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About the Role

The Clinical Program Director (CPD) holds full accountability for global clinical development programs, leading and developing a team of Clinical Project Managers, Clinical Monitoring Leads, and CTAs. This role drives excellence in external stakeholder management and leads clinical partnerships, ensuring timely issue resolution and that Ipsen is viewed as a partner of choice. The CPD is responsible for the clinical development plan and leads all clinical development operations aspects for the assets in scope at the Asset Team level, ensuring cross-functional oversight. They leverage market/industry insights to drive innovation and shape company processes for increased efficiency and collaboration. The CPD may manage 1-2 programs or multiple indications within a program.

Responsibilities

Accountable for forecasting/managing resources and driving one-team, transparency, accountability, and collaboration behaviors within their team and transversally.
Recruits, manages, develops, mentors, and trains Clinical Project Managers, Clinical Monitoring Leads, and Clinical Trial Assistants.
Fosters a culture of collaboration, accountability, continuous improvement, and operational excellence.
Provides clinical and operational expertise and guidance for the design, implementation strategy, resourcing, and budgetary planning for clinical programs.
Works closely with Therapeutic Area Clinical Development Managers, Biostats, and cross-functional team members on programs to outline the Clinical Development Plan and Target Product Profiles.
Accountable for forecasting Clinical Development Operations (CDO) resources (internal/external), timelines, and budgets needed for clinical programs.
Represents clinical operations on the Asset Team and sits on Clinical Development teams.
Accountable and responsible for outlining the clinical operations strategy to deliver on clinical development plans, including CRO selection, country/site selection strategy, and recruitment rates.
Ensures timelines and key deliverables for clinical studies are followed and aligned at the Asset Team level, and with line manager, TA CDO Head, and Head of CDO.
Responsible and accountable for managing relationships with Service Providers (SPs), including issue escalation, timely resolution, and supporting CPMs in SP oversight.
Responsible and accountable for ensuring all clinical studies within the program are delivered on time and within budget.
Provides expertise as a contributing author in the development of clinical documents (e.g., study concept, Investigator Brochures, IND, Briefing documents).
Ensures assigned CPMs provide expert/functional review of study documents (e.g., Protocol, Reporting and Analysing Plan, Clinical Study Reports).
Contributes to advisory boards, expert scientific committees, and submission teams.
Brings industry insights into Ipsen to ensure the organization is built for the future.
Analyzes and recommends solutions to line manager and other Heads of Department within CDO and R&D on organization and participation in effective clinical trial programs.
Drives changes in processes for continuous improvement, training, and adaptation to business model changes.
Ensures all program activities comply with Global SOPs and other documentation in force within the Ipsen Group.
Performs any other activity as may reasonably be required by their line manager.

Requirements

10+ years of Clinical Operations experience in Pharma, Biotech, or CRO managing Ph1-3 global clinical studies/programs in Oncology.
Experience managing pivotal filing studies and global submissions.
Good understanding of the drug development process.
Experience in preparation and review of clinical study documents including Investigator Brochure, Investigational New Drug Applications (IND), study protocols, clinical study reports, applicable sections of New Drug Applications (NDA) and/or Marketing Authorization Application (MAA), and safety reports.
Thorough knowledge of FDA and EMA regulations, ICH guidelines, GCP, and key Clinical Operations principles, concepts, practices, standards, processes, and tools.
Experience in outlining Clinical Operations strategy and ensuring effective delivery.
Organizational strategic awareness and proven ability to develop strategic solutions.
Effectively transitions between strategy and operational execution, with adaptability to modify plans based on priority changes.
Strong diagnostic, analytical, and process improvement skills.
Experience managing and developing relationships with Service Providers (SPs).
Proficient in risk management to prevent and overcome complex safety and compliance issues during clinical program implementation.
Experience preparing and managing clinical study budgets.
Excellent organizational and management skills.
Strong leadership and line management capability and experience.
Effective team leader, experienced in building high-performing teams through talent development and coaching, developing honest relationships, and generating trust.
Excellent communication skills, strong interpersonal skills, and cross-cultural understanding and sensitivity.
Ability to interact at all levels within the business and with external partners.
Ability to represent the company in a highly professional manner.
Experience working with multidisciplinary groups and ability to work within a team environment.
Ability to see the big picture while keeping an eye on the detail.
Ability to take initiative with a positive attitude in all circumstances.
Flexible; independent problem solving and self-direction.
Excellent IT and Microsoft Office skills.

Skills

Clinical development program management
Team leadership and development
Stakeholder management
Clinical trial design and strategy
Budget management
Resource forecasting
CRO management
Risk management
Regulatory compliance (FDA, EMA, ICH, GCP)
Clinical document development
Cross-functional collaboration
Process improvement
Strategic planning
Operational execution
Problem-solving
Communication
Interpersonal skills
IT and Microsoft Office proficiency

Location

Global

Work Type

Hybrid

Experience Level

10+ years of Clinical Operations experience
Experience in managing pivotal filing studies and global submissions
Experience in First-in-human studies in oncology strongly preferred

Education Level

Bachelor’s degree in a relevant life sciences discipline
Advanced degree (Master or PhD level) or equivalent advanced qualification(s) preferred

About the Company

Ipsen is a mid-sized global biopharmaceutical company focused on transformative medicines in 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.
Tackles areas of high unmet medical need through research and innovation.
Passionate teams in more than 40 countries focused on what matters, endeavoring every day to bring medicines to patients in 88 countries.
Builds a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence, and impact.
Empowers every individual to be their true selves, grow, and thrive alongside the company’s success.
Journey towards sustainable growth, creating real impact on patients and society.

Equal Opportunity

Committed to creating a workplace where everyone feels heard, valued, and supported; where we embrace “The Real Us”.
Value different perspectives and experiences drives commitment to inclusion and equal opportunities.
When we include diverse ways of thinking, we make more thoughtful decisions and discover more innovative solutions.
Strive to better understand the communities we serve.
If you require any adjustments or support during the application process, please let the recruitment team know. This information will be handled with care and will not affect the outcome of your application.