Senior Medical Director, Pharmacovigilance and Safety

The posting, as Oruka Therapeutics wrote it

About Us

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. 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

Location: Remote OR Hybrid 3 days/week if located near office in either Waltham, MA or Menlo Park, CA will be required.

Role Overview

Oruka is seeking an experienced, collaborative pharmacovigilance leader to provide medical and scientific safety oversight for Oruka’s investigational products. The Senior Medical Director, Pharmacovigilance and Safety will lead safety activities and processes, oversee Oruka’s pharmacovigilance vendors, and ensure continuous assessment of each product's safety profile and benefit-risk balance. This role will also serve as the medical safety expert on cross-functional development teams, working closely with internal and external stakeholders to ensure compliance with regulations and guidelines, contribute to safety regulatory documents, and protect participant safety.

The successful candidate will combine strong clinical judgment and pharmacovigilance expertise with a team-oriented approach suited to a growing biotechnology company. The role will also help develop Oruka’s pharmacovigilance infrastructure, processes, governance, and vendor partnerships as the portfolio advances through clinical development and toward registration.

Key Responsibilities

Product Safety Leadership and Risk Management

• Develop and lead product safety surveillance strategies, identify emerging clinical safety issues, and recommend appropriate risk-mitigation measures.
• Conduct or oversee routine and ad hoc reviews of safety data, monitor for safety signals, and maintain awareness of relevant drug-class and competitor safety issues.
• Lead ongoing aggregate safety review and chair internal safety governance committees.
• Plan and interpret safety data analyses; prepare and present safety data summaries to internal and external stakeholders.
• Build effective working relationships with clinical study teams, safety vendors, and business partners to align on product safety str

[…]
ent Pharmacovigilance during regulatory inspections, audits, and due-diligence activities.

Required Qualifications

• Medical degree (MD/DO or equivalent) with completed residency.
• Minimum of 6 years of safety experience within the pharmaceutical industry.
• Strong expertise in global pharmacovigilance regulations and requirements.
• Demonstrated ability to work effectively in a dynamic, cross-functional, and fast-paced team environment.
• Proficient with safety surveillance systems and tools (e.g., Argus, MedDRA, Veeva Vault)
• Ability to work effectively in a dynamic, cross-functional, and fast-paced team environment.
• Excellent communication, leadership, and analytical skills.

Compensation

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for candidates, who will work remotely or Waltham, MA is $306,000 to $343,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states. If candidate is remote travel expectation will be up to 20% of the time.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.
Salary Range for the Role
$306,000 — $343,000 USD

What We Offer

• A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.
• Competitive salary and benefits package.
• A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.
• Opportunities for professional growth and development.