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

Position Overview

  • Location Type: Not specified
  • Employment Type: Not specified
  • Salary: Not specified

The Executive Director, Clinical Operations Process & Strategic Planning role at Apogee Therapeutics is a newly created position focused on ensuring the Clinical Operations organization is prepared to execute multiple global late-phase studies. This role involves assessing, planning, and implementing global processes, strategies, and solutions, analyzing current processes and systems, and providing strategic guidance on Process Excellence and Clinical Compliance. It reports into the Clinical Trial Excellence organization and will be a key leader on the Clinical Operations Leadership Team (COLT).

Requirements

  • Not specified

Responsibilities

  • Strategically lead all efforts related to ensuring clinical operations is set up from a people, process, vendor, and technology perspective to effectively execute on multiple global Phase 3 studies.
  • Conduct gap analyses; identify potential risks to clinical operations related to trial readiness; and operationalize mitigation strategies in collaboration with key stakeholders/leadership.
  • Strategically evaluate and implement solutions to address any operational geographic gaps related to ensuring clinical operations delivery teams are set up for optimal study execution.
  • Optimize [Not specified]

Company Information

Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed biotechnology company founded in 2022. They are focused on developing differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease, and other inflammatory and immunology indications with high unmet need. Apogee’s antibody programs aim to overcome limitations of existing therapies by targeting established mechanisms and incorporating advanced antibody engineering. The company is committed to building an exceptional company culture based on its C.O.R.E. values: Caring, Original, Resilient, and Egoless.

Application Instructions

  • Not specified

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.

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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