Clinical Operations Lead

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The Clinical Operations Lead (COL) is the co-chair of the Clinical Team, which is the team responsible for the clinical development strategy.

The COL is overseeing the strategic planning and execution of several clinical trials from phase 1 up to phase 4, and related to a clinical development program of a compound or an indication.

The COL function may include Line Management responsibilities of a team of Clinical Trial Managers (CTMs) and/or Clinical Trial Assistants (CTAs).

Dependent on the program (phase and number of clinical trials) and the Line Management responsibilities, the COL may also act as CTM for 1 or more selected trials (see template Job Description CTM if applicable).

The successful candidate will excel in leadership and establishing good and effective internal and external working relationships and communication.

The COL co-chairs the Clinical Team with the Medical Lead. The Clinical Team is ultimately responsible to define the clinical development strategy supporting the Target Product Profile (TPP) across the lifecycle of a compound, starting with the preparation of the “First-in-Human” (FiH) clinical trial throughout “Registration” and post-approval clinical development activities.

• Lead the cross functional Clinical Team together with the Medical Lead and Co-chair the Clinical Team Meetings. With the Medical Lead, represent as applicable, the Clinical Team at the Indication Project Team Meetings.
• With the Medical Lead, ensure that a Clinical Development Plan (CDP) is in place describing the clinical development strategy, comprising effective where possible innovative trial designs. Ensure the CDP is endorsed by the Project Team and supports the Target Product Profile (TPP).
• Oversee risk identification and risk mitigation strategies for the CDP. Identify risks or deviations from plans and communicate to the Global Head of Trial Operations; and to the responsible Program Leader (PL) Lead and Management as appropriate, proactively provide solutions and oversee implementation.
• Responsible for the oversight of all trial operations related aspects within the assigned therapeutic indication/program according to timelines, budget and quality standards.
• Ensure that a Clinical Trial Protocol Synopsis/Clinical Trial Protocol (CTP) is timely in place. Ensure the CTP is in line with what is outlined in the CDP, including pediatric plans and need for Patient Reported outcome endpoints.
• Review and provide input into trial related materials and trial set up (eg Investigator meetings), as outlined in the applicable SOPs and WIs, and ensuring consistency across the different trials within the assigned indication/program.
• Ensure that Clinical Trials are executed according to the CDP, the trial plans/Objective Goal Strategy Measure (OGSM), following the argenx procedures and processes and conducted in compliance with ICH-GCP and other applicable legislations.
• Oversee the country and site selection in view of timely trial start up, patient recruitment and generation of high quality data.
• Pro-actively oversee the patient recruitment and related KPIs of the assigned trials, collaborate with the CTMs to pro-actively identify ways to prevent recruitment delays and manage other KPIs.
• Identify, in collaboration with the CTM(s), the need to perform co-monitoring visits and act accordingly.
• Act as primary point of escalation for resolution of trial management and operational issues within assigned program.
• Participate in the CRO and vendor selection process and oversee the CROs and other vendors involved in the assigned clinical trials based upon KPIs / metrics and plans. Discuss issues which cannot be resolved by the CTM/CRO PM or which occur across different trials with the CRO counterpart and escalate appropriately.
• Make sure that the Global Head of Trial Operations is always informed in case an identified issue/risk could have an impact on/may also occur in the other therapeutic indications/programs.
• Keep the oversight of the Clinical budget for the assigned indication/program, collaborate with the CTMs and the Clinical Team representatives to make sure the budgets are prepared, reviewed and updated within the forecast timelines as agreed with the PL and finance. Ensure that the trials and assigned clinical activities are executed within the agreed budget. Pro-actively escalate to the PL and if need be to the Development Management Committee (DMC) in case of deviations.
• Review overarching documents such as Investigator Brochure (IB), Pediatric Investigation Plan (PIP), FDA/PMDA/EMA and other authority related documents as outlined in the argenx SOPs and WIs.
• Support 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 (collaborate with the Global Head of Trial Operations to ensure proper communication).
• Set expectations, communicate in a transparent, clear way and motivate team members to work towards achieving the clinical goals in line with the OGSM and our cultural pillars.
• Support the Global Head of Trial Operations in development and implementation of initiatives, systems and processes.
• May include line Management of CTMs and/or CTAs. Full on-boarding of new direct reports.
• Ensure that assigned staff is adequately trained and that training is documented.
• Mentor and enable the growth and development of assigned staff.
• Collaborate with Global Head of Trial Operations for own goal setting and goal review as well as of the direct reports.
• Ensure audit readiness of the assigned program/trials. Support internal audits and inspections by Regulatory Agencies, in collaboration with the CTM if it concerns a specific trial.
  

Desired Skills And Experience

• Global Strategic Drug Development experience.
• Proven experience in a relevant global leadership position in Global Trial Operations in the pharmaceutical/biotech industry.
• Pro-active Problem solver - demonstrated ability to identify and resolve issues, identify and mitigate risks, able to handle conflicts.
• Able to manage multiple and varied tasks and prioritize workload with attention to the holistic/ helicopter view and the detail.
• Natural Leader with the ability to work independently.
• Strong people management skills, leader and team player. Line management experience is a plus.
• Program management and organizational skills.
• Excellent 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.
• 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.
• Auto-immune and/or oncology clinical trial background is a plus.
  

Offer

• A competitive salary package with benefits;
• A work environment in a human-sized, dynamic, rapidly growing biotech company
  

Job Info

• Type: Full time
• Location: Gent, Boston