Abata Therapeutics

Medical Director, Clinical Development

Remote

Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Biotechnology, Pharmaceuticals, Clinical ResearchIndustries

Position Overview

  • Location Type: Hybrid – Waltham, MA (In-office 3 days/week, Remote considered)
  • Job Type: Full-time
  • Salary: Not specified

Job Title: Medical Director, Clinical Development

Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. We have raised nearly $500M since inception in February 2024 from top-tier investors and our first program is expected to be in the clinic in the first quarter of 2025. For more information, visit www.orukatx.com.

Requirements

  • Not specified

Responsibilities

Clinical Trial Design and Oversight:

  • Supports the development of clinical trial protocols, including patient selection criteria, study endpoints, and data collection methods.
  • Oversees the conduct of clinical trials at study sites, ensuring adherence to protocols and good clinical practice (GCP) guidelines.
  • Reviews and interprets clinical data to assess the safety and efficacy of the investigational drug.
  • Authors and contributes to clinical and non-clinical documents required during the clinical development process (including but not limited to: Clinical Study Protocols, Investigator Brochures, Clinical Study Reports).

Medical Expertise:

  • Provides medical expertise of the therapeutic area, disease state, and potential drug effects.
  • Reviews clinical data to identify and analyze safety concerns and adverse events, and makes appropriate recommendations to the team.
  • Stays current with relevant scientific literature and regulatory guidelines.

Company Information

Oruka Therapeutics (Nasdaq: ORKA) is a biopharmaceutical company focused on developing novel biologics for chronic skin diseases. They have raised nearly $500M since inception and expect their first program to be in the clinic in Q1 2025. They are building a company culture focused on engagement, inclusion, and positivity.

Skills

Clinical Trial Design
Protocol Development
Data Analysis
Good Clinical Practice (GCP)
Safety Monitoring
Regulatory Documentation
Medical Expertise in Dermatology/Inflammatory 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.

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