Senior Director, Head of Clinical Trials Start Up & Feasibility (US/UK)

Senior Director, Clinical Trials Start Up & Feasibility  

• Senior level role accountable for directing and leading the strategic planning, execution, and oversight of the clinical trial feasibility and trial site start-up capabilities with a main focus on oncology.   Directs and controls the activities of the clinical trial feasibility and trial site start-up functional area through multiple levels of management within the department. 

• Leads a team of Site Start Up and Feasibility professionals (Directors, Associate Directors, Managers and Specialists) to provide vision, strategy, leadership, and mentoring to their assigned team.

• S/he must have an expert and comprehensive understanding of global start-up operations in oncology and be an exceptional communicator, regularly presenting strategic insights on country selection and enrollment data at Senior Management Meetings.  Develops and imparts deep knowledge and intelligence of Investigational sites, country intelligence, understanding the clinical landscape, culture, standard of care for patients and epidemiology. 

• S/he must facilitate effective internal and external relationships and will partner with other senior leaders to establish strategic plans and objectives.  Apply Jazz leadership expectations to build and support the CCDO team, driving recruitment, performance management, engagement, and career and personal development of team members. 

• S/he must stay current on the latest industry trends and best practices, applying technology and data innovations to evolve strategy and service. Represents the organization at industry events and meetings, building relationships with key stakeholders and partners.

Feasibility Team

By working cross functionally with our clinical operations, clinical development and regulatory submissions groups, as well as through analysing data from internal and public data sources, this

• individual will provide strategic insights on country selection and enrollment planning for high priority global clinical trials.

• Builds and imparts specialist knowledge, deep understanding and detailed intelligence on the type of trial, therapeutic area, inner workings of a country, key obstacles and regulatory landscape.

• To present the feasibility data to our internal Stakeholders and Senior Management as well as developing mitigation strategies for consideration.

• Manages the complete end to end feasibility process. 

• Gathers external clinical trial metrics and intelligence from vendor partners, databases, data analytics, legacy data and publications – develops machine learning to build predictive insights.

• Working with Director level staff, responsible for the recruitment, training, development and performance management for a team of feasibility specialists.

• Directs and provides strategic insight to feasibility assessments for high priority projects and trials, and new business opportunities to provide high quality, accurate feasibility data and analysis to internal and external teams. 

• Consults on corporate and/or organizational policies and authorizes their implementation.

• Provides direction to managers/ directors in various areas, groups and/or operations. 

• Advises on risks, challenges and mitigation steps. 

• Sought out for expertise and guidance by employees beyond own line of authority.

• Accountable for the successful delivery of global feasibility activities for all clinical programs and will drive cross-functional feasibility operational strategies.

• Makes decisions on functional matters that have a broader impact on the organization. 

• Applies strategic thinking to situations across functional area of expertise. 

• Influences strategy to address internal or external business and regulatory issues

Trial Start Up Group

• Sets the vision, the strategic planning, execution, and oversight of study start-up activities.

• Imparts their deep knowledge and understanding of the start-up of Investigational sites, country intelligence and standard of care for patients and epidemiology in the oncology setting.    

• Devises strategies and objectives in the development of plans for country and site activation. 

• Leads a team of Site Start Up professionals (Directors, Associate Directors, Oversight Managers and Start Up Specialists) to provide vision, strategy, leadership, and mentoring to their assigned team.

• Leads focused SWAT Teams to find pragmatic solutions to accelerating site start-up: ethics submissions, regulatory applications, gathering essential documents for submission, accelerated turn-around of responses, contract negotiations with sites, coordinate vendor set up and green light process. 

• Responsible for leading in the matrix performing start up activity, including the review, and overall management of submissions to regulatory authorities and ethics committees. 

• Accountable for all matters related to study start-up requirements and must be able to communicate issues effectively to the Clinical Trial Manager and Executive Management. 

• Adopting a unique start-up methodology to drive site activations through oversight of all activities, driving delivery and compliance across the assigned regions.   

• Leads day to day project activities in the matrix, by working closely with the Clinical Trial Manager. Clinical Project Specialists (Clinical Operations) and CRAs

• Draws on the pool of Clinical Project Specialists (Clin Ops), CRAs, Clinical Trial Services, Regulatory and Contract experts to execute on the Start Up Plan

• Coordinates all start up activities

• Evaluate performance and solve acute challenges and monitor timelines and progress vs. plan

• Specialist knowledge of start-up requirements & activities in each country and region, country requirements, inner workings of a country/ regulatory landscape. 

• Works collaboratively with functional colleagues to ensure successful completion of study start up, fostering productive working relationships with other collaborators within Regulatory, Legal, Contracts, Clinical Coordination and Clinical Operations

• Reviews program or study specifics to define project scope, timelines, and deliverables from project initiation and maintains/monitors throughout

• Develops start up plan that clarifies study specific tasks, general timelines, and processes related to overall study start up and continued maintenance activities

Required Knowledge, Skills, and Abilities

• The ideal candidate will possess a combination of extensive experience within global start-up and feasibility operations, be an exceptional communicator, strategic thinking, commercial acumen, critical appraisal and with strong scientific skills.

• Strong executive presence and should exhibit an innovation-driven mindset to contribute to the evolution of this high-profile new capability. 

• Specialized experience in Oncology with significant industry experience. 

• Demonstrable business acumen experience

• Senior Leadership experience

• Ability to collaborate with cross-functional teams. 

• Experienced and highly driven individual who has a deep understanding of the oncology space and a strong aspiration to create a notable influence within the pharmaceutical industry.

• Extensive pharmaceutical or related industry experience

• Extensive previous experience of working in a Start-up team, Clinical Trial Specialist, CRA, Clinical Trial Manager or similar having worked on global clinical trials. 

• Experience in project management leadership, with finance, organizational development, consulting, IT, change management or process design are beneficial. 

Required/Preferred Education and Licenses

• Degree (BSc or equivalent)

• Extensive pharmaceutical or related industry experience, with significant industry experience.

• Excellent knowledge of GCP and regulations

• Experience of team management