Senior Medical Director, Pharmacovigilance and Safety

Position Overview

• Location Type: Remote or Hybrid (3 days/week in-office if located near Waltham, MA or Menlo Park, CA)
• Employment Type: Full-time
• Salary: Not specified

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. As we build our core team, we're seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger. Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture.

Job Title: Senior Medical Director, Pharmacovigilance and Safety

Requirements

• Not specified

Responsibilities

• Safety Leadership and Risk Management:
  • Responsible for safety surveillance and risk management activities including but not limited to: medical review of Individual Case Safety Reports (ICSRs), routine review of safety data, and ongoing review of assessments for safety signals or in response to Regulatory Authority requests.
  • Provides medical safety input into the design and conduct of clinical trials.
  • Plans and interprets safety data analyses, prepare and present safety data summaries to internal and external stakeholders.
  • Acquire and contribute knowledge of relevant drug class and/or competitor safety issues.
  • Lead the development of safety surveillance strategy, identify potential clinical risks.
• Collaborates closely with internal and external stakeholders to ensure compliance with regulations and guidelines.
• Contributes to safety regulatory documents.
• Protects participant safety.

Company Information

• Company Name: Oruka Therapeutics
• Stock Ticker: ORKA
• Focus: Developing novel biologics for chronic skin diseases.
• Mission: To offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition.
• Funding: Raised nearly $500M since inception in February 2024.
• Clinical Pipeline: First program expected in the clinic in Q1 2025.
• Website: www.orukatx.com