Clinical Operations Development Lead
The Clinical Operations Development Lead is responsible for the oversight of the clinical related activities within a specific therapeutic indication for an asset (CODL) or across all indications for an asset (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 ad-hoc member of the Asset Strategy Team (AST), works with the MDL and the Project Manager (PM) to ensure that all relevant information from all functions within the AST and CDT are brought to the table. A CDT kicks off as soon as preparations start for a First in Human (FIH) study (in the case of the first indication for a given compound) or when first clinical related discussions start for a new indication.
To build a strong CDT, the CODL works with the respective functional heads to assign CDT representatives from the involved functional areas. During the start of the clinical related activities for a new asset, the AST meetings and the CDT meetings may be combined.
The Target Product Profile (TPP), created by the AST (with input from the CDT), is used as the basis for the CDP. The CDT is responsible for the clinical development strategy, ensuring creation of the CDP and execution once endorsed by the AST. As co-leader, the CODL drives the execution of the clinical program in collaboration with the CDT members and according to what is in the CDP.
The CODL oversees the clinical trial budgets, contributes to timeline and resource requirements and provides input to the financial CDT planning (created and maintained by the PM working with the Finance business partner). Hereto (s)he provides the PM with the estimates and updates of cost versus budget for key deliverables chosen to be integrated into the overarching Indication and Product plans. Informs the PM in case the timelines or budget deviate from projected. The CODL partners with the PM to review status and impact of change and to discuss with the team, options to resolve issues and mitigate risks and adjust the plans accordingly, which may be subject to governance endorsement.
Likewise, the CODL and PM partner to ensure that risks and mitigations are discussed in the team, reflected in the applicable risk registries, and translated into timely plan adjustment and action.
The CODL and the MDL keep the oversight and are the primary contact person for the CDT and all CDP related activities for a given indication (CODL) or across asset indications (X-indication CODL). These include the trial related activities as well as the clinical development strategy across the lifecycle of a compound, starting with the preparation of the FIH clinical trial throughout registration and post-approval clinical development activities. Hence, after completion of the Clinical Phase III program, CODL and MDL, in close collaboration with the CDT members, continue to be involved in the clinical related activities e.g., through input to different regulatory authorities (e.g., FDA, EMA, PMDA, MHRA).
The CODL and MDL ensure the cross-functional optimization of solutions integrating contributions on complex matters and take accountability for decisions taken, each from their discipline’s perspective.
As subject Matter experts, CODL and MDL contribute to CDT discussions where each member drives the topic of their expertise area. Although CODL and MDL take accountability for the (lack of) consensus, the PM manages disputes in case no consensus is reached. This may include organizing escalation to the AST and/or within the respective functional lines.
The actual trials are conducted within the Clinical Trial teams (CTT) led by the Clinical Trial Managers (CTMs) and the Trial Physicians (TPs).
Dependent on the program (phase and number of clinical trials), the CODL may also act as a CTM for 1 or more selected trials.
The CODL function may include line management of Clinical Trial Manager(s) (CTMs) and/or Clinical Trial Associate(s) (CTAs).
Roles & 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 & Competencies:
- 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 (primary fluency or full professional proficiency).
- Thorough knowledge of ICH GCP guidelines and other applicable regulatory requirements and guidelines.
Education & Experience:
- 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.