{"id":1259275,"url":"https://alion.io/job/argenx-clinical-operations-development-lead-2","title":"Clinical Operations Development Lead","company":{"id":1805561,"name":"argenx","domain":"argenx.com","url":"https://alion.io/company/argenx","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":77,"open_postings":14,"ghost_share":0,"stale_share":0.929,"repost_share":0,"time_to_fill_p50_days":29,"computed_at":"2026-10-15T05:46:00Z"}},"role":"Sales","role_family":"Sales","seniority":"lead","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Ghent, Belgium","Switzerland"],"countries":["BE","CH"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":15,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GCP","optional":false}],"status":"live","first_seen_at":"2026-06-15T00:00:00Z","employer_posted_date":"2026-06-15","last_verified_at":"2026-10-16T00:10:50Z","board_verified":true,"closed_at":null,"days_open":123,"trust":{"level":"stale","repost_count":0,"flags":["stale"],"days_open":122},"description":"Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases.\nWe are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients.\nThe Clinical Operations Development Lead (CODL) is a key member of the Indication Development Team (IDT), overseeing clinical activities for a specific therapeutic indication (CODL) or across all indications for an asset (early/late phase CODL). The CODL provides operational input and drives strategy for clinical development across the lifecycle of an asset, from First in Human (FIH) studies through registration and post-approval clinical development activities. Responsibilities include but not limited to: managing clinical trial budgets, timelines, and resources (including line management), and providing input to trial design and regulatory authority strategy and interactions The CODL drives operational risk management, cross-functional I implementation, problem solving and escalation. The CODL may lead the IDT, ensuring effective decision-making and team performance towards the indication and company Objectives, goals, strategies and measures (OGSMs).\nROLES AND RESPONSIBILITIES (non-exhaustive list)\nProvides operational expertise and strategic input to the Clinical Development Plan (CDP) in collaboration with other IDT representatives. Ensures the CDP describes the clinical development strategy, comprising effective and, where possible, innovative trial designs and is consistent with the Target Product Profile (TPP).\nProvides input to the Objectives, Goals, Strategies and Measures (OGSM).\nAccountable for the conduct of all clinical related aspects within the assigned therapeutic indication/program. Ensure the execution is done in line with the agreed OGSMs, timelines, budget, quality standards, ICH-GCP and applicable regulations, Standard Operation Procedures (SOPs) and Work Instructions (WIs).\n Act as primary point of contact for all operational clinical related activities at indication level and as escalation point for trial level activities.\nIn collaboration with the other IDT members, identifies risks, ensures that these are reflected in applicable risk registers and drives their mitigation. Works with the Project Manager (PM) and IDT members to decide which risks and issues are to be brought to the attention of the asset Project Leader (PL) and the Development Management Committee (DMC). Pro-actively provides solutions and oversees implementation and follow-up.\nEnsures that the Franchise Clinical Operations Development Lead (FCODL) and Global Head of Trial Operations are informed in case an identified issue/risk could have an impact on/may also occur in the other therapeutic indications/programs. In case of an asset specific impact, involve FCODL and peer CODL(s), AST, and PM as needed.\nEnsures consistency and efficiency in trial set-up and conduct across the different trials within the specific indication(s).\nDrives the timely production of a qualitative Clinical Trial Protocol Concept Sheet.\nCollaborates with the Clinical Trial Leads (CTLs) and Clinical Trial Managers (CTM) and their respective Clinical Trial Teams (CTTs) to ensure timely availability of qualitative documents defining the design and the execution of the clinical program (e.g. protocol/protocol amendments, operationalization plans and tools). Active CODL input to the CTT may be needed until the team is fully resourced.\n Works towards initial country and site selection, oversees the actual selection and ensures that the AST and IDT are kept informed on the final selection.\nParticipates in the Clinical Research Organization (CRO) and collaborator/supplier selection and management process. Supports CTT with issue resolution in collaboration with alliance and sourcing manager if relevant.\nReviews and provides input to the overarching clinical program/indication documents such as Pediatric Investigation Plan (PIP), Diversity Action Plan (DAP) and regulatory documents.\nAccountable for the clinical trial budgets and timelines and support resource requirements, collaborating with the indication Project Manager (PM), the Finance business partner (FBP) and the sourcing manager.\nInforms the IDT in case the timelines or budget deviate from projected and partners with IDT members to review and discuss status and impact of change(s), brings options forward to resolve these and ensure these are subject to governance endorsement as needed.\nProvide input to the program dashboards to ensure accurate status updates on key milestones achieved and planned, issues/risks and financial status.\nEnsures audit/inspection preparation and readiness of the assigned program/trials. Support audits and inspections.\nSupports continuous improvement processes and consistency e.g., by ensuring that lessons learned are shared across trials within the assigned therapeutic indication, across indications as well as across assets in collaboration with the FCODL and the Global Head of Trial Operations, if applicable.\nAs a Leader, sets expectations, communicates in a transparent, clear way and energizes team members to work towards achieving the project goals.\nCoaching of CTLs/CTMs:On-boarding of new joiners\nGoal setting and continuous feedback \nMentoring and enabling the growth and development\n\nSupport Trial Operations and Global Company initiatives (including interviewing candidates).\nRole models the argenx cultural pillars and operating principles: humility, co-creation, drives excellence and innovation, empowers team members.\nSKILLS AND COMPETENCIES\nThe CODL excels in leadership and establishing good and effective internal and external working relationships and communication, embedding the argenx values.\nGlobal Strategic Drug Development experience and understanding.\nStrong interpersonal and stakeholder management skills.\nProven Clinical Operations experience in a relevant global leadership position in the pharmaceutical/biotech industry.\nPro-active problem solver - demonstrated ability to identify and resolve issues, identify and mitigate risks, able to handle conflicts.\nStrong organizational skills, able to deal with complexity and ambiguity, manage multiple and varied tasks and prioritize workload with attention to the holistic/ helicopter view but also able to dive into the details when needed.\nStrong people management skills, leadership skills and team player.\nExcellent written and verbal communication skills, acting globally in a culturally diverse dynamic team.\nStrong literacy in English\nThorough knowledge of ICH GCP guidelines and other applicable regulatory requirements and guidelines.\nEDUCATION, EXPERIENCE and QUALIFICATIONS\nBachelor’s or master’s degree - medical or para-medical (Biology, Biomedical Sciences, Pharmacy, Veterinary etc.) or equivalent by experience.\nMinimum of 15 years of leadership experience in Clinical Development (monitoring, local and global/international trial management).\nExperience in working in an outsourced model, including overseeing CROs and collaborators.\nRare disease and/or auto-immune clinical trial background is a plus.\n\n\nNote: The recruiter will share the locally applicable annual base salary hiring range, provided in your country’s currency, during the recruitment process. This information will reflect market conditions, role scope, and internal guidelines specific to your location.\nThis job is eligible to participate in our short-term and long-term incentives program.\nThe hiring range displayed above is the range of possible base pay compensation that argenx believes in good faith it will pay for this role at the time of this posting. The hiring range is based on the job grade for this position. Individual compensation paid within this range depends on a variety of factors, including, but not limited to, internal equity, prior education and experience, job-related knowledge and demonstrated skills. argenx may pay more or less than the posted range and this range may be modified in the future.\nAt argenx, all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer.\nBefore you submit your application, CV or any other personal details to us, please review our argenx Privacy Notice for Job Applicants to learn more about how argenx B.V. and its affiliates (“argenx”) will handle and protect your personal data. If you have any questions or you wish to exercise your privacy rights, please contact our Global Privacy Office by email at .","description_format":"text","description_chars":9338,"description_truncated":false,"requirements":{"experience_years_min":15,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Equity"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Health Care","Professional Services"],"lifecycle":[{"event":"open","at":"2026-09-25T19:57:25Z"}],"visa":[],"liveness":{"score":8,"band":"cold","label":"Long shot","p_open":1,"p_active":0.287,"p_room":0.28,"age_days":122,"expected_fill_days":29,"reasons":["conf:7","stale_co","win:tail","crowd:"],"computed_at":"2026-10-15T05:46:00Z"},"pay":null,"html_url":"https://alion.io/job/argenx-clinical-operations-development-lead-2","json_url":"https://alion.io/job/argenx-clinical-operations-development-lead-2.json","meta":{"generated_at":"2026-10-16T04:16:45Z","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":1006,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-17T00:00:00Z"}},"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":1805561},"rest":"https://alion.io/mcp/rest/get_company?id=1805561"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fargenx-clinical-operations-development-lead-2"},{"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%2Fargenx-clinical-operations-development-lead-2"},{"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%2Fargenx-clinical-operations-development-lead-2"},{"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/argenx-clinical-operations-development-lead-2\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fargenx-clinical-operations-development-lead-2"}]}