Franchise Clinical Operations Development Lead (CODL)

ppJoin 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. /p pWe 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. /p h3Roles And Responsibilities /h3 ul liOversee the CODLs who provide strategic input and are accountable for all clinical related aspects within the assigned therapeutic indication/program, in line with the agreed timelines, budget and quality standards and as outlined in the applicable Standard Operation Procedures (SOPs) and Work Instructions (WIs). /li liOversee the Clinical development Plan (CDP) creation for all indications within the franchise. The CDP is co-created by the CODL and the Medical Development Lead (MDL), with support from the Project Manager (PM) and other Clinical Development Team (CDT) representatives. The indication CDP describes the clinical development strategy, includes effective and, where possible, innovative trial designs and is consistent with the TPP. The CDP is endorsed by the Asset Strategy Team (AST) and the Development Management Committee (DMC) and is executed within agreed timelines and budget /li liThe Franchise CODL can temporarily take on the role of an CODL for an indication within the franchise. Please refer to the Job Description of the CODL for further details on the CODL role. /li liActs as senior point of contact for all clinical related activities for a given Franchise across asset indications. Collaborate with the asset teams as applicable. /li liFocus on risks and mitigations on the franchise level. Ensures that the Global Head of Trial Operations is informed in case an identified issue/risk could have an impact on/may also occur in, the other therapeutic indications/programs / franchises. Involve the X-indication CODL, AST and PM as needed. /li liOperationalize knowhow and synergies at the franchise level, ensure knowhow is shared with different indication teams. /li liEnsure optimal implementation of lessons learnt within and across the franchises. /li liProvides input to the relevant Objectives, Goals, Strategies and Measures (OGSMs), and ensures that clinical trials are executed according to the CDPs and those OGSMs, following the argenx procedures and processes and conducted in compliance with ICH-GCP and other applicable legislation. /li liAs needed, participates in the Clinical Research Organization (CRO) and vendor selection and management process. Supports CDTs and Clinical Trial Teams (CTTs) with issue resolution where required in collaboration with the CODL and alliance vendor manager, if relevant. /li liActs as a point of escalation for resolution of trial management and operational issues within the franchise indications. /li liReviews and provides input to the overarching clinical program/indication documents such as Investigator Brochure (IB), Pediatric Investigation Plan (PIP), FDA/PMDA/EMA and other regulatory critical documents. /li liOversees the Indication and clinical trial budgets and timelines in collaboration with the CODLs and the Clinical Trial Managers (CTMs). /li liOversees the resource requirements for Trial Operations within the franchise and ensures the needed resources are onboarded timely and efficiently. /li liOversees audit/inspection readiness of the assigned program/trials. Support audits and inspections. /li liSupports continuous improvement processes and consistency. Collaborates with the knowledge hubs with the Trial Ops team. /li liAs seasoned Leader, sets expectations, communicates in a transparent, clear way and energizes and motivates the CODLs and the CTMs to work towards achieving the clinical goals in line with the OGSM and argenx’s cultural pillars. /li liAct as line manager for the CODLs and leader within the Trial Ops team: ul liInterviewing candidates /li liOn-boarding /li liEnsuring that assigned staff are trained /li liGoal setting and review /li liMentoring and enabling the growth and development of assigned staff /li liSupports TrailOps and Global Company initiatives as applicable. /li liCollaborate on the franchise level with stakeholders outside of Clinical and RD, eg Corporate Development, Science, Patient Advocacy Group (PAG), Medical Affairs and others. /li /ul /li /ul h3Skills And Competencies /h3 ul liThe Franchise CODL excels in leadership and establishing good and effective internal and external working relationships and communication, embedding the argenx values. /li liProven track record in relevant leadership positions, including line management, within Clinical Operations in the pharmaceutical/biotech industries. /li liProven knowledge of planning and execution of clinical development plans and clinical trials. /li liExperience in building and leading a team with a variety of skill sets. /li liBuild bridges between people, functions and regions. /li liPro-active problem solver - demonstrated ability to identify and resolve issues, identify and mitigate risks, able to handle conflicts. /li liStrong organizational skills, able to 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. /li liExcellent written and verbal communication skills, acting globally in a culturally diverse dynamic team. /li liStrong verbal and written English communication skills (primary fluency or full professional proficiency). /li liThorough knowledge of ICH GCP guidelines and other applicable regulatory requirements and guidelines. /li /ul h3EDUCATION, EXPERIENCE And QUALIFICATIONS /h3 ul liBachelor’s degree or University degree – medical or para-medical (Biology, Biomedical Sciences, Pharmacy, Veterinary etc.) or equivalent by experience. PhD degree is a plus. /li liMinimum of 15 years of leading experience in Clinical Development (monitoring, local and global/international trial management). /li liExperience in working in an outsourced model, including overseeing CROs and vendors. /li liStrategy as well as execution for clinical development. /li liChange and risk management. /li liBudget financial acumen. /li liRare disease and/or auto-immune clinical trial background relevant to the franchise. /li /ul pFor applicants in the United States: The annual base salary hiring range for this position is $268,000.00 - $368,500.00 USD. This range reflects our good faith estimate at the time of posting. Individual compensation is determined using objective, inclusive, and job-related criteria such as relevant experience, skills, demonstrated competencies and internal equity. This means actual pay may differ from the posted range when justified by these factors. Because market conditions evolve, pay ranges are reviewed regularly and may be adjusted to remain aligned with external benchmarks. Note: If the posted hiring range does not apply to your work location, 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. /p pThis job is eligible to participate in our short-term and long-term incentive programs, subject to the terms and conditions of those plans and applicable policies. It also includes a comprehensive benefits package, including but not limited to retirement savings plans, health benefits and other benefits subject to the terms of the applicable plans and program guidelines. /p pAt 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. /p /p #J-18808-Ljbffr