Director, Non-Clinical Program Management 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, Neurology, PsychiatryIndustries

Requirements

Bachelor’s or advanced degree in life sciences (neuroscience, pharmacology, toxicology, or related discipline)
10+ years of experience in biotech/pharmaceutical industry, including at least 3 years in non-clinical or preclinical project management
Familiarity with drug discovery and IND-enabling workflows
Experience working with CROs and managing outsourced studies preferred
Understanding of regulatory expectations for non-clinical development (FDA, EMA, ICH)
Strong organizational, analytical, and problem-solving abilities
Excellent written and verbal communication skills
Proficiency in project management tools (e.g., Smartsheet, MS Project, or equivalent)
Ability to thrive in a fast-paced, cross-functional biotech environment
Background in neurology, neuroscience, or CNS drug development preferred
PMP or equivalent project management certification a plus

Responsibilities

Manage Program team meetings, including leading discussions to drive to effective decision-making, agenda creation, and meeting minutes
Establish project milestones, manage work plans, and ensure resources are aligned to meet project objectives
Identify and track critical path/activities, risks, contingencies, and alternatives
Collaborate with and support all stakeholders to ensure integration of project and functional goals
Develop program budgets and oversee program budget forecasting and reporting
Identify and mitigate project risks, ensuring proactive communication and resolution of issues
Coordinate cross-functional input from discovery, pharmacology, toxicology, DMPK, and CMC teams
Support design, initiation, and monitoring of non-clinical studies, including pharmacology and toxicology
Facilitate interactions between internal scientific teams and external CROs, ensuring clear communication of objectives and deliverables
Manage documentation, data flow, and reporting for regulatory submissions (e.g., IND, CTA)
Lead regular project team meetings, prepare agendas, capture minutes, and follow up on action items
Summarize project status and key milestones for senior management and program governance reviews
Maintain alignment between scientific teams and program management on priorities and timelines
Contribute to development and optimization of processes and tools to improve efficiency in non-clinical project execution

Skills

Program Management

Cross-Functional Team Leadership

IND-Enabling Studies

Preclinical Studies

Risk Management

Project Milestones

Budget Forecasting

CRO Management

Pharmacology

Toxicology

DMPK

CMC

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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