Note: The job is a remote job and is open to candidates in USA. argenx is transforming immunology and delivering medicines to help autoimmune patients. They are seeking a Clinical Operations Development Lead to oversee clinical activities for specific therapeutic indications and co-lead the Clinical Development Team.
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
Skills
- 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)
- Global Strategic Drug Development experience and understanding
- 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)
- Thorough knowledge of ICH GCP guidelines and other applicable regulatory requirements and guidelines
- Experience in working in an outsourced model, including overseeing CROs and vendors
- PhD degree is a plus
- Line management experience is a plus
- Rare disease and/or auto-immune clinical trial background is a plus
Benefits
- This 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.
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