Clinical Trial Manager
Abata has a big vision focused on translating the biology of regulatory T cells (Tregs) into transformational medicines for patients, particularly in severe autoimmune and inflammatory diseases with inadequate or no therapeutic options. While cell therapies represent a significant advancement in treating human disease, they have not yet been rigorously evaluated and developed for the treatment of autoimmune and inflammatory diseases. The company believes that by engineering Tregs for targeted activation only at the site of disease, enabling a robust, durable response, while avoiding systemic immune suppression, they can revolutionize the treatment of these challenging chronic diseases.
Our work is transformative which is why we hire the best, brightest, and most importantly…kind people. Being kind is not just a personality trait we look for, it’s a core value, embedded in the way we work and how we shape your experience at Abata Therapeutics. One of the most important aspects of your experience at Abata is how you develop and grow with the company. Our culture of learning and growth enables everyone to do their best work and contribute to fulfilling our mission.
Abata is looking for a talented Clinical Trial Manager to oversee our clinical studies. This position will be in the exciting position of moving innovative, transformative therapies into the hands of patients. Some of the key components of this role include the development and implementation of operational plans, the management of clinical vendors, the management of investigational site relationships, and internal cross functional team coordination to keep these innovative plans moving forward. This candidate should be able to lead complex early phase cell therapy clinical studies.
- Accountability for oversight of day-to-day operations of study execution from startup through closeout including but not limited to study document creation and implementation, enrollment, monitoring, data cleaning, clinical site/KOL interactions, and CRO/vendor management.
- Collaborate with a dynamic Abata cross-functional team to deliver clinical studies that are on time and within budget guidelines, while ensuring quality in accordance with the protocol and ICH GCP guidelines.
- Coordinate with technical operations, vendors, and sites to facilitate patient apheresis collection scheduling and supply chain logistics. Work with both internal teams and external vendors to oversee logistics in relation to the collection and shipment of biological specimens and starting material for drug product manufacturing.
- Ensure reliable quality data are delivered by reviewing monitoring reports, protocol deviations, clinical data listings and attending or overseeing site monitoring visits. Collaborate with cross functional leads to ensure appropriate data reviews are conducted during clinical trials.
- Support the Clinical Development Operations and the greater Clinical Development organization though identifying and implementing process improvements and efficiencies across programs, and assisting with the onboarding and mentoring of new or junior clinical operations associates, as necessary.
Requirements and Qualifications:
- Demonstrated ability to achieve with high competency the key responsibilities of the job description above. Bachelor's Degree is required, preferably in a scientific/clinical discipline.
- Ability and interest in tactical implementation as well as higher level strategic responsibilities.
- Experience with a biotechnology/pharmaceutical company is required, small biotech experience preferred. Experience with a CRO may be considered part of the clinical operations experience.
- Early phase clinical trial experience required. Cell therapy (including overseeing vein to vein and related supply chain processes) experience is preferred.
- Strong project management and multi-functional team leadership skills, including interpersonal communication (including ability to effectively interface with senior leaders within and external to the company), verbal and written communication, organizational aptitude, and attention to detail.
- Travel 10-20% including visits to investigational sites
We are an equal opportunity employer offering a competitive salary and benefits package. All applicants should be legally entitled to work for any employer in the US.
Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.
This is an on-site position based in the Watertown, MA office and the employee will be required to work in the office on a regular basis.
Abata Therapeutics will require compliance with our COVID- 19 vaccination policy. Please Review our conditions of employment.
Conditions of employment:
All current Abata employees have received the first two rounds of vaccinations against COVID-19. Vaccination status must be confirmed prior to any new hires joining the team. Up to date vaccination is strongly encouraged for every employee who intends to work onsite at our office and lab facility. Should an employee choose not to receive the vaccine, we will seek to understand the facts of their individual circumstance and determine if an appropriate work arrangement can be achieved.