Senior Director, Head of Clinical Programs

Ipsen

About The Position

The Senior Director, Clinical Programs provides strategic leadership and oversees global clinical development operations for designated programs and assets within the Therapeutic area. This role involves building strong relationships with internal and external stakeholders, ensuring alignment with senior leaders, and leveraging clinical and regulatory intelligence to drive innovation. The Senior Director is responsible for the overall CRO & Clinical Partnership strategy, leading clinical development aspects of Due Diligence, Integration, and Business Development, and overseeing multiple programs.

Requirements

18+ Years experience in Clinical Operations managing global clinical studies/programs across therapeutic areas.
Skilled at clinical project management across multiple projects in a fast-paced environment, including ability to develop robust study budget.
Intimate knowledge of ICH- Good Clinical Practice (GCP) and other worldwide regulations applicable to the conduct of clinical research.
Thorough knowledge of Food & Drug Administration (FDA) and European Medicines Agency (EMA), and other applicable national regulations.
Experienced in key Clinical Operations principles, concepts, practices, standards, processes, and tools.
Experience in outlining Clinical operations strategy and ensuring effective delivery.
Effectively transitions between strategy and operational execution, with the adaptability to modify plans as required based on changes in priority.
Experience in building high performing teams through talent development and coaching, developing honest relationships, and generating trust by demonstrating consistency between words and actions.
Experienced in working with multidisciplinary groups and ability to work within a globally located cross functional and cross-cultural team environment.
Significant experience in managing and developing relationships with Service Providers used to support execution of clinical research (e.g., Contract Research Organisations (CROs)), as well as in working in a hybrid outsourcing model with strategic providers (FSO/FSP model).
Capable of addressing issue escalation and governance needs between internal and external teams in a partnership manner.
Experience in compiling and overseeing clinical study budgets, including benchmarking study/site costs and financial control criteria related to purchase orders, invoice checking, and milestone deliverables defined in clinical trial agreements and/or CRO service agreements (SOW).
Excellent organisational and time management skills.
Excellent verbal and written communication skills.
Will be presenting at Senior leadership meetings.
Master’s degree in Life Science or other relevant qualifications required.
Fluent in business English required.
Is an effective Team leader.
Strong people skills with the ability to communicate / interact at all levels within the business and with external partners.
Strong diagnostic, analytical and process improvement skills
Organisational strategic awareness and proven ability of developing strategic solutions.
Strong leadership and line management capability and experience
Excellent IT and Microsoft Office skills
Strong attention to detail, excellent and direct communication skills, strong interpersonal skills, and cross-cultural understanding and sensitivity
Managerial capability with strong leadership profile
Ability to see the big picture, while keeping an eye on the detail.
Ability to represent the company in a highly professional manner.
Ability to take initiative with a positive attitude in all circumstances.
Flexible; independent problem solving and self-direction.
Eager and interested in learning and growing.

Nice To Haves

PhD is preferred.
French as a primary or secondary language is a plus.

Responsibilities

Accountable for forecasting/managing resources and for mentoring, developing his/her team members and driving one-team, transparency, accountability, and collaboration behaviors within his/her team and transversally within the organisation.
Recruit, manage, coach, and develop clinical study operations teams across Ipsen’s R&D Global Hubs including but not limited to France, USA, UK, and China
Enable effective integrated ways for team working across each R&D Hub that is harmonized with other TA clinical study operational teams, addressing executional excellence criteria related to the design, conduct and reporting of clinical studies.
Provides operational and strategic drug development expertise and guidance for the design, implementation, timelines, resourcing, and budgetary planning for assigned clinical development studies within the Neurology Therapy Area
Is an active contributing member within the Asset Team, fully engaged and supporting the Asset Lead/Medical Development Lead and other Asset team members in the creation and seamless execution of the clinical program/study deliverables, either directly or by assigning clinical Operation team members within the asset team
Ensure efficient operational leadership of assigned clinical study programs (planning, implementation, monitoring/controlling, budget, quality, communication, risk assessment, stakeholders’ management, procurement etc.) and full compliance with ICH-GCP, FDA and other country regulations (including EMEA and China), and company Directives that relate to clinical research.
Accountable for Ensure his/her assigned clinical operation teams propose the right clinical operations strategy, costs & timelines at governance meetings.
Enable effective collaboration between Global Project Management and clinical study operations teams and other key members of a product / asset team such as clinical supplies, data management, statistical and medical writing teams (whether in-house staff or via a CRO)
Is accountable for the clinical program budget/forecast and ensure that an optimized study budget is developed, in place, approved and monitored according to defined financial control processes.
Ensure engagement of Service Providers in compliance with company defined outsourcing model, policy and procedure and enable effective Service Provider oversight and governance on each study under his/her responsibility.
Ensure study team subject matter expertise contribution into R&D global operational processes (Polices, SOPS and associated documents) that underpin the overall Quality Management System, ICH-GCP, regulatory and business process needs for executional excellence.
Provide support with scientific, clinical operations input into Business Development/ Due Diligence teams reviewing potential Neurology and Rare Disease assets within their Therapeutic Area.
Support and ensure effective implementation of integration and business continuity for acquisitions within the Therapeutic area (as per defined Integration Plan)
Contribute to cross-functional working groups focused on delivering clinical trial excellence.
Comply with applicable EHS regulations and procedures.
Participate in the site’s EHS performance by reporting risks, malfunctions, or improvements.
Participate in mandatory EHS training.