{"id":885371,"url":"https://alion.io/job/oruka-director-clinical-operations","title":"Director, Clinical Operations","company":{"id":688198,"name":"Oruka Therapeutics","domain":"oruka.com","url":"https://alion.io/company/oruka","size_band":"1-10","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":{"grade":"A","score":95,"open_postings":7,"ghost_share":0,"stale_share":0,"repost_share":0,"time_to_fill_p50_days":143,"computed_at":"2026-11-03T05:54:40Z"}},"role":"Biotech","role_family":"Biotech","seniority":"head","employment_type":null,"work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Waltham, United States","Menlo Park, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":213000,"max":240000,"currency":"USD","period":"year","gross":null,"usd_annual":240000},"salary_estimate":null,"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GCP","optional":false},{"name":"Good Clinical Practice","optional":false},{"name":"Microsoft Office","optional":false}],"status":"closed","first_seen_at":"2026-05-29T19:31:16Z","employer_posted_date":"2026-06-03","last_verified_at":"2026-10-28T17:49:03Z","board_verified":false,"closed_at":"2026-10-28T17:49:03Z","days_open":151,"trust":{"level":"ok","repost_count":0,"flags":[],"days_open":151},"description":"About Us: \nOruka 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\nAs 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. \nJob Title: Director, Clinical Operations\nLocation: Waltham, MA Hybrid - onsite 3 days/week required\nReports To: Vice President, Clinical Operations\n\nRole Overview:\nWe are seeking an exceptionally nimble and flexible Director of Clinical Operations who has a track record of achievement across all aspects of trial setup and execution in a fast paced small biotech with limited infrastructure and resources. The individual will successfully lead and optimize activity across multiple studies for Oruka Therapeutics. This critical role demands a strategic leader who possesses a keen ability to \"zoom in\" on intricate operational details while simultaneously \"zooming out\" to maintain a holistic view of program progress and timelines. The successful candidate will be a proactive problem-solver, adept at navigating complexities, anticipating challenges, and implementing agile solutions to ensure our clinical trials remain on schedule and within budget. We are looking for a candidate that can demonstrate a high degree of integrity, pragmatism and is laser focused on commitment to study goals. You should be comfortable being a ‘player/coach’ taking on tactical tasks as required in support of the program.\nKey Responsibilities:\nStrategic Oversight & Agility in Clinical Study Planning, Management and Execution:\nDevelop and implement strategic operational plans for clinical trials, ensuring alignment with program goals and business objectives.\nProactively identify potential risks, bottlenecks, and deviations from timelines, and swiftly implement corrective actions with a flexible and adaptable approach.\nDemonstrate the ability to rapidly assess evolving circumstances (e.g., regulatory changes, unexpected site challenges, vendor issues) and adjust operational strategies accordingly.\nMaintain a high-level overview of all assigned clinical trials, understanding interdependencies and potential impacts on overall program timelines.\nOperational Excellence & Detailed Focus in Conducting Clinical Trials:\nProvide expert operational guidance and oversight for all phases of clinical trials, from study startup through close-out.\nPossess the ability to delve into granular operational details when necessary to identify root causes and inform strategic decisions.\nEnsure adherence to Good Clinical Practice (GCP), regulatory requirements, Standard Operating Procedures (SOPs), and company policies.\nOversee the selection, qualification, and management of Contract Research Organizations (CROs) and other third-party vendors, ensuring their performance meets expectations and timelines.\nMaintain oversight of clinical operations budgets, including regular forecasting and internal reporting to management and finance\nSupport supply chain planning and management with both clinical and non-clinical supplies for trial execution.\nTimeline Management & Proactive Problem Solving in Executing Clinical Trial Programs:\nLead and manage clinical trial timelines, ensuring key milestones are met and proactively mitigating any delays.\nImplement robust tracking and reporting mechanisms to monitor trial progress and identify potential deviations early.\nDevelop and execute contingency plans to address unforeseen challenges and keep trials on track.\nFacilitate effective communication and collaboration across cross-functional teams to drive trial progression.\nOperate as a “Hands-On” Leader & Develop Teams in a Fast-Paced Environment:\nWe need a hands-on leader who can contribute individually to deliverables and meet deadlines to hit ORUKA milestones.\nFoster a culture of accountability, continuous improvement, and proactive problem-solving within the clinical operations group.\nRepresent Clinical Operations in internal and external meetings, contributing to strategic discussions and decision-making.\nQualifications:\nBA/BS required in a scientific/medical field preferred\nA minimum of 10+ years of experience in managing global clinical trials at all stages of development\nExperience in immunological and dermatologic disease areas welcome\nCapable of managing direct reports from afar and study team members across multiple time zones and cultures\nDemonstrated ability to successfully manage and deliver clinical trials from start-up through close-out, including all financial tracking and reporting activities\nDemonstrated successful management and oversight of CROs and other service providers\nDeep understanding of clinical trial design, protocol development/ review, and running the clinical trial meetings\nSignificant experience with cross-functional leadership and clinical teams, including leading data review, protocol deviation review, database lock, CSR development, and study reporting activities\nStrong vendor management experience required\nExperience in the management and maintenance of EDC, CTMS, IRT, ePRO, etc.\nExperience with Quality Assurance, SOP and Study Plans writing, CAPA preparation, and closure\nExperience with a submission-ready eTMF, regulatory inspections and/or inspection-readiness activities\nStrong knowledge of GCP and working knowledge in ICH GCP E6 R2 regulations\nStrong project management experience and skills is preferred\nDemonstrate strong leadership, collaboration and cross-functional management skills, ability to multi-task in a dynamic and fast-paced environment\nStrong interpersonal, negotiation, influencing, problem-solving skills\nExcellent written and verbal skills required\nWilling to travel domestically and internationally up to 25% of the time\nProficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirable\nStrong computer and database skills\nClear and concise oral and written communication skills\nExcellent organizational skills and experience prioritizing conflicting demands\nCritical thinking, problem solving, ability to work independently.\nConsistently operate with urgency, clarity and conciseness\nCommunicate effectively and articulate complex ideas in an easily understandable way\nCompensation:\nAn appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.\nThe anticipated salary range for candidates is $213,000 - $240,000. 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. \nLocation: Waltham, MA Hybrid - onsite 3 days/week required\nSalary Range for the Role\n$213,000—$240,000 USD\nWhat We Offer:\nA chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.\nCompetitive salary and benefits package.\nA supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.\nOpportunities for professional growth and development.","description_format":"text","description_chars":7999,"description_truncated":false,"requirements":{"experience_years_min":10,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":["Equity"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Biologics & Biosimilars","Immunology & Inflammation Therapeutics"],"lifecycle":[{"event":"open","at":"2026-09-14T03:41:33Z"},{"event":"close","at":"2026-10-28T17:49:03Z"}],"visa":[],"liveness":null,"pay":{"stated_usd_annual":240000,"is_top_pay":false},"html_url":"https://alion.io/job/oruka-director-clinical-operations","json_url":"https://alion.io/job/oruka-director-clinical-operations.json","meta":{"generated_at":"2026-11-04T04:01:39Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":6216,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-05T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":688198},"rest":"https://alion.io/mcp/rest/get_company?id=688198"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Foruka-director-clinical-operations"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Foruka-director-clinical-operations"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Foruka-director-clinical-operations"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/oruka-director-clinical-operations\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Foruka-director-clinical-operations"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":885371}},{"tool":"search_jobs","arguments":{"company":"oruka.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":885371},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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