Abata Therapeutics

Senior Medical Director, Pharmacovigilance and Safety

Remote

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, BiotechnologyIndustries

Requirements

Candidates should possess a Medical Degree (MD or DO) with board certification in Internal Medicine or a related specialty, and a minimum of 10 years of experience in clinical drug development, with at least 5 years specifically in pharmacovigilance and safety. Strong knowledge of global regulatory requirements for pharmacovigilance, including those of the FDA, EMA, and other international regulatory agencies is required, along with experience managing pharmacovigilance vendors and leading safety teams.

Responsibilities

The Senior Medical Director of Pharmacovigilance and Safety will oversee drug safety and pharmacovigilance activities in clinical studies, ensuring high-quality data generation to support the safety and efficacy of the pipeline products. They will manage medical safety activities and processes, oversee pharmacovigilance vendors, and continuously assess safety profiles and benefit-risk of investigational compounds, collaborating with internal and external stakeholders to ensure compliance and contribute to safety regulatory documents while protecting participant safety.

Skills

ICSRs

Safety signals

Clinical trials

Risk 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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