and/or implementation of new processes.
  • Ability to effectively communicate and exhibit exceptional interpersonal skills; strong team player.
  • Excitement about the vision and mission of Jasper.

 

What We Offer;

  • ·A growing company focused on advanced, transformational scientific research aiming to cure multiple, life-threatening and devastating diseases
  • ·Collaborative company culture headed by an experienced, top-tier management team, invested in your long-term professional development
  • ·Well-funded enterprise with multiple, successful rounds of fund-raising.
  • ·Validating collaborations among leading research centers and innovative gene therapy partnerships
  • ·Competitive compensation and benefits
  • ·Jasper Therapeutics is an equal opportunity employer

information will be kept confidential according to EEO guidelines.