Head of Feasibility and Planning

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:

Head of Feasibility and Study Planning

Division / Function:

R&D Clinical Development Operations (CDO)

Ipsen Job Profile:

Clinical trials Excellence / Clinical Partnerships

Location:

IPSEN Hubs UK (London) France (Paris) USA (Cambridge MA)

WHAT - Summary & Purpose of the Position

To lead and build Ipsens R&D global feasibility and study planning capability by establishing a predictive data / insight driven end-to-end planning model across the clinical development portfolio. The role is accountable for ensuring that all clinical studies are designed assessed and operationally planned with a high degree of rigor leveraging data analytics insights from ISPEN/FSP staff using up-to-date ways of working e.g. AI-enabled to optimize timelines cost and probability of success.

The Head of Feasibility and Study Planning will partner closely across IPSEN (e.g. Medical DDAAI) to ensure effective and integrated utilisation of Data Analytics with Operational expertise and knowhow. The individual will oversee a hybrid team of internal and FSP resources to deliver robust feasibility assessments data/insight driven site and patient strategies and evidence-based activation enrollment and operational forecasts ensuring Ipsen consistently designs trials that are feasible efficient and aligned with patient and regulatory expectations.

WHAT - Main Responsibilities & Technical Competencies

Leadership & Strategy

• Define and implement Ipsens global feasibility and study planning strategy aligned to the broader R&D and CDO transformation agenda.
• Build and lead a high-performing hybrid team (internal FSP) delivering scalable and repeatable planning execution throughout the lifecycle of the trial.
• Establish governance standards and audit-ready processes for feasibility and planning outputs.
• Partner closely with appropriate groups across IPSEN e.g. R&D/Medical IT: Digital Data Analytics & AI to influence and shape technical solutions that meet R&D business needs.
• Lead and establish a clear IPSEN Process Ways of Working Technology and resourcing to ensure high quality outputs delivered with urgency (speed) in a cost-effective manner.
• Based on IPSEN processes/ways of working ensure creation and ongoing optimization of a measurement framework i.e. performance of Site Activation / Enrolment plans vs. actuals; efficacy of overall feasibility outputs (e.g. customer satisfaction) etc.
• Be a focal point for end-to-end CDO/R&D operational planning; understanding the technology infrastructure and ensuring clear and efficient data flows translating into simple use of applicable systems for IPSEN staff.
• Coordinate and own IPSENs R&D Clinical Trial Footprint in collaboration with the Global Head of Study Site Management and Monitoring.
• Actively support feasibility for Medical Affairs studies where appropriate.

End-to-End Study Planning Accountability

• Oversee delivery of all planning components across the full lifecycle:
  • Study design input and protocol optimization.
  • Feasibility assessment (program country site patient).
  • Site and PI identification strategy.
  • Enrollment and operational forecasting.
  • Integrated operational plans.
• Ensure outputs from each step are integrated into a unified data-driven operating plan for the Clinical Trial.
• Define and oversee adherence to global planning and feasibility methodologies standards and governance to enable the end-to-end process collaborating with the TA Clin Ops Groups (e.g. Clinical Project Managers (CPMs) Clinical Project Directors TA Heads etc.).
• Collaborate and establish tools to perform ongoing monitoring of the Clinical Trial performance; assessing and collaborating with study teams to remediate as needed.
• Have working knowledge of external tools and data sets that may support optimization of IPSENs feasibility processes.
• Share outcomes through the appropriate pathways (e.g. CPM) to ensure alignment of outcomes (e.g. Site Activation and Enrolment Plans) with appropriate stakeholders e.g. Study/Asset Team.

Feasibility & Evidence-Based Decision Making

• Lead development of quantitative feasibility dossiers balancing data-driven insights with expert insights from global and country study team representatives.
• Ensure feasibility assessments incorporate:
  • Disease epidemiology and real-world data.
  • Eligibility criteria modeling.
  • Competitive landscape and enrollment risk analysis.
  • Insights and context from IPSEN and Investigator staff.
  • Differences in Medical Practice across countries.
• Drive the utilization and adoption statistical models (e.g. Monte Carlo Simulations) with scenario planning.

Data Analytics & AI Integration

• Surveille the external environment and drive the use of advanced analytics across planning activities including:
  • Cohort analytics and real-world data (RWD) insights.
  • AI-driven site and patient intelligence.
  • Predictive enrollment and simulation modeling.
• Partner with Data Science / Digital teams to operationalize AI-enabled planning tools.

Study Design & Optimization Support

• Ensure early integration of feasibility insights into protocol design.
• Drive optimization of inclusion/exclusion criteria endpoint selection and study complexity.
• Promote use of simulation and data-led decision making to reduce protocol amendments.

Country Site & PI Strategy

• Oversee development of data/insight-driven country and site selection models based on:
  • Patient availability performance and regulatory factors/timelines.
  • Site capability and diversity considerations.
  • Ensure robust PI identification strategies leveraging real-world evidence and historical performance data.
  • Obtain up-to date insights on evolving landscapes to augment data (e.g. evolving Regulatory requirements Site/Investigator performance etc.).
  • Availability and access to approved Medical Treatments in the disease areas of interest.

Enrollment & Operational Forecasting

• Lead development of Site Activation and Enrollment forecasts using simulation models.
• Ensure incorporation of key risk drivers (screen failure dropout competition) into planning.
• Translate forecasts into operational strategies (site activation monitoring supply) in conjunction with CPM/CPD to support onward activities e.g. Asset Team review.
• Define the service and oversee of planning support to applicable roles e.g. CPM to ensure high quality maintenance of appliable IT systems e.g. OnePlan.
  • Ensure simplistic data flow between applicable systems e.g. OnePlan CTMS Site Activation/Enrolment modeling tools.
• Partner to create applicable clinical trial monitoring tools e.g. Statistical Models / AI to predict likelihood of reaching LPI/other milestones to plan.

Continuous Improvement & Knowledge Management

• Build and maintain a centralized planning knowledge base capturing lessons learned across trials.
• Ensure planning outputs are reusable and continuously improve future study design.
• Drive a continuous planning loop mindset across the organization; defining KPIs to measure effectiveness of the process.

HOW - Behavioural Competencies Required

Competency

Description

Competency Behavioural Markers

Drive Vision and Strategy

Seeing ahead to future possibilities and translating them into breakthrough strategies.

Painting a compelling picture of the vision and strategy that motivates others to action.

• Paints a compelling picture of the vision (future status quo) and strategy that motivates otherstoaction.

Business Insights

Applying knowledge of business and the

marketplace to advance the organizations goals

• Makes decisions based on data facts and figures and considers different perspectives and the patients voice;
• Able to translate toobjectivesandsettingthe bar.

Manage Complexity

Making sense of complex high quantity and

sometimes contradictory information to

effectively solve problems.

• Identifiescontradictory information/demands/inputs to effectively solve problems;
• Develops and evaluates alternativescenarioand solutions;
• Able toidentifywhat truly matters and prioritize decisions with real impact.

Collaborates

Building partnerships and working collaboratively with others to meet shared objectives.

• Collaborates and communicates without boundaries continuously removes organizational barriers;
• Focuses on continuous improvement and learning at scale.

Excellence in execution

Planning and prioritizing work to meet commitments aligned with organizational goals. Consistently achieving results even under tough circumstances.

• Approaches priority setting through the lens of execution;
• Establishesclarity on goalstimelinesand accountabilities;
• Performance-driven with clear KPIs;
• Plans and aligns effectively;
• Promotes best practice sharing;
• Promotes accountability.

HOW - Knowledge & Experience

Knowledge & Experience (essential):

• 10-15 years experience in clinical trial feasibility study design and planning methodologies within global programs.
• 8 years of experience in defining global strategy and driving global transformation.
• Proven experience leading data-driven clinical operations transformation initiatives.
• Demonstrated experience collaborating with Country Operations teams of different sizes and operational models across all trial types.
• Demonstrated experience of people/project management experience (e.g. leading project teams operational teams cross functional teams through operational change and transformation).
• Extensive experience in clinical development clinical operations quality compliance or related areas in the pharmaceutical or biotech industry.
• Demonstrated understanding of the clinical trial landscape and commitment to innovation creativity and operational excellence.
• Strong knowledge of:
  • Real-world data and analytics applications in clinical development.
  • Enrolment forecasting and simulation methodologies.
  • Site selection and feasibility best practices.
• Process and metric creation and optimisation.
• Experience managing hybrid delivery models (internal FSP/CRO partners).
• Demonstrated ability to operate at global cross-functional leadership level.
• Proven influencer and change agent with superior project management capabilities. Project management excellence in planning prioritisation problem solving and organisational skills. Used to managing multiple priorities in a dynamic environment. Agile mind-set.
• Experience in managing internal stakeholders and used to communicating across all levels of the organization including up to ELT level.
• Strong understanding of clinical systems (eTMF CTMS QMS etc.) and business process design.
• Effective leadership skills and proven ability to foster team productivity and cohesiveness in changing environment is required.
• Financial acumen is required.

Knowledge & Experience (preferred):

• Experience in Site Management and Monitoring optimal.
• Experience implementing AI/ML-driven planning or feasibility tools.
• Background in oncology and/or rare disease clinical development.
• Experience with CTMS/data platforms and integrated data environments.

Education / Certifications (essential):

• A minimum of a bachelors degree (University/college degree) in a scientific discipline or general management is required.

Education / Certifications (preferred):

• Advanced degree (e.g. Masters MBA MD PhD Pharm D) is preferred.

Language(s) (essential):

• English

Language(s) (preferred):

• N/A