---
title: 'Senior Medical Director, Pharmacovigilance and Safety at Oruka Therapeutics'
canonical: 'https://feeny.ai/job/senior-medical-director-pharmacovigilance-and-safety-oruka-therapeutics-waltham-gp7z8xyv17a8'
type: 'job'
last_seen: '2026-11-04'
---

# Senior Medical Director, Pharmacovigilance and Safety at Oruka Therapeutics

- **Company:** Oruka Therapeutics
- **Location:** Waltham, MA
- **Compensation:** $306k–$343k
- **Work type:** remote
- **Posted:** 2026-09-25
- **Last confirmed live:** 2026-11-04
- **Apply:** https://job-boards.greenhouse.io/oruka/jobs/5435091008

## Job description

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](http://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 if located near Waltham, MA office and will be required to be in-office in 3 days/week.

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 strategy.

Medical Safety Oversight

- Oversee expedited safety reporting, including medical review of Individual Case Safety Reports (ICSRs), suspected unexpected serious adverse reactions (SUSARs), and other reportable safety events.
- Ensure appropriate medical follow-up and consistent medical assessment of individual safety cases.
- Provide medical review of clinical trial safety data, including adverse events, laboratory results, vital signs, ECGs, exposure data, and relevant nonclinical or external information.
- Provide medical safety guidance to investigators, study teams, and internal stakeholders.

Clinical Development and Regulatory Support

- Lead safety-related aggregate reporting and the preparation and maintenance of relevant sections of Investigator's Brochures, including Reference Safety Information, Development Safety Update Reports, Risk Management Plans, and other regulatory documents.
- Provide safety input into clinical development plans, study protocols, informed consent forms, case report forms, statistical analysis plans, data-monitoring plans, and clinical study reports.
- Represent Pharmacovigilance in correspondence and meetings with the FDA and other global regulatory authorities.
- Maintain current knowledge of global pharmacovigilance regulations and guidance and ensure activities comply with applicable requirements, standard operating procedures, and other internal guidelines.

Pharmacovigilance Infrastructure and External Partnerships

- Help build and continuously improve Oruka’s pharmacovigilance system as the company and clinical portfolio grow.
- Oversee pharmacovigilance vendors supporting case processing, safety-database management, aggregate reporting, and literature surveillance.
- Set clear vendor expectations, monitor quality and performance, and ensure timely resolution of issues
- Provide safety leadership for independent data monitoring committees and adjudication committees, including development of charters, data-review plans, meeting materials, and recommendations.
- Support inspection readiness and represent 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.

## About Oruka Therapeutics

## Company Overview
- **One-liner**: Oruka Therapeutics is a clinical-stage biotechnology company developing potentially best-in-class monoclonal antibodies with extended half-lives to transform the treatment of psoriasis and other chronic inflammatory skin diseases by enabling high rates of complete disease clearance with as few as one or two doses per year.
- **Entity Type**: Public (Nasdaq: ORKA)
- **Headquarters**: Waltham, Massachusetts, United States (with a second office in Menlo Park, California)
- **Founded**: Not publicly available
- **Founders**: Not publicly available (the company was formed as a spinout of Paragon Therapeutics, which discovered its antibody pipeline)

## Core Business
- **Primary industry**: Biotechnology – dermatology and inflammatory disease therapeutics
- **Target customers**: Patients with plaque psoriasis, psoriatic arthritis, hidradenitis suppurativa, and other inflammatory conditions; physicians and healthcare providers; payers and health systems
- **Mission**: *“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.”* [orukatx.com](https://orukatx.com/)

## Products & Services
- **ORKA-001**: An investigational monoclonal antibody targeting IL-23p19, engineered for extended circulation time. Designed as a potentially best-in-class therapy for moderate-to-severe plaque psoriasis, with the potential for dosing once or twice per year. Currently in Phase 2b clinical trial (EVERLAST-B). [orukatx.com](https://orukatx.com/our-pipeline/)
- **ORKA-002**: An investigational monoclonal antibody targeting IL-17A/F, also engineered for half-life extension. Aimed at psoriasis, psoriatic arthritis, and hidradenitis suppurativa, with potential dosing two to three times per year. Currently in Phase 1/2. [orukatx.com](https://orukatx.com/our-pipeline/)
- **ORKA-003**: A preclinical sequential combination regimen of ORKA-002 and ORKA-001, designed to deliver rapid responses with an ideal maintenance profile. [orukatx.com](https://orukatx.com/our-pipeline/)
- **ORKA-021**: Preclinical stage candidate (details not fully disclosed). [orukatx.com](https://orukatx.com/our-pipeline/)

## Market Standing
- **Valuation/Market Cap**: Not publicly available at this time (company went public via IPO; market cap fluctuates daily). Latest financial data should be obtained from SEC filings.
- **Key Metric**: As a clinical-stage public company, Oruka has no approved products yet. Funding and operational runway are funded by its IPO proceeds; exact amounts not provided in search results.
- **Notable Investors/Partners**: Discovery and engineering partner: Paragon Therapeutics (also parent of Apogee Therapeutics and Spyre Therapeutics). Investor base includes public market shareholders post-IPO.
- **Growth Signals**: 
  - Two co-lead programs advancing through clinical trials (Phase 1 data expected; Phase 2 ongoing).
  - Team expanding rapidly, with multiple job openings across scientific, clinical, and corporate functions.
  - Dual-location offices (Boston area and Bay Area) to attract top biotech talent.

## Competitive Advantages
- **Advanced antibody engineering**: Incorporates half-life extension technology (e.g., YTE mutations) to dramatically prolong circulation time, aiming for the longest dosing intervals in the class (1–2 doses per year vs. standard 4–12 times per year).
- **Proven mechanisms**: Targets IL-23p19 and IL-17A/F—validated, blockbuster pathways in psoriasis—but with enhanced pharmacokinetics to maximize efficacy and patient convenience.
- **Discovery engine**: Pipeline originated from Paragon Therapeutics, a proven antibody engineering shop that also spawned Apogee and Spyre, indicating a repeatable model for creating best-in-class molecules.
- **Focus on complete clearance**: Emphasizes “complete disease clearance” (e.g., PASI 100) as a goal, not just improvement—a higher bar than many current treatments.

## Strategic Focus
- **Near-term**: Generate Phase 1 safety and pharmacokinetics data for ORKA-001 and ORKA-002; advance EVERLAST-B (Phase 2b for ORKA-001) and ORCA-SURGE (Phase 2 for ORKA-002); initiate trials in additional indications (psoriatic arthritis, hidradenitis suppurativa).
- **Long-term**: Build a fully integrated biopharmaceutical company capable of commercializing novel biologics, potentially expanding beyond dermatology into other inflammatory diseases.
- **Organizational growth**: Aggressively hiring across all functions (clinical development, medical affairs, regulatory, CMC, finance, BD, etc.) to scale from early-stage to late-stage organization.

## Why Work Here
- **Mission-driven**: A chance to directly impact millions of patients living with chronic skin diseases—offering the potential for life-changing freedom from disease.
- **Startup culture with public-company resources**: Small, nimble team (“wear multiple hats”) but with the backing of a Nasdaq listing, equity grants, and competitive compensation.
- **Flexible work environment**: Remote-first policy with hybrid options (3 days/week) if located near Waltham, MA or Menlo Park, CA offices. [greenhouse.io](https://job-boards.greenhouse.io/oruka/jobs/5202407008)
- **Compensation & benefits**: Competitive base salary (e.g., Senior Scientific Communications Manager salary range $161k–$187k), equity, performance bonus, and professional development opportunities. [greenhouse.io](https://job-boards.greenhouse.io/oruka/jobs/5202407008)
- **Team culture**: Described as “vibrant startup culture,” “supportive and inclusive,” with emphasis on bringing “authentic selves to work.” Opportunities for growth in a fast-moving, high-autonomy environment.
- **Top-tier location**: Offices in both the Boston/Cambridge biotech hub and the Bay Area, giving employees access to two of the strongest life science ecosystems.

## Sources
1. [orukatx.com – Home](https://orukatx.com/)
2. [orukatx.com – Who We Are](https://orukatx.com/who-we-are/)
3. [orukatx.com – Pipeline](https://orukatx.com/our-pipeline/)
4. [orukatx.com – Join Us](https://orukatx.com/join-us/)
5. [greenhouse.io – Senior Scientific Communications Manager job posting](https://job-boards.greenhouse.io/oruka/jobs/5202407008)

## Other roles at Oruka Therapeutics

- [Manager, Clinical Data Management](https://feeny.ai/job/manager-clinical-data-management-oruka-therapeutics-remote-2s40n9dfy7z3)
- [Senior Manager, Clinical Supply Chain – Biologics](https://feeny.ai/job/senior-manager-clinical-supply-chain-biologics-oruka-therapeutics-waltham-qkhs36pe1jg1) — Waltham, MA
- [Associate Director, Biostatistics](https://feeny.ai/job/associate-director-biostatistics-oruka-therapeutics-menlo-park-c0nn31kzkjdv) — Menlo Park, CA / Waltham, MA
- [Director of Biostatistics](https://feeny.ai/job/director-of-biostatistics-oruka-therapeutics-menlo-park-p1gj4dc26c6d) — Menlo Park, CA / Waltham, MA
- [Senior Engineer/Manager, Device Development — Combination Products](https://feeny.ai/job/senior-engineer-manager-device-development-combination-products-oruka-9vxkzfje9s3m) — Waltham, MA
- [Medical Director, Clinical Development](https://feeny.ai/job/medical-director-clinical-development-oruka-therapeutics-waltham-90d1jacw6dyb) — Waltham, MA
- [Pharmacovigilance Scientist](https://feeny.ai/job/pharmacovigilance-scientist-oruka-therapeutics-waltham-6sn2jm3x9as4) — Waltham, MA
- [Clinical Scientist, Clinical Development](https://feeny.ai/job/clinical-scientist-clinical-development-oruka-therapeutics-remote-18t9akrxe2tm)
- [Manager/Senior Manager of Statistical Programming](https://feeny.ai/job/manager-senior-manager-of-statistical-programming-oruka-therapeutics-waltham-t1q186jwkqt7) — Waltham, MA
- [Senior Manager/Associate Director Clinical Monitoring Strategy & Optimization](https://feeny.ai/job/senior-manager-associate-director-clinical-monitoring-strategy-optimization-fz8n0jqr0913) — Menlo Park, CA / Waltham, MA