Director, Clinical Pharmacology & Pharmacometrics at Abata Therapeutics

Burlington, Massachusetts, United States

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, Central Nervous System DisordersIndustries

Requirements

Ph.D. in Pharmaceutical Sciences or a related discipline
Formal training in Pharmacokinetics, Pharmacodynamics, and Drug Metabolism
Minimum of 6 years of experience in clinical drug development, preferably with small molecules
Demonstrated expertise in PK and PK/PD modeling, including recent applications using NONMEM
Strong scientific communication and presentation skills
Proven publication record in the field of clinical pharmacology and pharmacometrics

Responsibilities

As a core member of clinical program team, and as the clinical pharmacology and pharmacometrics lead, provide strategic input into the progression of drug candidates from pre-IND through NDA submission
Design and provide input into Phase 1–3 clinical study protocols, reports, and related clinical documentation
Perform, interpret, and communicate PK and PD analyses to support dose selection and clinical decision-making
Provide scientific rationale for dose selection and regimen optimization throughout clinical development
Author and contribute to regulatory submissions and represent the company in interactions with global health authorities

Skills

Clinical Pharmacology

Pharmacometrics

Pharmacokinetics

Pharmacodynamics

Quantitative Modeling

PK/PD Analysis

Dose Selection

Regulatory Submissions

Clinical Study Design

Cross-Functional Collaboration

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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