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

Remote

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, Autoimmune DiseasesIndustries

Requirements

MD, DO, or U.S. equivalent required
At least 3 years of industry pharmacovigilance (PV) experience as a safety physician
Experience in neurology, immunology, and rare disease preferred
Strong foundation in clinical medicine and pharmacovigilance
Excellent analytical and communication skills
Passion for improving patients’ lives through rigorous safety science

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, ensuring appropriate coding and compliance with global regulations
Perform aggregate data analysis and interpretation
Author and provide medical input to safety related regulatory documents such as periodic safety reports (e.g., DSURs, ASRs, PSUR, PADERs, etc.) or other deliverables as appropriate
Contribute to / lead safety review committee activities, including individual and aggregate data analyses, signal detection and evaluation, interpretation of safety signals and trends, and documentation and communication of safety assessments
Contribute to relevant clinical and regulatory documents, such as study protocols, investigator brochures, statistical analysis plan, and clinical study reports
Collaborate with relevant functions such as clinical development, data management, regulatory affairs, biostatistics, and medical affairs on relevant safety issues
Review and summarize relevant scientific and clinical literature to support safety evaluations and regulatory submissions
Support the senior medical director / designee on complex pharmacovigilance tasks/activities such as integrated safety analyses, benefit–risk assessments, and development of risk management strategies
Support internal and external pharmacovigilance audits and regulatory inspections
Collaborate closely with the pharmacovigilance scientist and operation to ensure high-quality case processing, database oversight, compliance monitoring, and preparation of relevant safety deliverables
Stay current with global pharmacovigilance regulations, guidelines, and best practices
Additional tasks as needed

Skills

Key technologies and capabilities for this role

PharmacovigilanceDrug SafetySignal DetectionRisk ManagementRegulatory SubmissionsSafety AnalysisClinical Medicine

Questions & Answers

Common questions about this position

Is remote work allowed for this position?

Yes, the company is open to you working remotely.

What is the salary or compensation for the Medical Director role?

This information is not specified in the job description.

What key skills are required for this role?

A strong foundation in clinical medicine and pharmacovigilance, excellent analytical and communication skills are required.

What is the company culture like at Abata Therapeutics?

The company is building a culture of individuals who hold core principles at the center of operations to elevate patient care.

Who does this position report to?

The position reports to the Senior Medical Director, Drug Safety and Pharmacovigilance.

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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