[Remote] Manager/Senior Manager, Clinical Outsourcing at Abata Therapeutics

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Not SpecifiedCompensation

N/AExperience Level

N/AJob Type

Not SpecifiedVisa

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Requirements

BA/BS in related discipline, or equivalent experience
4-6 years of related experience in a Biotech or Pharmaceutical organization

Responsibilities

Assist in the development of structure and processes supporting the Clinical Outsourcing function
Drive the creation of complex RFI and RFP document templates
Lead and contribute to complex outsourcing initiatives and process improvement
Create effective partnerships with vendors to cultivate long-term relationships
Negotiate Clinical Trial Agreements and site budgets with US and Canadian sites
Participate in vendor governance activities
Partner with vendors and internal stakeholders to manage and resolve vendor performance issues
Manage corporate risk by working with legal to develop contracts
Effectively communicate and cultivate internal and external vendor relationships
Negotiate final scopes of work, budget, and payment schedules with cross-functional stakeholders
Negotiate change orders and ensure vendor adherence to contract terms
Generate RFIs, RFPs, and assist with service provider selection process
Oversee and execute contract lifecycle management
Drive the identification, development, improvement, and implementation of outsourcing processes and tools
Be a key contributing member of the Clinical Outsourcing team

Skills

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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