Director, Clinical Operations at Abata Therapeutics

San Diego, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, OncologyIndustries

Requirements

Bachelor’s degree in life sciences or related field
Minimum of 10–14 years of total experience in clinical research, including at least 6-8 years in clinical trial management
Demonstrated experience managing IND-enabling or early-phase oncology trials, particularly in solid tumors, immunotherapy, and/or biologics
Proven track record of leading trials from start-up through close-out

Responsibilities

Own the operational strategy and execution for early phase oncology program, ensuring all clinical activities support IND-enabling objectives and future clinical development plans
Lead cross-functional teams (Clinical Development, Regulatory Affairs, Medical Affairs, CMC) to ensure program milestones are met with budget and risks are proactively managed
Represent Clinical Operations in program-level meetings, regulatory interactions, and external collaborations
Lead the planning, initiation, execution, and close-out of complex Phase I oncology trials
Ensure all trial activities are conducted in accordance with the protocol, SOPs, GCP, and applicable regulations
Oversee the development and review of essential study documents (protocols, informed consent forms, CRFs, monitoring plans, study manuals) tailored to IND-enabling requirements
Manage and oversee external partners including CROs, central labs, safety vendors, eTMF providers, and others
Participate in site selection, feasibility assessments, and initiation visits
Build strong relationships with vendors, investigators, and site staff to support efficient enrollment and high-quality data collection
Prepare and deliver study updates, metrics, and presentations to senior leadership
Establish and grow the Clinical Operations team over time, fostering a culture of high performance and continuous improvement
Manage, mentor, and support direct reports, fostering professional development and team performance
Review monitoring reports and ensure timely resolution of issues
Collaborate with finance and legal teams to manage study budgets, review vendor invoices, and negotiate contracts and change orders
Contribute to the development and implementation of SOPs, work instructions, and operational plans to enhance team efficiency and compliance
Perform periodic oversight visits of sites and/or vendors to assess progress and compliance
Other activities as assigned

Skills

Clinical Trial Management

Regulatory Compliance

GCP

FDA

ICH

CRO Management

Vendor Management

Cross-functional Team Leadership

Protocol Development

Informed Consent Forms

CRFs

Monitoring Plans

Study Manuals

Budget Management

Risk Management

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.

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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