[Remote] Clinical Scientist, Clinical Development at Abata Therapeutics

Remote

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, DermatologyIndustries

Requirements

Advanced degree in life sciences, such as a PhD, PharmD or related field
Understanding of clinical trial methodologies and regulatory requirements
Experience in clinical study design, data analysis, data review and interpretation
Good written and verbal communication skills
Ability to work effectively in a collaborative, cross-functional environment

Responsibilities

Contributes to the development of clinical trial protocols, including patient selection criteria, study endpoints, and data collection methods
Monitors the data of clinical trials at study sites, ensuring adherence to protocols and good clinical practice (GCP) guidelines
Performs data review, reconciliation and standardization to ensure high quality outputs
Reviews clinical data to support in the assessment of the safety and efficacy of the investigational drug
Supports the development of clinical documents required during the clinical development process (including but not limited to: Clinical Study Protocols, Investigator Brochures, Clinical Study Reports)
Maintains knowledge of the therapeutic area, disease state, and potential drug effects
Assesses clinical data to help identify and analyze safety concerns and adverse events
Stays current with relevant medical literature and clinical trial methodologies
Conducts literature reviews as needed for focused scientific questions or documentation
Works closely with other functions including clinical operations, regulatory affairs, medical affairs, biometrics, pre-clinical and project management teams to ensure data integrity during the clinical development process

Skills

Key technologies and capabilities for this role

Clinical TrialsProtocol DevelopmentData ReviewStudy ImplementationPatient SelectionClinical Data ManagementCross-Functional Collaboration

Questions & Answers

Common questions about this position

What is the work location and arrangement for this role?

The position is hybrid in Waltham, MA, requiring candidates to be in-office 3 days per week, with remote work considered.

What are the key responsibilities of the Clinical Scientist?

The role involves contributing to clinical trial protocols, monitoring data at study sites, performing data review and reconciliation, reviewing clinical data for safety and efficacy, and supporting clinical documents like protocols and study reports.

What kind of company culture does Oruka Therapeutics foster?

Oruka seeks top talent passionate about making a difference and eager to contribute to an engaged, inclusive, and positive company culture.

What salary or compensation is offered for this position?

This information is not specified in the job description.

What makes a strong candidate for this Clinical Scientist role?

Strong candidates are top talent passionate about making a difference, with expertise in clinical trial design, data review, GCP guidelines, therapeutic areas like dermatologic diseases, and cross-functional collaboration.

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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