Director – Vice President, Clinical Development at Abata Therapeutics

Waltham, Massachusetts, United States

Apply Now

Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Biotechnology, Gene TherapyIndustries

Requirements

High degree of scientific acumen and robust clinical development experience in advancing gene therapies from laboratory to clinical trials
Experience designing and implementing clinical development plans in a small company environment
Ability to collaborate with internal cross-functional teams and external contract organizations
Capability to create, cultivate, and maintain relationships with clinical investigators, medical experts, and members of the medical, scientific, and patient communities
Enthusiasm for bringing transformative treatments to patients
Located at the Affinia Therapeutics site in Waltham, MA with 4 days per week (M-Th) onsite

Responsibilities

Design and execute the First-in-Human Phase 1b/Phase 2 clinical trial for AFTX-201, Affinia’s lead program in BAG3-associated Dilated Cardiomyopathy, with planned IND submission in Q4 2025 and first patient dose Q1 2026
Lead the preparation and rollout of clinical protocols and additional critical documents such as the investigator brochure, IND/CTA, integrated clinical and statistical summary reports, and journal articles
Partner with Regulatory and Clinical Operations to ensure all regulatory and clinical study activities are completed efficiently and on time in accordance with applicable regulations and guidance
Review clinical data from all phases of development and lead the generation of study reports, publications, and regulatory documents
Optimize trial readiness and execution for BAG3-associated Dilated Cardiomyopathy and future indications by proactively identifying and evaluating available tools and datasets, and by strategically fostering research to fill critical gaps including in natural history datasets, registries, clinical outcomes, biomarkers, pathways to rapid genetic diagnosis, observational study protocols, and standard of care guidelines
Engage early with patients, families, researchers, and clinicians to better understand disease burden, needs, meaningful endpoints, acceptable and feasible clinical development strategies, and opportunities to partner toward the shared goal of finding better treatments
Be the primary clinical interface to peers in other functions and the clinical lead on the program team
Maintain scientific awareness regarding advances in indications of interest and in the field of gene therapy; regulatory awareness regarding new guidance and rules; and industry awareness regarding trends and competition through literature, conferences, and stakeholder interactions
Serve as representative for Affinia at scientific, medical, patient, health authority, and public meetings, ensuring that communications are grounded in the latest research and aligned

Skills

Clinical Development

Gene Therapy

Phase 1

Phase 2

Clinical Trials

AAV Capsids

Drug Development

Cross-Functional Collaboration

CRO Management

KOL Relationships

Cardiovascular Diseases

Neurological Diseases

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.

Land your dream remote job 3x faster with AI

Try Jobo Free