A career is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
Leveraging clinical and operational data is paramount to enable the clinical development organization to make informed decisions and increase the probabilities of operational success. This data will further support improved accuracy on timelines and costs, and improved quality. Additionally, translating the business needs into solutions enabling the organization to be more effective and efficient. This is the strategic mission of the Operational Design Center.
As part of Global Clinical Operations, you will provide leadership to the Operational Design Center organization provisioning resources. Key responsibilities include:
- Accurate and robust assessment of program and protocol feasibility
- Robust clinical trial feasibility including streamlined site/country selection processes with proper internal communications to stakeholders of country/site selection outcomes
- Feasibility and study planning data to key decision-making clinical program / trial governance meetings
- Portfolio level recruitment strategies and associated implementation plans to proactively estimate the impact of patient recruitment programs on trial enrollment while demonstrating balanced ROI for patient recruitment
- High-quality start up data to enable on-time start-up and enrollment of clinical studies. This will include leading indicators of study performance to ensure key milestones are achieved and/or proactive mitigation plans are developed and implemented
- Robust Study Start-up and enrollment KPIs to Study Teams and appropriate governance bodies. This will include stewardship of the KPIs to ensure we achieve industry “Best-in-Class” performance
- Partners with clinical development leaders, study teams and CROs to build/enhance systems, processes and work practices that drive rapid, accurate and robust assessments of program and protocol feasibility (country, site), timing of key recruitment milestones, recruitment planning as well as central oversight of Study Start Up performance
- Ensure Operational Design Center teams partners with, and supports site facing roles to successfully deliver country and site level strategies/processes e.g. Strategic site development, country and site selection, study start up planning, site activation and recruitment delivery
- Responsible for providing early feasibility data to study teams leveraging both internal and external data sources and organizational knowledge/expertise
- Accountable for ensuring effective feasibility scenario generation & planning comparing past performance data and proposed scenarios from CROs
- Accountable for setting the patient recruitment strategy for the company’s portfolio, including the establishment of governance / oversight to ensure patient recruitment programs deliver to timeline and costs, providing knowledgeable insights, as needed, of patient recruitment strategies and tactics
- Develop people, including recruitment, retention, career development and performance management; ensure staff are adequately trained and have the resources to perform their jobs
- Holds responsibility for delivery of Operational Design Center goals and objectives against an agreed set of KPIs
- Influences the creation and alignment of business strategies that promote the widespread implementation of suitable clinical trial technologies supporting study optimization
- Promotes a continuous improvement culture to streamline appropriate processes for maximum efficiency and productivity.
- Actively monitor industry trends and efficiently evaluate and determine their impact to the company.
- Ability to present complex ideas/concepts in a simple fashion
- Ensures accurate resource forecasting, budget management and delivers cost savings as required
- Responsible for the management of indirect departmental budget.
- Manage external budget used for acquiring data and using analysis tools within the Operational Design Center. Conduct return on investment calculations.
- Manage spending on an ongoing basis, working within budget
- Manage delivery to financial budgets, timelines and quality
- Management of people
- Provide functional excellence to own team as well as to colleagues across the organization
- Coach and mentor members of their organization
- Carry out objective setting, performance appraisals and salary reviews, compensation of direct reports and review performance appraisals done by direct reports for other staff within the department and results of the team
- Lead with confidence and inspire; develop individuals within team
- Ability to lead cross-functional, interdisciplinary global teams and achieving work through resources outside of direct control
- Defines team organization, roles and responsibilities, as well as budget.
Who You Are:
- Bachelor’s degree in Life Sciences (e.g., Biology, Chemistry, Pharmaceutical, Mathematics or similar) required; Advanced Degree strongly preferred.
- At least 10 years of experience in drug development in pharmaceutical industry or CROs with advanced degree, 15+ years with Bachelor’s degree.
- Exceptional interpersonal skills, including ability to persuade, negotiate, and moderate conflict
- History of success in a customer facing role with demonstration of meeting customer expectations.
- Excellent project management skills
- Extensive knowledge of relevant applications and systems used in pharmaceutical industry
- Extensive experience in clinical operations and informatics solution delivery
- Extensive experience preparing and presenting complex idea and data
- Excellent understanding of the drug development and regulatory framework
- Experience in the creation, tracking, and reporting of metrics and key performance indicators
- Broad knowledge of analytical methodologies
- Demonstrated ability to foster a learning organization.
- Ability to travel domestically and internationally up to 30% of time
What we offer: We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!