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.

POSITION SUMMARY

The Clinical Trial/Sr. Clinical Trial Manager manages the overall operation of the clinical study including project planning, budget, resource management, contract research organization, and vendor management. Manages clinical operational plan and incorporates the study and scientific plan. May develop study related documents and overall direction for the clinical sites to establish protocol adherence. Ensures compliance with good clinical practices, good manufacturing practices and regulatory guidelines. Recommends and implements innovative process ideas to impact clinical trial management. May develop and manage clinical budget and develop contingency plans for clinical trials. Oversees clinical trials staff and manages all aspects of clinical operational plan.

Responsible for managing full scope of study. Acts as a cross functional liaison to ensure study plan aligns with business development strategies.

RESPONSIBILITIES

• Lead both an internal and external/CRO study management team, to ensure the

successful conduct of clinical trials in accordance with state and federal regulations,

GCP regulations, ICH guidelines, and internal SOPs

• Manage the supervision of contracted clinical research organizations, clinical

laboratory vendors, and other outsourced work

• Author and/or review as needed clinical study documents (protocols, informed consent

forms, clinical study plans, case Report Forms, etc.).

• Drive IRB/ethics committee and regulatory submissions as needed to support study

timelines

• Effectively evaluate qualified study sites, perform site initiation, plan and present at

investigator meetings/advisory boards, and implement study start up activities

including development of documents related to conduct of the study in collaboration

with the clinical study team

• Manage and review study budgets and investigator grants

• Support the set up and management of the Trial Master File (TMF)

• Assess study drug requirements and shipment logistics; contribute to labeling strategy

• Provide periodic review of clinical data, quality metrics and study deviations

• Review clinical monitoring reports to ensure timely completion and identification of

issues

• Ensure trial samples are ready to be sent to vendors in order to meet trial deliverables

• Responsible for timelines (from initiation to closure) ensuring they are met

• Communicate study-status and issues to ensure timely decision-making by senior

management

• Complete and maintain internal clinical trial metrics, dashboards, and other internal

updates. Proactively identifies project risks and resolves with minimal oversight.

QUALIFICATIONS AND EXPERIENCE

• Bachelor’s degree in a scientific discipline is required. Advanced degree preferred.

• At least 5 years of clinical trial experience in a pharmaceutical, biotech, hospital setting,

or a CRO is required

• Demonstrated working knowledge of GCP, ICH guidelines and FDA regulations

• Excellent time management skills with the ability to prioritize deadlines

• Excellent verbal and written communication skills

• Strong organizational skills, attention to detail and the ability to handle multiple

tasks/projects

• Self-starter with a demonstrated ability to work in collaboration and cooperation with

members of a multidisciplinary team

• Travel may be required (up to 30%).

OTHER KNOWLEDGE AND SKILLS

•Comprehensive understanding of the overall drug development process

•Team player with ability to motivate cross-functional team members

•Excellent ability to prioritize, drive projects forward and resolve conflicts

•Willing to be accountable for team performance

•Solid understanding of either the oncology, rare disease, and/or autoimmune therapeutic

areas.

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 and information will be kept confidential according to EEO guidelines.

• Seniority Level

  Director

• Industry

  • Biotechnology
  • Pharmaceuticals

• Employment Type

  Full-time

• Job Functions

  • Research
  • Project Management