---
title: 'Trial Master File (TMF) Associate at Oruka Therapeutics'
canonical: 'https://feeny.ai/job/trial-master-file-tmf-associate-oruka-therapeutics-menlo-park-california-m7m73f19sw65'
type: 'job'
last_seen: '2026-09-16'
---

# Trial Master File (TMF) Associate at Oruka Therapeutics

- **Company:** Oruka Therapeutics
- **Location:** Menlo Park California, United States / Waltham Massachusetts, United States
- **Compensation:** $104k–$125k
- **Work type:** remote
- **Posted:** 2026-09-11
- **Last confirmed live:** 2026-09-16
- **Apply:** https://job-boards.greenhouse.io/oruka/jobs/5422688008

## 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:     Trial Master File (TMF) Associate

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

Job Summary

We are seeking a highly organized and detail-oriented Trial Master File (TMF) Associate to support the management, quality, and inspection readiness of clinical trial documentation throughout the clinical study lifecycle. The TMF Associate serves as a key partner to Clinical Operations, CROs, vendors, and study teams, ensuring TMF records are complete, accurate, contemporaneous, and maintained in accordance with ICH-GCP guidelines, regulatory requirements, and company procedures. This role contributes to TMF oversight activities, quality reviews, reconciliation efforts, health metric reporting, and continuous process improvement initiatives to support an inspection-ready TMF environment.

Responsibilities:

- Maintain assigned study TMFs and ensure documents are filed accurately, contemporaneously, and according to TMF standards and company procedures.
- Perform routine quality control reviews to identify missing, incomplete, duplicate, or misfiled documents and drive timely resolution with study teams and functional areas.
- Monitor TMF health, completeness, and timeliness metrics; proactively communicate risks, trends, and outstanding issues to stakeholders.
- Partner with Clinical Operations, CROs, vendors, and cross-functional teams to ensure consistent document flow and adherence to TMF filing expectations.
- Support vendor and CRO reconciliation activities and assist with management of TMF transfer processes to ensure documentation completeness across all sources.
- Assist in preparing for audits and regulatory inspections by ensuring TMF documentation is complete, accessible, and inspection-ready.
- Track, reconcile, and help resolve TMF queries, issues, and corrective actions in collaboration with study teams and vendors.
- Support TMF plans, filing guidance, work instructions, SOPs, and other TMF-related documentation as needed.
- Assist with user support, training, and adoption of eTMF processes and systems.
- Contribute to TMF process improvements and quality initiatives that enhance compliance, efficiency, and inspection readiness.
- Maintain compliance with company SOPs, ICH-GCP guidelines, and applicable regulatory requirements.

Requirements:

- Bachelor's degree in Life Sciences, Health Sciences, or related fields or equivalent.
- 2-4+ years of experience in TMF management, clinical document management, clinical operations, or clinical research within biotechnology, pharmaceutical, or CRO environments.
- Working knowledge of the CDISC TMF Standard Model, ICH-GCP R(3) guidelines, 21 CFR Part 11, and applicable FDA and global regulatory requirements.
- Experience maintaining electronic Trial Master Files (eTMF) in regulated clinical trial environments.
- Hands-on experience with Veeva Vault eTMF and/or Trial Interactive platforms required.
- Experience with TMF quality control, completeness reviews, reconciliation activities, and inspection readiness support.
- Ability to analyze TMF health metrics and identify risks, trends, and gaps requiring follow-up.
- Demonstrated commitment to quality, compliance, and continuous improvement.

Preferred Requirements:

- Experience supporting FDA BIMO regulatory inspections.
- Experience supporting global clinical studies across multiple phases and working directly with CROs and external vendors.
- Familiarity with CTMS platforms and TMF-related inspection preparation activities.
- Experience supporting SOP development, TMF training, or process improvement initiatives.

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 Associate level is $104,000 - $125,000. 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.

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 $104,000—$125,000 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

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