Senior Director, Head of Clinical Programs

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 companys success. Join us on our journey towards sustainable growth creating real impact on patients and society!

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Job Title:

Senior Director Clinical Programs

Division / Function:

R&D / Clinical / Clinical Development Operations

Location:

UK (London) France (Paris) USA (Cambridge)

WHAT - Summary & Purpose of 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.

WHAT - Main Responsibilities & Technical Competencies

Team management 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 Ipsens 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.

Clinical Study Program responsibilities:

• 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.

Due Diligence/Integration activities:

• 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)

Operational Excellence initiatives:

• Contribute to cross-functional working groups focused on delivering clinical trial excellence.

EHS responsibilities:

• Comply with applicable EHS regulations and procedures.
• Participate in the sites EHS performance by reporting risks malfunctions or improvements.
• Participate in mandatory EHS training.

Key Technical Requirements:

• 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.

HOW - Behavioural Competencies Required

Competency Behavioural Markers

Explanation of Choice

Develops / Coaches Talent

Able to identify and align career goals and blend organizational objectives into a cohesive development plan for self and team
Able to coach
Provides structured actionable regular and directional feedback and acts as a coach to empower people to own their own growth/development
Prepares their own succession plans
Displays a radically humancentered mindset; puts people first; focuses on doing good
Demonstrates ability to build team effectiveness

The role has major leadership scope including line managing global teams (France USA UK China) recruiting developing talent and embedding oneteam and transparency behaviours. This competency directly supports the need for strong people leadership and capability building across global hubs.

Excellence in Execution

Approaches priority setting and setting the stage through the lens of execution
Establishes clarity about the goals accountabilities timelines and next steps; can identify/spot opportunities for real impact on patient and society
Able to be focused and performancedriven with clear KPIs
Plans and aligns effectively (steps resources timelines etc.)
Displays a commitment to best practice sharing and setting
Promotes single point of accountabilities

The Senior Director must oversee operational delivery of clinical programs ensuring timelines quality regulatory compliance financial oversight and risk management are all executed flawlessly. Highstakes clinical development requires strong executional excellence.

Collaborates

Collaborates and communicates without boundaries continuously removes organizational barriers
Focuses on continuous improvement; integrates and leverages key learnings showcases resourcefulness learning/experimenting at scale demonstrates strong entrepreneurial behaviours and mindset

The role requires crossfunctional alignment with Asset Leads Medical Development Leads Global Project Management clinical supplies data management biostats medical writing CRO partners and BD/Due Diligence teams. Collaboration is central to program success in a matrix environment.

Communicates Effectively

Asks open questions and digs deeper; shows care and respect for different perspectives (both verbally and nonverbally) and able to relate to other points of view
Communicates transparently tells it how it is while keeping the communication respectful
Builds clear and crisp messages with structure and focus uses visual communication and storytelling to make the message easy to digest and connect with the outcomes
Demonstrates gravitas

The role interfaces with senior leaders global teams CRO partners regulatory stakeholders and business development functions. Clear concise and influential communication is essential for securing alignment presenting strategies overseeing partners and providing leadership.

Ensures Accountability

Ensures single accountable referents per task/project/outcome (independent of organizational context or multiteam projects)
Builds and anchors an environment where people have the skills and habits to ask for clarification when accountabilities are unclear
Consults/seeks relevant stakeholder views/expertise and coaches/ensures decisions are made by consent vs. consensus
Takes personal accountability for decisions actions successes and failures and fosters the same for others
Follows through on commitment and makes sure others do the same

The Senior Director must own program delivery budget quality compliance and CRO oversight. The role also requires ensuring teams propose the right strategies and timelines at governance forums. Clear ownership and accountability are essential to execute clinical programs efficiently and compliantly.

HOW - Knowledge & Experience

Knowledge & Experience (essential):

• 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.

Education / Certifications (essential):

• Masters degree in Life Science or other relevant qualifications required.

Education / Certifications (preferred):

• PhD is preferred.

Language(s) (essential):

• Fluent in business English required.

Language(s) (preferred):

• French as a primary or secondary language is a plus.