Abata Therapeutics

Associate Director, Monitoring Oversight Management

Remote

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, Clinical ResearchIndustries

Requirements

Candidates should possess a Bachelor's degree in a relevant scientific or business field, and demonstrate at least 7 years of experience in clinical monitoring, oversight, or related roles within the pharmaceutical or biotechnology industry. Strong leadership skills and the ability to manage and mentor a team are essential, along with a thorough understanding of GCP, SOPs, and regulatory requirements.

Responsibilities

The Associate Director, Monitoring Oversight Management will lead Oversight CRAs globally, ensuring study deliverables are met with efficiency and quality, while contributing to the development and implementation of risk-based monitoring strategies. This role will also involve hiring in-house Oversight CRAs, assisting with resourcing and capacity management projections, facilitating resolution of monitoring-related issues, and supporting the monitoring head with operational readiness across clinical studies and therapeutic areas.

Skills

Clinical Monitoring

CRAs Oversight

CRO Management

Risk-Based Monitoring

Team Leadership

Regulatory Compliance

GCP

SOPs

Study 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.

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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