[Remote] Director, Clinical Development Scientist at Abata Therapeutics

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Not SpecifiedCompensation

N/AExperience Level

N/AJob Type

Not SpecifiedVisa

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Requirements

Master's degree in a life science, pharmacy, or a related field
Minimum 5 years of experience in clinical development, preferably in rare diseases or neurology
Proven experience in leading clinical sections of trial and program-level regulatory documents
Strong business communication skills, with the ability to write and present complex documents internally and externally
Experience in literature review, KOL interactions, and attending scientific meetings
Ability to work with cross-functional teams, study vendors, and clinical trial sites
Strong regulatory knowledge, including GCP and regulatory requirements
Proactiveness in identifying challenges and risks, and implementing appropriate actions with some supervision
Motivation to work in a fast-paced, dynamic environment and to contribute to the development of transformative medicines
Ability to work remotely and collaborate with clinical operations and external partners

Responsibilities

Provide clinical leadership and strategic medical input for all clinical deliverables in the assigned project or section of a clinical program
Lead development of clinical sections of trial and program-level regulatory documents
Drive execution of the program and/or clinical trial in partnership
Support the Clinical Development program lead by providing medical input into Clinical Development Plan (CDP) and Clinical Trial Protocol (CTP) reviews
Contribute to the development of disease clinical standards for new disease areas
Lead protocol development for new selected indications, working closely with relevant external and internal stakeholders
Support interactions with external and internal partners, including KOLs and decision boards
Medical monitoring of assigned clinical trials, data and safety review, and working closely with clinical operations and external partners
Collaborate with internal and external stakeholders to ensure timely recruitment
Present clinical development plans to relevant internal stakeholders to shape the new indication selection process

Skills

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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