--- title: 'Senior Manager/Associate Director Clinical Monitoring Strategy & Optimization at Oruka Therapeutics' canonical: 'https://feeny.ai/job/senior-manager-associate-director-clinical-monitoring-strategy-optimization-fz8n0jqr0913' type: 'job' last_seen: '2026-09-09' --- # Senior Manager/Associate Director Clinical Monitoring Strategy & Optimization at Oruka Therapeutics - **Company:** Oruka Therapeutics - **Location:** Menlo Park California, United States / Waltham Massachusetts, United States - **Compensation:** $161k–$208k - **Work type:** remote - **Posted:** 2026-07-27 - **Last confirmed live:** 2026-09-09 - **Apply:** https://job-boards.greenhouse.io/oruka/jobs/5370435008 ## 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: Sr. Manager/Associate Director, Clinical Monitoring Strategy and Optimization Location: Remote OR Hybrid 3 days/week if located near office in either Waltham, MA or Menlo Park, CA will be required. Role Overview: We are seeking an experienced and highly motivated Sr. Manager/Associate Director of Clinical Monitoring Strategy and Optimization to provide strategic and operational leadership for clinical monitoring activities across our development programs. This individual will play a critical role in building and scaling clinical operations infrastructure within a fast-paced emerging biotech environment. The successful candidate will oversee CRO monitoring performance, ensure high-quality execution of clinical trials, and contribute to the development of monitoring processes, vendor oversight strategies, and inspection readiness activities. This role requires a hands-on leader who is comfortable operating both strategically and tactically in a lean organization. Key Responsibilities: Clinical Monitoring Leadership - Lead and oversee clinical monitoring activities for Phase 1–3 clinical trials conducted globally and/or domestically. - Serve as the internal expert for monitoring strategy, site management, and risk-based monitoring approaches. - Provide oversight and management of CROs, CRAs, and other external vendors to ensure quality, timelines, and budget adherence. - Review monitoring plans, trip reports, metrics, and monitoring deliverables for quality and compliance. - Partner cross-functionally with Clinical Development, Clinical Science, Data Management, Biostatistics, Medical Writing, Pharmacovigilance, Regulatory Affairs, and Quality Assurance. Vendor and CRO Oversight - Establish effective CRO oversight and governance processes. - Monitor CRO performance through KPIs, metrics, and regular operational reviews. - Escalate and resolve study conduct issues proactively. - Participate in vendor selection, qualification, and contract review activities. Trial Execution and Compliance - Ensure studies are conducted in compliance with ICH-GCP, SOPs, protocol requirements, and applicable regulations. - Support development and review of key study documents including Monitoring Plans, Risk Management Plans, Study Oversight Plans, Clinical Trial Management Plans, and Site Management Plans. - Contribute to inspection readiness activities and support regulatory inspections and audits. Operational Process Development - Help build scalable clinical monitoring infrastructure appropriate for a growing biotech company. - Develop and refine SOPs, work instructions, templates, and monitoring processes. - Drive continuous improvement initiatives focused on quality, efficiency, and operational excellence. - Implement and optimize risk-based monitoring methodologies and centralized monitoring approaches where appropriate. ## Team Leadership and Mentorship - May directly manage CRAs and/or Clinical Trial Managers as the organization grows. - Mentor junior clinical operations staff and contribute to team development. - Foster a collaborative, accountable, and quality-focused culture. Qualifications: Required - Bachelor’s degree in life sciences, nursing, or related discipline. - 6-8+ years of clinical operations experience within biotech, pharmaceutical, or CRO environments. - Significant experience overseeing clinical monitoring activities in interventional clinical trials. - Strong knowledge of ICH-GCP, FDA, EMA, and global regulatory requirements. - Experience managing CROs and external vendors. - Demonstrated ability to work effectively in a small, fast-moving biotech environment. - Excellent communication, organizational, and problem-solving skills. - Extensive domestic and international travel as needed (approximately 60-80%). ## Preferred - Bachelor’s degree or equivalent required. - Advanced degree (MS, MPH, PharmD, PhD, or RN) preferred. - Experience in rare disease, immunology, oncology, or other relevant therapeutic areas. - Experience supporting NDA/BLA-enabling studies and regulatory inspections. - Experience implementing risk-based monitoring strategies and oversight models. - Prior people management experience. Desired Leadership Competencies - Strategic thinker with strong execution skills - Comfortable with ambiguity and rapid change - Hands-on and solutions-oriented - Strong collaborator and relationship builder - High attention to detail and commitment to quality - Ability to influence cross-functional teams and external partners 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 Sr. Manager is $161,000 - $187,000 and for Associate Director level is $182,000 - $208,000. 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. Location: Remote OR Hybrid 3 days/week if located near office in either Waltham, MA or Menlo Park, CA will be required. 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 $161,000—$208,000 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 - [Sr. Associate/Manager Project Management & Operations](https://feeny.ai/job/sr-associate-manager-project-management-operations-oruka-therapeutics-waltham-vkjrt9srrzv7) — Waltham Massachusetts, United States - [Associate Director, Regulatory CMC (Biologics)](https://feeny.ai/job/associate-director-regulatory-cmc-biologics-oruka-therapeutics-waltham-8tegt1p70qg9) — Waltham Massachusetts, United States - [Associate/Sr. Associate - CMC Project Management & Operations](https://feeny.ai/job/associate-sr-associate-cmc-project-management-operations-oruka-therapeutics-nxqjhp0d3ycd) — Waltham Massachusetts, United States - [Associate Director/Director, Clinical Pharmacology](https://feeny.ai/job/associate-director-director-clinical-pharmacology-oruka-therapeutics-remote-mszse4yzs07a) - [Administrative Assistant](https://feeny.ai/job/administrative-assistant-oruka-therapeutics-waltham-w7s67gb88efv) — Waltham, MA - [Sr. Manager/Associate Director, Regulatory Affairs](https://feeny.ai/job/sr-manager-associate-director-regulatory-affairs-oruka-therapeutics-menlo-park-810qkwnjxqp4) — Menlo Park, CA / Waltham, MA - [Director, Clinical Operations](https://feeny.ai/job/director-clinical-operations-oruka-therapeutics-waltham-massachusetts-dmf2nbp3y8nt) — Waltham Massachusetts, United States - [Director of Biostatistics](https://feeny.ai/job/director-of-biostatistics-oruka-therapeutics-remote-v8hjmy2gjd5v) - [Medical Science Liaison-Southeast](https://feeny.ai/job/medical-science-liaison-southeast-oruka-therapeutics-remote-0tptf8yxr814) - [Medical Science Liaison-South Central](https://feeny.ai/job/medical-science-liaison-south-central-oruka-therapeutics-remote-4j3fngt21w29)