Job Description

Senior Medical Director, Pharmacovigilance and Safety

Join to apply for the Senior Medical Director, Pharmacovigilance and Safety role at Oruka Therapeutics .

**About Us:**
Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics to set new standards for treating chronic skin diseases. Our mission is to help patients achieve high rates of disease clearance with infrequent dosing. We are advancing a portfolio of potentially best-in-class antibodies targeting mechanisms underlying psoriasis and other inflammatory diseases. Since February 2024, we have raised nearly $500M from top-tier investors, with our first program expected in the clinic in Q1 2025. Visit for more information.

We are seeking talented individuals passionate about making a difference and contributing to an inclusive, positive company culture.

Job Title:

Senior Medical Director, Pharmacovigilance and Safety

Location:

Remote or Hybrid (near Waltham, MA or Menlo Park, CA), with in-office requirement of 3 days/week.

Role Overview:

The Senior Medical Director oversees drug safety and pharmacovigilance activities, ensuring high-quality data to support pipeline safety and efficacy. Responsibilities include managing safety activities, overseeing vendors, assessing safety profiles, and collaborating with stakeholders to ensure compliance and safety documentation.

Key Responsibilities:

• Lead safety surveillance and risk management, including review of ICSRs and safety data.
• Provide medical safety input for clinical trial design and safety data analysis.
• Develop safety surveillance strategies, identify safety issues, and recommend mitigation.
• Maintain relationships with stakeholders, contribute to safety regulatory documents, and ensure compliance.

Medical Expertise:

• Develop response strategies, contribute to regulatory submissions, and ensure safety components of reports.
• Provide leadership for IDMC and Adjudication Committees.

Minimum Qualifications:

• MD/DO or equivalent with completed residency.
• At least 6 years of safety experience in pharma.
• Expertise in global pharmacovigilance regulations.
• Strong communication, leadership, and analytical skills.

Compensation:

Base salary and equity, with a performance bonus. Salary range: $265,000$295,000, depending on experience and location. Remote candidates may travel up to 20%.

What We Offer:

• Impactful work in a vibrant company culture.
• Competitive salary and benefits.
• Opportunities for growth and development.

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