Abata Therapeutics

Associate Director, Clinical Operations

San Diego, California, United States

$120,000 – $160,000Compensation
Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level
InternshipJob Type
UnknownVisa
Pharmaceuticals, Clinical Research, OncologyIndustries

Requirements

Candidates should possess a Bachelor's degree in a related scientific or healthcare field, and a combination of relevant experience is preferred. They must have a strong understanding of clinical trial processes, regulatory compliance (GCP, FDA, ICH), and the ability to lead cross-functional teams. Strong communication and interpersonal skills are also required.

Responsibilities

The Associate Director, Clinical Operations will independently manage all operational aspects of assigned clinical trials, with a focus on early-phase oncology studies, including overseeing CROs, vendors, and clinical sites across both U.S. and international regions. This role involves leading the planning and execution of complex Phase I oncology trials, ensuring compliance with regulations, managing external partners, conducting site visits, developing study documents, reviewing monitoring reports, providing guidance to team members, and collaborating with internal stakeholders to ensure smooth clinical program execution. They will also prepare study updates, represent Clinical Operations in meetings, and contribute to continuous process improvement, while being willing to travel up to 15% for site visits and conferences.

Skills

Clinical Trial Processes
Regulatory Compliance (GCP, FDA, ICH)
CRO Management
Vendor Management
Clinical Site Management
Phase I Trials
Study Document Development
Monitoring Reports
Site Visits
Travel
Communication Skills
Interpersonal Skills
Team Leadership

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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