Director, Clinical Science (Autoimmune)

San Diego, California, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, TherapeuticsIndustries

Requirements

Candidates must possess an advanced degree in Life Sciences and a minimum of 8 years of industry experience, with at least 5 years dedicated to clinical trials as a Clinical Scientist. A strong understanding of autoimmune drug development, clinical trial processes, study design, statistics, and clinical operations in a biotech or pharmaceutical setting is required. Proficiency in data review and trend analysis, knowledge of data monitoring committees and GCP/regulatory requirements, critical evaluation skills, leadership abilities, and strong project management skills are essential.

Responsibilities

The Director, Clinical Science will support the strategic planning and execution of clinical-stage programs, contributing clinical science input to development strategies and collaborating with Clinical Operations on trial design and execution. Responsibilities include assisting in the development of clinical trial documents, overseeing data review plans and strategies, performing clinical data review to identify trends and ensure subject safety, and supporting regulatory activities such as authoring/reviewing clinical portions of regulatory documents and preparing for meetings with regulatory agencies. The role also involves developing presentation materials and maintaining scientific knowledge in relevant therapeutic areas.

Skills

Clinical Development

Clinical Trial Design

Clinical Operations

Protocol Development

Data Review

Regulatory Documents

Immunotherapy

ARM Platform

Adaptive Immune Response Modulator

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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