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Program Lead - Functional Service Provider Clinical Trials Team

Summarized Purpose
  • The Project Leader reports directly to Argenx Chief Medical Officer.
  • The Project Leader leads the Project Team and ensures that an E2E planning is put in place 
  • The Project Leader oversees all activities E2E within an Indication or multiple Indications as required. 
  • The Project Lead is responsible for the project/program budget and the financial reporting to Financial Management. 
  • The Project Lead reports into the Development Management Committee (DMC), and collaborates with other Project Teams (across indications and compounds, as applicable). 
  • This role corresponds to a Director, with a goal to progress to a Project Management Pillar Head/Therapeutic Area Head ( someone who might have this on their development track and is high performer could gain key experience in this PL role)

Essential Functions
  • PL, in collaboration with the Project Team, ensures a TPP (Target Product Profile) is in place, shared with other Project Teams (across indications and compounds, as applicable) and updated when needed
  • PL, in collaboration with the Project Team, ensures a development strategy (in line with the company strategy and TPP) is proposed to the DMC and translates the approved strategy into an E2E development plan (from preclinical up to label, and post-launch covering activities in support of label updates (Phase I-III studies , potentially phase IV and IIS, …).
  • PL ensures that all Project Team members manage their budgets, actuals and forecasts according to the applicable processes, reviews the input and communicates outcomes to Finance. The PL and Finance fully align before financial reporting to Management.
  • Working with the Project Team, the PL ensures key regulatory documents are delivered (pre-IND, IND, FDA/EMA/PMDA EOP2 BB, BLA/MAA, ODA,…). 
  • PL facilitates and oversees a cross-functional risk assessment and mitigation of the project and manages project risks through a risk register
  • PL drives the Project Team setup, builds a high performing team. The PL clarifies performance expectations to the Project Team members and coaches the Project Team members on their Project Team role. The PL can also be a member of specific project related subteams, as required. 
  • PL aligns with the People Leaders/HR on recruitment and training/development needs of the project team members and is a key stakeholder in performance reviews. 
  • PL, together with Communications and the Project Team, ensures a communication and publication plan is put in place. PLs check the press releases (Indication specifics) before they are sent out and ensures that all other info shared with externals has gone through the necessary approval processes and shared with the needed dedication and keeping the company values in mind. 
  • PL proposes issues to be discussed across Indications to other Project Teams (across indications and compounds, as applicable) and provides all necessary input for discussion, participates to the discussion and ensures debrief to the Project Team. The PL is a point of escalation for the  project team
  • PL, together with the Project Team, identifies the need to organize AdBoards and ensures proper, agenda driven, preparation. The PL attends the AdBoards. 
  • PL ensures a quality dashboard is available at Project level and motivates the Project Team members to execute their activities with high quality, helps find solutions for detected and escalated issues
Policy and Strategy
  • The PL leads, defends and keeps the company strategy in mind at all times, generally operating in an oversight capacity but goes into more detail where needed, is solution focused, pro-active, thinks efficiently, embraces innovation
  • The PL sets expectations, communicates in a transparent, clear way and motivate team members to work towards achieving the clinical goals and CDP
  • PL escalates to and ensures discussion/endorsement of changes, issues and potential solutions with the DMC (change in scope, timelines shift, budget increases, issues in execution of the Project, quality concerns…). The PL ensures topics to be discussed are added to the DMC agenda, ensures the discussion is well prepared with the Project Team, ensures decisions are documented and communicated to/implemented by the Project Team. 

Knowledge, Skills and Abilities 
  • Significant strategic Drug Development, Clinical and Operational experience, in a relevant global leadership position in the CRO/pharma/biotech industry.
  • Strong communicator with proven ability to lead teams without direct line management 
  • Proven track record of leading teams to successful execution of a Program/Portfolio of studies/compounds 
  • Pro-active problem solver capabilities, solution focused, identifies and mitigates risks, able to handle conflict. 
  • Excellent interpersonal skills, a relationship builder.
  • Strong leadership and people management skills, team player. 
  • Effective organizational skills, judgement and decision making skills. Embraces innovation.
  • Effective written and verbal communication skills, acting globally in a culturally-diverse dynamic team.
  • Thorough knowledge of ICH GCP guidelines and other applicable regulatory rules and guidelines.

  • Preferred Advanced degree (Master or PhD) in a health-related discipline or equal with years of experience
  • Minimum 10 years of leadership experience in Clinical / Drug Development. Global Trial experience required.  
Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job.  Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.

Physical Requirements:       
  • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.   
  • Frequent mobility required. 
  • Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
  • Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. 
  • Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
  • Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. 
  • Frequently interacts with others to obtain or relate information to diverse groups.    
  • Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence.  Ability to perform under stress.  Ability to multi-task.   
  • Regular and consistent attendance.

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