Job Description

Title: Head of US Clinical Operations, Global MedicalCompany: Ipsen Biopharmaceuticals Inc.About Ipsen:Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation.Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the companyxe2x80x99s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!For more information, visit us at and follow our latest news on and .:Head of US Clinical Operations, Global MedicalWHAT - Summary & Purpose of the PositionAs an expert and accountable within their allocated country, the Head of US Clinical Operations, Global Medical represents GM Clinical Operations strategically in early planning of all global and local evidence generation activities (the IEGP) and provide oversight of the excellence in execution/delivery of those activities. The Head of US Clinical Operations is accountable represent US Global and Local Medical Clinical Operations, which includes direct leadership and matrix leadership to ensure excellence in execution of all evidence generation activities, acting as a point of contact for US Medical Affairs to facilitate and support collaboration between Global Medical Clinical Operations. This role will lead the US local team directly and partner with the Global Clinical Operations leadership team and functions, to maximize efficiencies and timely, quality execution for all studies. This role is also accountable for applicable vendor oversight activities and building strong collaboration with MSL teams within the US to facilitate enrolment/delivery of global and US evidence generation activities. This role provides guidance and advice to the US teams to ensure overall governance and compliance in execution of evidence generation activities.WHAT - Main Responsibilities & Technical CompetenciesTo work with internal stakeholders globally and locally to ensure timely excellence in execution of all evidence generation activities in the US, including direct line management of team for local studies, and matrix management for global studies.

• To provide clinical and operational expertise/guidance for the design, implementation, execution follow-up and closing for any EG, globally and locally, within US (from early planning & validation to full execution as applicable).
• To provide thought leadership and guidance to internal stakeholders on alignment with IEGP priorities, global and local drivers for excellence in execution
• To provide expertise in GCP or RWE data generation regulations, or in specific therapeutic areas, in order to assess the operational pertinence of considered clinical study design.
• To ensure relationship with sites/KOLs/HCPs are maintained and managed in relation to US Medical Clinical Operations in conjunction with global and local teams, inc. interface with MSLs.
• Collaboration with GMA Clinical Operations Leadership team, and Senior Clinical Project Managers to ensure connectivity and alignment in priorities, delivery, and excellence for Global and local studies in the US.
• To take overall line management responsibility for workload assessment, resource allocation, development, support, review, training, and objective setting & performance assessment of all direct reports
• Point of contact between Medical Leadership Team, US Medical Leadership team, Executive Leadership Team to communicate trail progress, issue escalation.
• Member of both US Medical Affairs Leadership Team and Global Medical Affairs Clinical Operations Leadership Team
• Provide oversight project management support to track and monitor the progress of the US EG activities (for example timelines, budget) to ensure delivery to time, budget, and quality. This will include review of quality and KPI metrics to ensure delivery.
• Serve as point of contact for Global Medical Evidence generation activities in the US, providing point of contact for Global Clinical Project Manager for performance and delivery and to engage with TA Director to ensure excellence in global EG, with appropriate aligned asset expertise.
• Ensure co-monitoring of Global & Local Medical Affairs clinical studies within the US, according to the oversight monitoring plan, ensuring adequate contact with investigator sites, identifying, and solving issues in study progress, in collaboration with other study team members, and following up as required with CROs/CRAs/investigator.
• If applicable to set up regular meeting with National Field Lead and MSL (Medical Science Liaison) at LMA (Local Medical Affairs) who can support Clinical Operations at various steps (site qualification, site recruitment)
• Review and input into US documentation to be submitted to Evidence Generation Review Board (EGRB) to ensure all criteria are met and support/guide teams on actions/recommendations made by the EGRB such that studies/programs are not initiated without having adequately addressed EGRB feedback.
• Accountable for support / guidance and direction to US 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.
• Serve as a proactive key point of contact and representative for all Local GMA clinical related activities vis-xc3xa0-vis the GMA TA Clinical Operations and Medical Directors, Medical Asset Lead, Finance, Legal, Procurement, drug safety, QA, cross-functional taskforces, etc.
• 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.

HOW - Knowledge & ExperienceKnowledge & Experience (essential):

• Significant and relevant experience of pharmaceutical drug development (Ph2, Ph3) including project management of national and international programs OR significant and relevant experience in interventional medical affairs studies, RWE/HEOR, NIS studies, including project management of national and international programs.
• Relevant US experience of pharmaceutical drug development (Ph2, Ph3) including project management of national and international programs OR significant and relevant US experience in RWE/HEOR, NIS studies, including project management of national and international programs.
• Proven track record of delivery of projects to time, budget, and quality.
• Intimate knowledge of Good Clinical Practice (GCP) and non-GCP data regeneration regulations.
• Recent, significant, and successful experience in line-managing people.
• Experience of working with multidisciplinary groups and ability to work within a matrix team environment.
• Experience of managing and developing relationships with Service Providers.
• Excellent organisational and management skills.
• Excellent verbal and written communication skills with the ability to drive change management processes and support team members through transitions.
• Demonstrated ability to shape and guide organizational strategies, influencing key stakeholders and driving strategic initiatives.
• Ability to manage complexity and solve problems effectively.
• Computer literacy.
• Travel xe2x80x93 Travel is to be expected within this role as required.

Knowledge & Experience (preferred):

• Extensive track-record of interactions with country Medical Affairs Staff is a significant plus.

Education / Certifications (essential):

• Bachelorxe2x80x99s life science degree required.

Education / Certifications (preferred):

• Masterxe2x80x99s degree or equivalent is a plus.

Language(s) (essential):

• Excellent oral and written English.

Ipsen Biopharmaceuticals, Inc. is an equal opportunity employer. We recruit, employ, train, compensate, and promote without regard to race, religion, creed, national origin, age, gender, sexual orientation, sexual identity, marital status, military or veteran status, disability, genetic information, or any other category protected by applicable federal, state or local law.Ipsen Biopharmaceuticals, Inc. conducts background screening, reference checks, and drug testing as part of its pre-employment screening process. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned.All Employees are expected to adhere to all company policies and act as a role model for company values.The annual base salary range for this position is $215,000 - $315,000.This job is eligible to participate in our short-term incentives program as well as our long-term incentives program.At Ipsen we are proud to offer a comprehensive employee benefits package, including 401(k) with company contributions, group medical, dental and vision coverage, life and disability insurance, short- and long-term disability insurance, as well as flexible spending accounts. Ipsen also provides parental leave, paid time off, a discretionary winter shutdown, well-being allowance, commuter benefits, and much more.The pay range displayed above is the range of base pay compensation within which Ipsen expects to pay for this role at the time of this posting. Individual compensation within this range depends on a variety of factors, including, but not limited to, prior education and experience, job-related knowledge and demonstrated skills.IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individualxe2x80x99s 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.

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