argenx · 3 hours ago
Clinical Operations Development Lead
United States
Full-time
Remote
Senior Level, Lead/Staff
$212K/yr - $318K/yr
10+ years expargenx is a biotech company focused on transforming immunology and delivering medicines for autoimmune patients. They are seeking a Clinical Operations Development Lead who will oversee clinical activities related to specific therapeutic indications, co-lead the Clinical Development Team, and ensure the execution of the Clinical Development Plan.
BiotechnologyClinical TrialsTherapeutics
Responsibilities
Provides strategic input and is accountable for all clinical related aspects within the assigned therapeutic indication/program and in line with the agreed timelines, budget and quality standards and as outlined in the applicable Standard Operation Procedures (SOPs) and Work Instructions (WIs)
Creates the CDP in collaboration with the MDL, PM and other CDT representatives, ensures the CDP describes the clinical development strategy, comprising effective and where possible innovative trial designs and is consistent with the TPP. Ensures the CDP is endorsed by the AST and the Development Management Committee (DMC) and is executed within agreed timelines and budget
Together with the MDL acts as primary point of contact for all clinical related activities for a given indication (CODL) or across asset indications (X-indication CODL)
With the MDL, leads the CDT meetings, hereby supported by the PM who ensures an agenda is in place prior to the meeting, chairs during the meeting, makes sure outcome/actions/conclusions are agreed upon (where the CODL and MDL can focus on the (strategic) content of the discussions) and minutes are in place
Provides input to the Objectives, Goals, Strategies and Measures (OGSM), and ensures that clinical trials are executed according to the CDP and those OGSMs, following the argenx procedures and processes and conducted in compliance with ICH-GCP and other applicable legislation
In collaboration with the other CDT members, identifies risks of missing team goals, timelines or spend expectations, ensures that these are reflected in applicable risk registries and drives their mitigation. Works with the PM to decide which risks and issues are to be put under the attention of the asset Project Leader (PL) and the DMC. Pro-actively provides solutions and oversees implementation and follow-up
Ensures consistency and efficiency in trial set-up and conduct across the different trials within the specific indication(s)
Drives the timely production of a qualitative Clinical Trial Concept Sheet
Collaborates with the CTMs and their respective 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)
Prior to the start of the feasibility for a given study, collaborates with the Countries and Sites Selection Commission (CSSC) to have the initial list in place for possible countries and sites. Gets input from the CTT, AST, CDT and argenx regional teams on the initial list. Oversees the country and site selection and ensures that the AST and CDT are kept informed on the final selection
Participates in the Clinical Research Organization (CRO) and vendor selection and management process. Supports CTT with issue resolution where required in collaboration with alliance vendor manager if relevant
Acts as primary point of escalation for resolution of trial management and operational issues within assigned indication(s)
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. In case of a compound specific impact, involve the X-indication CODL, AST and PM as needed
Reviews 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
Oversees the clinical trial budgets, contributes to timeline and resource requirements and informs the PM in case the timelines or budget deviate from projected
Reviews the program dashboards and provides input to the PM to ensure accurate status updates on key milestones achieved, issues/risks and financial status
Ensures audit/inspection readiness of the assigned program/trials. Support audits and inspections
Supports 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 compounds in collaboration with the X-indication CODL, if applicable, and the Global Head of Trial Operations
As a Leader, sets expectations, communicates in a transparent, clear way and energizes and motivates the CDT team members as well as the respective CTMs to work towards achieving the clinical goals in line with the OGSM and argenx’ cultural pillars
If applicable, acts as line manager of CTMs and/or CTAs:
Interviewing candidates
On-boarding of new direct reports
Ensuring that assigned staff are trained
Goal setting and review
Mentoring and enabling the growth and development of assigned staff
Supports ClinOps and Global Company initiatives as applicable
Qualification
Required
Bachelor's degree or University degree – medical or para-medical (Biology, Biomedical Sciences, Pharmacy, Veterinary etc.) or equivalent by experience
Minimum of 10 years of leading experience in Clinical Development (monitoring, local and global/international trial management)
Experience in working in an outsourced model, including overseeing CROs and vendors
Thorough knowledge of ICH GCP guidelines and other applicable regulatory requirements and guidelines
Strong interpersonal and stakeholder management Skills
Proven Clinical Operations experience in a relevant global leadership position in the pharmaceutical/biotech industry
Pro-active problem solver - demonstrated ability to identify and resolve issues, identify and mitigate risks, able to handle conflicts
Strong 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
Strong people management skills, leadership skills and team player
Excellent written and verbal communication skills, acting globally in a culturally diverse dynamic team
Strong verbal and written English communication skills (primary fluency or full professional proficiency)
Preferred
PhD degree is a plus
Line management experience is a plus
Rare disease and/or auto-immune clinical trial background is a plus
Benefits
Short-term and long-term incentive programs
Retirement savings plans
Health benefits
Comprehensive benefits package
Company
argenx
argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer.
1001-5000 employees
H1B Sponsorship
argenx has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2023 (5)
2022 (4)
2021 (3)
Funding
Current Stage
Public CompanyTotal Funding
$3.75BKey Investors
Forbion Capital Partners
2023-07-18Post Ipo Equity· $1.1B
2022-03-23Post Ipo Equity· $700M
2021-02-02Post Ipo Equity· $999.38M
Leadership Team
Karen Massey
Chief Operating Officer
Carine Rivet-Thions
Associate Director Regulatory Affairs Labeling
Recent News
2026-01-02
2025-12-30
Pharma Letter
2025-12-19
Company data provided by crunchbase