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About the Role
The Business Process Lead is a senior individual accountable for the end-to-end management of Clinical Development business processes, ensuring quality, efficiency, and optimization of clinical operations outcomes.
Responsibilities
- Define Clinical Development Process Objectives and Management, aligning process vision with R&D strategies.
- Set Targets by embedding agreed Key Performance Indicators in the CDO framework and processes.
- Design and maintain the process Framework for managing processes within the CDO organization.
- Support evaluation and selection of systems for Clinical Operations functions, ensuring integration of systems and processes.
- Develop and maintain policies, procedures, and controls governing CDO processes.
- Validate team member adherence to policies and define corrective actions.
- Identify potential roadblocks, conflicts, and risks within the process and implement mitigating measures.
- Continuously monitor and report KPI scorecards on process performance to CDO Leadership and Asset Teams.
- Analyze data to ensure processes yield expected quality and return on investment.
- Champion continuous improvement to eliminate inefficiencies and optimize processes.
- Define process changes to mature Clinical Development processes and improve their overall health.
- Conduct external environment scanning for new ways to optimize processes.
- Support review of training material for new systems and processes.
- Synchronize process goals across Clinical Development and cross-functional lines to prevent siloed work.
- Act as the escalation point and single point of contact for major process-related issues or improvement suggestions.
Requirements
- A minimum of 8 years of previous Pharmaceutical Industry experience is required.
- At least 5 years of GXP experience within clinical research.
- Well-developed skills and knowledge of clinical operations business processes and practices (i.e., SOPs governing clinical research activities).
- A minimum of 4 years experience in development, management, and leadership of Clinical Operations Business Process.
- Demonstrated ability to deliver a culture of continuous improvement.
- Planning and tracking skills, with the ability to see the big picture, be well organized, results-focused, customer-focused, capable of managing multiple projects, and possess excellent time management.
- Knowledge of the overall drug development process.
- Experience across all Clinical Trial Phases 1-4 is preferred.
- Experience in quality assurance activities, including audits of clinical investigative sites, systems and vendors, and audits of regulatory submissions is an asset.
- Ability to influence and motivate professional colleagues and stakeholders.
- Proven conflict resolution/management and negotiation skills.
- Ability to independently plan, organize, coordinate, manage and execute assigned tasks.
- Demonstrated clarity of communication.
- Demonstrated ability to influence key internal and external stakeholders.
- Experience of the key customers’ business processes and practices.
- Demonstrated ability to engage with authorities, trade associations and key clinical trial sites.
Skills
- Excellence in Execution
- Ensures Accountability
- Communicates Effectively
- Taking a stand (courage)
- Planning and prioritizing work
- Consistently achieving results
- Performance-driven with clear KPIs
- Planning and aligning effectively
- Best practice sharing and setting
- Single point of accountabilities
- Building environment where people ask for clarification
- Consulting/seeking stakeholder views
- Making decisions by consent
- Taking personal accountability
- Following through on commitment
- Developing and delivering communications
- Asking open questions
- Communicating transparently
- Building clear and crisp messages
- Stepping up to address difficult issues
- Saying what needs to be said
- Challenging the status-quo
- Being decisive
- Doing what is right
- Quality driven
- Facing fears
- Stepping out of comfort zone
Location
- U.S.
- France
- U.K.
Work Type
- Hybrid
Experience Level
- Minimum of 8 years of previous Pharmaceutical Industry experience
- At least 5 years of GXP experience within clinical research
- Minimum of 4 years experience in development, management and leadership of Clinical Operations Business Process
Education Level
- Bachelors Degree in life sciences or a professional degree in life sciences (eg Nursing , Pharmacy)
- Project Management Certificate (PMP/PRINCE2 etc.)
About the Company
- 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 company’s success.
- Join us on our journey towards sustainable growth, creating real impact on patients and society!
- For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram.
Equal Opportunity
- We are committed to creating a workplace where everyone feels heard, valued, and supported; where we embrace “The Real Us”.
- The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities.
- When we include diverse ways of thinking, we make more thoughtful decisions and discover more innovative solutions.
- Together we 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.