ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
ICON ISS is searching for Clinical Operations Development Leads in the US! This is a remote position but is expected to attend global meetings virtually and in-person as needed. Domestic and International travel is required.
The Clinical Operations Development Lead (CODL) is responsible for the oversight of the clinical related activities within (a) specific therapeutic indication(s) (CODL) or across asset indication (X-indication CODL).
Together with the Medical Development Lead (MDL), the CODL co-leads the Clinical Development Team (CDT) and co-owns the Clinical Development Plan (CDP). As co-leader, drives the team forward executing the CDP and brings information from the (indications overarching) Asset Strategy Team (AST) to the CDT.
A CDT kicks off as soon as a compound moves from the preclinical phase into the First In Human (FIH) (in case of the first indication for a given compound) or when the first clinical related discussions start for a new indication.
The CODL works with the respective functional heads to assign CDT representatives from the other functional areas.
Responsibilities:
- In collaboration with other CDT representatives, ensures that a CDP is in place describing the clinical development strategy, comprising effective and where possible innovative trial designs that will answer the questions asked by the Target Project Profile (TPP).
- In collaboration with other representatives, ensures the CDP is endorsed by the AST and the Development Management Committee (DMC), supports the TPP and is executed within agreed timelines and budget.
- In collaboration with the CDT, identifies clinical associated risks and leads their mitigation. Works with the PM to decide which risks and issues are to be escalated to the Project Leader (PL) and the DMC. Pro-actively provides solutions and oversees implementation and follow-up.
- Ensures that, in collaboration with the CDT, indication specific Objectives, Goals, Strategies and Measures (OGSM) are created, using the Asset OGSM as basis.
- Together with the MDL acts as primary point of contact for all clinical development related activities for a given indication (CODL) or across asset indications (X-indication CODL).
- Ensures that Clinical Trials are executed according to the CDP and OGSM, following the sponsor procedures and processes and conducted in compliance with ICH-GCP and other applicable legislation.
- Ensures consistency in trial set-up and conduct across the different trials within the specific indication(s).
- Provide strategic input and be responsible for the oversight of all clinical operations 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).
- Drives the timely production of a qualitative Clinical Trial Protocol Synopsis (CTPS).
- 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 AST and CDT on the initial list. Ensures that the AST and CDT are kept informed on the final selection.
- Oversees the country and site selection for the respective trials, in view of timely trial start-up, patient recruitment, generation of high-quality data.
- Participates in the 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, makes sure to also involve the X-indication CODL.
- Reviews and provides input to the overarching documents such as Investigator Brochure (IB), Pediatric Investigation Plan (PIP), FDA/PMDA/EMA and other authority related documents.
- Ensures regular (at least monthly) status updates concerning timelines and cost are available at agreed level of detail concerning clinical (preparation, execution, and reporting) milestones and newly surfaced risks.
- Supports continuous improvement processes 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.
- 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
Qualifications:
- The CODL excels in leadership and establishing good and effective internal and external working relationships and communication, embedding the argenx values.
- 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 organisational 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.
- Line management experience is a plus.
- Excellent written and verbal communication skills, acting globally in a culturally diverse dynamic team.
- Strong verbal and written English communication skills (English primary fluency or full professional proficiency).
- Thorough knowledge of ICH GCP guidelines and other applicable regulatory requirements and guidelines.
Experience Required:
- Bachelor’s degree or University degree – medical or para-medical (Biology, Biomedical Sciences, Pharmacy, Veterinary etc.) or equivalent by experience. PhD degree is a plus.
- 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.
- Rare disease and/or auto-immune clinical trial background is a plus.
Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
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