[Remote] Medical Director, Drug Safety and Pharmacovigilance at Abata Therapeutics

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Not SpecifiedCompensation

N/AExperience Level

N/AJob Type

Not SpecifiedVisa

N/AIndustries

Requirements

MD, DO, or U.S. equivalent
At least 3 years of industry pharmacovigilance (PV) experience as a safety physician
Experience in neurology, immunology, and rare disease (preferred)

Responsibilities

Serve as the safety physician lead for designated Dianthus’s product
Conduct medical review of individual case safety reports (ICSRs), including seriousness, expectedness, and causality assessment
Perform aggregate data analysis and interpretation
Author and provide medical input to safety related regulatory documents
Contribute to / lead safety review committee activities
Contribute to relevant clinical and regulatory documents
Collaborate with relevant functions on safety issues
Review and summarize relevant scientific and clinical literature
Support senior medical director on complex pharmacovigilance tasks
Support internal and external pharmacovigilance audits and regulatory inspections
Collaborate with pharmacovigilance scientist and operation on case processing, database oversight, and compliance monitoring
Stay current with global pharmacovigilance regulations, guidelines, and best practices

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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