Regional Clinical Operations Lead
Ipsen Bioscience, Inc.
Regional Clinical Operations Lead
Summary / purpose of the position
Global Medical Affairs sponsored and supported programs within North and South America regions
- To provide clinical research and operational expertise/guidance into the design, implementation, execution, follow-up and close out/reporting for GMA led studies and programs including local/ Regional Company Sponsor Studies (CSS), Interventional and Non-Interventional Studies (NIS), Early Access Programs (EAP) and Patient Support Program (PSP),
- Provide clinical research and operational expertise/guidance to Regional/Local clinical operations teams under assigned local/regional scope of responsibility.
- Review Investigator Sponsored Studies / CSS/Program proposals within relevant tools and systems, and attend MARB to support the Medical Advisor/MSL
- Accountable for delivery of all GMA studies/programs within local/regional scope of responsibility and ensure each is delivered within strategic and operational objectives and achieve key performance deliverables ( e.g., quality, operational performance, risk management and approved budgets).
- Input into and oversight of budgets, operational planning, appropriate internal and external resourcing/capacity management, including vendor selection. Ensure business continuity when resource turnover occurs within scope of local/regional assigned territory. This includes stepping in to run the study/program as needed.
- Serve as key point of contact and representative for all Regional /Local GMA clinical related activities vis-à-vis the GMA TA Medical Directors, Medical Asset Lead, Finance, Legal, Procurement, drug safety, QA, cross-functional taskforces, etc.
- Contribute/drive changes in GMA specific processes for continuous improvement and adaptation to business model changes. Contribute to Ipsen quality documents through participation in routine QD life-cycle reviews within both R&D and GMA specific QMS.
- Support Head of GMA ClinOps in cross-functional initiatives within the Region/Country and/or at global level as requested.
Main responsibilities / job expectations
Resource/Capacity Planning, Training and Skills assessments:
- Assess the capacity and resources needs required within the relevant locations to enable the execution of assigned GMA programs at local/regional level. Where requested by Head of GMA ClinOps, support recruitment needs
- Oversee/direct and or drive, as needed, vendor selection in accordance with Ipsen procurement and financial control requirements and ensure appropriate vendor oversight and relationship management at study/program levels and escalation of critical vendor performance issues within compliance of the Vendor Oversight and Governance framework.
- Assess skills and capabilities of medical affairs operational teams within assigned area of responsibility and recommend / support appropriate training and, where applicable, certification.
GMA Sponsored Studies/Programs:
- Provide expertise in GCP or RWE data generation regulations, or in specific therapeutic areas, to assess the operational pertinence of considered clinical study design.
- Review protocol / program plan and input into design and strategy, as needed, to ensure achievement of clinical and data generation excellence
- Review, and input into operational feasibility to ensure execution, timelines, resourcing, and budget assessments are appropriate to meet study/program objectives
- Review and input into local/ regional proposals/documentation to be submitted to Medical Affairs Review Board (MARB) to ensure all criteria are met and support/guide teams on actions/recommendations made by the MARB such that studies/programs are not initiated without having adequately addressed MARB feedback.
- Provide guidance into study/program start up, execution closing and reporting and ensure study plan, budget and deliverables are delivered on time and within expected quality and key performance metrics.
- To lead all operational activities associated with the implementation of approved clinical studies/ programs under local/regional medical affairs scope
- Ensure protocol/ program plan deviations and Quality Events are properly reported, followed and managed according to the Ipsen procedures
- Liaise regularly between Local and Regional clinical operational teams and Regional/Local Patient Safety Managers, and Quality Assurance teams, to ensure appropriate oversight and risk management/remediation on any safety and/or quality deficiencies within studies/programs
- Accountable for support / guidance and direction to region/Country medical affairs teams on inspection-readiness needs. Monitor compliance across teams (under scope of responsibility) to ensure completion of all required trainings/ certifications, all eTMF and study files are complete, maintained in real-time, filed and/or archived according to required procedures.
Referent & Contact points
- Serve as a proactive key point of contact and representative for all Regional /Local GMA clinical related activities vis-à-vis the GMA TA Medical Directors, Medical Asset Lead, Finance, Legal, Procurement, drug safety, QA, cross-functional taskforces, etc.
- Develop and maintain, for operational oversight and reporting purposes, a dashboard (e.g., Score Cards) to track, reconcile and manage the planning, deliverables and budgets on all clinical studies/programs within area of responsibility. Ensure all needed information is shared with key internal stakeholders (e.g., Head of GMA Clinical Operations, Medical TA Heads, Medical Asset Leads, R&D Quality, GPS, Finance, …)
- Present study/program progress at all Quarterly Medical Asset Oversight meetings and escalate any foreseen critical issues and risk mitigation plans
- Perform any other activity as may reasonably be required by the Head of GMA Clinical Operations from time to time that may include serving as hands-on activities to manage a GMA Study, NIS, other program in times of need.
Service Providers (SP) :
- Support the bid defense and selection of the Service Providers ( vendors/CRO etc) in collaboration with Procurement teams (Globally, Regionally and locally), ensuring selection within the approved vendor list and according to Global/local procurement policies.
- Organize (or participate in) meetings with SPs, and ensure efficiency in meeting planning, conduct, consolidation of key discussions points (e.g. timelines, recruitment, quality, resources, budget issues) across studies under span of local/regional responsibility
- Oversee adequacy of SP assigned resources ensuring fit for purpose and ensure SP are held accountable to defined deliverables, timeline and budget with emphasis on clinical trial/ program executional excellence
- Serve as the primary point of contact for teams with respect to issue escalation with Service Providers.
Knowledge, abilities & experience
Education / Certifications: Minimum advanced degree in scientific field ( e., g MSc, MD, PhD, PharmD) or degree in clinical research with extensive relevant experience in clinical operations / clinical program management
- Significant and relevant experience (minimum of 10 years) in clinical operations with significant and relevant project management experience (minimum of 7 years) in MEDICAL AFFAIRS programs, including but not limited to phase IV interventional / Non-Interventional studies, data generation programs ( e.g., RWE/HEOR), Registries, Patient Support programs …)
- Experience in running /overseeing projects at national and international level
- Experience in pharmaceutical drug development (Ph2, Ph3) including project management of national and international programs a plus
- Extensive experience and know-how (minimum of 5 years) in Oncology, Neuroscience (Rare) or Rare Diseases
- Recent (within past 5 years) demonstrable experience in people management ( both direct reports and within a matrix/cross functional level). Adaptive leadership style
- Extensive track-record of interactions with country Medical Affairs Staff (including MSL) a significant advantage
- Deep knowledge of Good Clinical Practice (GCP) and RWE data regeneration regulations.
- Experience of working with multidisciplinary groups and ability to work within a team/ Asset centric environment,
- Experience of managing and developing relationships with Service Providers within a partnership mindset
- Demonstrable ability to present and influence at all levels
- Demonstrable ability to be an out the box thinker, problem solver within the confines of regulatory/legal boundaries
Fluent English, other languages ( e.g., French, Spanish) a plus
Key Technical Competencies Required
- Excellent organisational and management skills,
- Excellent verbal and written communication skills
- Computer literacy
IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.