Manager, Clinical Contracts at Abata Therapeutics

San Diego, California, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, Clinical TrialsIndustries

Requirements

Bachelor’s degree required
5+ years’ experience in a contract management position within a biotechnology, pharmaceutical, academia or Clinical Research Organization (CRO)
Clinical Site Budget experience necessary
Experience within Global Oncology Phase 1-3 clinical trials preferred
Grant Plan experience a plus
Good knowledge of ICH-GCP, pharmaceutical related regulations and laws
Ability to thrive in a fast-paced growing company with minimal direction and ability to adjust to changing priorities
Proficiency in Microsoft Excel at an Intermediate level required
Strong analytical and contract administration skills
Strong verbal and written communication skills

Responsibilities

Provide comprehensive contract lifecycle management: Work closely with Clinical Operations, Legal, Finance, and other internal and external stakeholders to support the timely initiation, contractual term review, negotiation, risk assessment, execution and administration of contracts
Manage tracking of contracts, amendments and budgets, and provide updates to the project and cross-functional teams
Serve as point person for contracts with internal and external stakeholders
Support RFx and Vendor Management activities
Support internal oversight of site payment management
Establish contracting SOPs and guidance documents
Active participation in team meetings for the purpose of expediting contracts to execution
Build and maintain strong relationships with clinical sites and vendors
Facilitate contract actions and processes independently and effectively in a dynamic environment with competing priorities
Respond promptly and professionally to inquiries from internal team members and external vendors
Identify and implement process improvements to enhance efficiency and accountability
Ensure compliance with SOPs and regulatory guidelines, addressing QA and audit requests as needed

Skills

Contract Negotiation

Contract Lifecycle Management

Vendor Management

Budget Tracking

Risk Assessment

SOP Development

Cross-Functional Communication

Analytical Skills

Process Improvement

Regulatory Compliance

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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