Director, Clinical Development, Medical Monitoring Lead at Abata Therapeutics

Boston, 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, PharmaceuticalsIndustries

Requirements

Versatile, self-motivated team player who thrives in a fast-paced collaborative environment
Ability to manage multiple projects concurrently
Excels at building relationships and trust with key stakeholders, particularly across nonclinical and clinical functions, as well as externally
Knows when to step in and lead and when to offer support

Responsibilities

Lead medical monitoring/reporting and safety activities in partnership with clinical sites and CROs
Act as the medical contact at the company for clinical/medical issues for ongoing studies
Interpret and report on results of clinical studies, in partnership with other internal study stakeholders for all phases of development
Participate or lead in safety review meetings and provide clinical input into adverse event evaluation and reporting
Support or when needed, lead, clinical program design activities, including planning, execution, and completion of clinical trials according to all applicable regulations and guidance, ICH/GCP, and Entrada SOPs
Partner with Clinical Operations to ensure all clinical study activities are completed in accordance with applicable regulations and guidance; ICH/GCP, and Entrada SOPs
Develop and maintain relationships with key opinion leaders and Principal Investigators
Provide management personnel with timely updates on progress and changes in scope, schedule, and resources as required
Ensure compliance with all applicable regulatory standards related to global clinical trials and interactions with physicians
Develop and maintain professional relationships with academic and community-based study sites involved in clinical development programs
Support clinical content of all clinical and regulatory documents, including protocols, INDs, CTAs, investigator brochures, CRF’s, annual IND reports, CSR’s, ISS’s, ISE’s, and clinical expert reports
Support relevant clinical advisory boards, data monitoring committees and medical/scientific meetings, including collaboration in preparation

Skills

Clinical Development

Medical Monitoring

Rare Diseases

Cross-Functional Collaboration

Stakeholder Management

Therapeutic Development

Biopharmaceuticals

Oligonucleotide Programs

Drug Delivery

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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