Abata Therapeutics

Executive Director, Clinical Operations Process & Strategic Planning

Remote

Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Biotechnology, Pharmaceuticals, HealthcareIndustries

Requirements

Candidates should possess a Bachelor’s degree in a relevant field, such as Business Administration, Healthcare Management, or a related discipline, and have a minimum of 10 years of experience in clinical operations, process improvement, and strategic planning, preferably within the biotechnology or pharmaceutical industry. Strong analytical and problem-solving skills are essential, along with demonstrated leadership abilities and experience in managing complex projects and cross-functional teams.

Responsibilities

The Executive Director, Clinical Operations Process & Strategic Planning will lead efforts to ensure clinical operations is prepared to execute multiple global Phase 3 studies, conduct gap analyses, identify potential risks, and operationalize mitigation strategies in collaboration with stakeholders. They will strategically evaluate and implement solutions to address operational geographic gaps, optimize clinical operations delivery, and provide strategic guidance and oversight of the Process Excellence/Clinical compliance function. Additionally, this role will contribute to shaping the Clinical Operations strategy and ensuring the vision for excellence is effectively communicated and implemented as a key leader on the Clinical Operations Leadership Team.

Skills

Clinical Operations
Process Improvement
Strategic Planning
Global Trial Management
Risk Assessment
Vendor Management
Technology Implementation
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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