Senior Director, Clinical Development 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, NeuroscienceIndustries

Requirements

MD or equivalent
Preferred: Board Certified/Board Eligible in neurology or psychiatry
Minimum 3 years of CNS research
Preferred: Minimum 5 years industry experience, including demonstrable success at leading and implementing clinical development strategy and clinical studies
Preferred: Minimum 3 years in research in neurodegenerative diseases, particularly Alzheimer’s disease
Preferred: Meaningful regulatory interactions, including NDA and IND experience
Established relationships with thought leaders and investigators in neurodegenerative diseases
Demonstrated ability to work well within a geographically diverse team structure
Demonstrated ability to lead and manage cross-functional teams
Able to work within a growing organization within the U.S

Responsibilities

Provide overall leadership and management of a cross-functional development team, accountable for the development of a promising compound for the treatment of Alzheimer’s dementia
Support the Senior Vice President, Clinical Development, on issues critical to optimizing the quality, efficiency, engagement, accountability, and responsiveness of the department, including areas of strategic planning and execution, organizational structure, innovation, communication and governance
Ensure study adherence to Clinical Practice
Continually evaluate study data and study metrics, including eligibility criteria
Partner with pharmacovigilance to review and report clinical safety data for presentation to key internal and external stakeholders, including management and Data Safety Boards
Interact with sites and CROs to support study awareness, patient recruitment, and quality of study conduct
Contribute to the preparation and review of regulatory documents, IND annual reports, IND safety reports, Investigator Brochures and development plans
Maintain and build productive relationships with investigators, thought leaders and centers of excellence across the scientific community, as well as with colleagues across the MapLight organization
Communicate appropriate program issues and results to key internal and external stakeholders
Provide clear and insightful clinical and scientific expertise to advance the successful transition of compounds from discovery to full development, and subsequently to life cycle management
Review business development opportunities, translating business needs to cost-effective development strategies that provide a competitive advantage and meet regulatory requirements
Comply with current local and international regulations, laws, scientific and regulatory guidance’s, Good Clinical Practices, and MapLight’s policies and procedures

Skills

Clinical Development

Drug Development

Neurologic Diseases

Dementia

Cross-Functional Leadership

Pharmacovigilance

Regulatory Documents

IND Preparation

CRO Management

Patient Recruitment

Strategic Planning

Data Safety Monitoring

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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