Director, Pharmacovigilance at Abata Therapeutics

San Diego, California, United States

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Graduate-level degree in life sciences, RN, or equivalent health-related training; MD or PharmD preferred
8+ years of pharmacovigilance experience in the biotech or pharmaceutical industry, including proven leadership roles
Strong knowledge of global PV regulations (FDA, EMA, APAC, ICH, GVP)
Experience in signal management, safety data interpretation, and regulatory reporting
Oncology and autoimmune experience prioritized
MPH or pharmacoepidemiology training desirable
Demonstrated ability to lead cross-functional safety initiatives and influence decision-making
Excellent communication, analytical, and organizational skills
Proficiency in safety databases (e.g., Argus, ARISg) and MedDRA coding
Ability to travel domestically and internationally as needed

Responsibilities

Develop and execute pharmacovigilance strategies in alignment with Janux’s clinical and regulatory goals
Represent Janux in safety-related interactions with global health authorities (e.g., FDA, EMA, APAC)
Lead the development and implementation of safety management plans, risk management plans (RMPs), and signal detection strategies
Ensure safety is proactively integrated into clinical development and decision-making processes
Oversee the collection, evaluation, and reporting of adverse events (AEs) and serious adverse events (SAEs) from clinical trials
Manage external PV vendors and ensure timely, high-quality execution of contracted activities
Maintain a central repository and program plan for all PV activities and deliverables
Ensure readiness and execution of safety procedures in response to emerging safety concerns
Author and review PV-related documents including DSURs, SMPs, RMPs, RSIs, and safety sections of clinical protocols and study reports
Ensure compliance with global PV regulations (FDA, EMA, APAC, ICH, GVP) and internal SOPs
Monitor and ensure adherence to PV agreements and safety data exchange agreements (SDEAs) with partners
Support internal audits and regulatory inspections; conduct root cause analyses and implement CAPAs as needed
Serve as the safety representative in cross-functional teams, including clinical, regulatory, and medical affairs
Educate internal teams on evolving safety regulations and best practices
Lead or contribute to internal safety review meetings, DSMBs, and safety advisory committees
Other duties as deemed necessary

Skills

Key technologies and capabilities for this role

PharmacovigilanceRisk Management PlansSignal DetectionAdverse Event ReportingDSURsSMPsRSIsFDA RegulationsEMA RegulationsICH GuidelinesGVPSafety Data Exchange AgreementsRoot Cause AnalysisCAPARegulatory Inspections

Questions & Answers

Common questions about this position

What education and experience are required for the Director of Pharmacovigilance role?

A graduate-level degree in life sciences, RN, or equivalent health-related training is required, with MD or PharmD preferred. Candidates need 8+ years of pharmacovigilance experience in biotech or pharma, including proven leadership roles, strong knowledge of global PV regulations, and experience in signal management and regulatory reporting.

What is the salary or compensation for this position?

This information is not specified in the job description.

Is this a remote position, or is there a location requirement?

This information is not specified in the job description.

What key skills are needed for this role?

Key skills include demonstrated ability to lead cross-functional safety initiatives, excellent communication, analytical, and organizational skills, and proficiency in safety databases like Argus or ARISg. Oncology and autoimmune experience is prioritized.

What makes a strong candidate for this Director of Pharmacovigilance position?

Strong candidates will have 8+ years of PV experience with leadership roles, expertise in global regulations and safety data management, and experience in oncology or autoimmune areas. MPH or pharmacoepidemiology training is desirable, along with skills to lead cross-functional teams and interact with regulatory authorities.

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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