Abata Therapeutics

Director, Clinical Systems

Remote

Not SpecifiedCompensation
Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
BiotechnologyIndustries

Requirements

Candidates should possess a Bachelor’s degree in a relevant field, such as Computer Science, Information Systems, or a related discipline, and ideally have a Master’s degree. They should have a minimum of 8 years of experience in clinical systems, with a strong understanding of clinical trial operations, data management, and regulatory requirements. Experience with Risk Based Monitoring (RBM), Interactive Response Technology (IRT), Clinical Trial Management Systems (CTMS), Electronic Trial Master Files (eTMF), and Patient Reported Outcomes (ePRO/eCOA) is essential. Strong analytical and problem-solving skills are also required, along with the ability to effectively communicate technical information to both technical and non-technical audiences.

Responsibilities

The Director of Clinical Systems will lead clinical operations on system-related initiatives and throughout a clinical system’s life cycle, acting as the primary business change agent to ensure adoption of new capabilities and business processes. They will articulate global requirements, trial designs, and business processes to support the development of functional requirements for clinical systems, and develop business cases around clinical system needs and technologies. Additionally, this role involves partnering with CROs and internal stakeholders to manage and support the use of clinical systems, including developing and implementing clinical system processes, SOPs, work instructions, tools, templates, and training materials, and potentially managing direct reports who specialize in clinical systems.

Skills

Clinical Systems
Risk Based Monitoring (RBM)
Interactive Response Technology (IRT)
Clinical Trial Management System (CTMS)
Electronic Trial Master File (eTMF)
Patient Reported Outcomes (ePRO/ eCOA)
Business Process Development
SOPs
Work Instructions
Training
Cross-functional Collaboration

Abata Therapeutics

Develops therapies for autoimmune diseases

About Abata Therapeutics

Abata Therapeutics develops therapies for autoimmune diseases, focusing on type 1 diabetes. Their main product, ABA 201, is a Treg cell therapy aimed at patients with some remaining beta cell function. This therapy works by utilizing regulatory T cells to improve patient outcomes. Unlike many competitors, Abata targets a specific niche within the autoimmune disease market and collaborates with partners like ElevateBio for process development and manufacturing. The company's goal is to transform treatment options for autoimmune diseases through advanced research and development.

Key Metrics

Cambridge, MassachusettsHeadquarters
2021Year Founded
$184.8MTotal Funding
EARLY_VCCompany Stage
BiotechnologyIndustries
11-50Employees

Risks

Intensifying competition from companies like Sangamo Therapeutics may impact Abata's market share.
Stringent FDA scrutiny on manufacturing could delay Abata's clinical trials.
Rising clinical trial costs pose financial risks to Abata's pipeline progression.

Differentiation

Abata focuses on Treg cell therapies for autoimmune diseases like MS and diabetes.
Their lead product, ABA 201, targets type 1 diabetes with remaining beta cell function.
Abata's strategic partnership with ElevateBio enhances their manufacturing capabilities.

Upsides

Recent investment from Bristol Myers Squibb boosts Abata's Treg therapy pipeline development.
FDA's accelerated approval pathways may expedite Abata's clinical trials.
Growing autoimmune disease prevalence increases demand for Abata's innovative treatments.

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