BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General Description:

Acts as line manager for study start-up and trial monitoring staff (incl CRA line managers as applicable) in UK & Ireland.

Drives the study start-up and trial monitoring team in the UK & Ireland to achieve excellence in study start-up and site monitoring

Partners with both internal (e.g., medical affairs colleagues) as well as external (e.g. clinical sites, Key Opinion Leaders) stakeholders to establish BeiGene as a collaboration partner for clinical trials in the UK

Demonstrates a high level of clinical operations knowledge, organizational skills, project management and leadership competencies

Implements best practices and shares lessons learned with the team and other colleagues as appropriate

Ensures consistency in processes and drives Monitoring Excellence and clinical Operations performance in the UK & Ireland

Adheres to ICH/GCP, local regulations, SOPs and contributes to the development and/or review of Clinical Operations Work Instructions and SOPs

Works to high quality and maintains a positive and results-orientated work environment.

Essential Functions of the Job:

Responsible for building and developing the start-up and trial monitoring team in the UK & Ireland, including the hiring, training, development and resource allocation of BeiGene staff and oversight of FSP staff in the UK & Ireland

Builds partnerships with FSP vendors to allow optimal resource utilization in both study start-up and site monitoring teams in the UK & Ireland

Oversight of study start-up and monitoring in the UK & Ireland to:

achieve timely and complete IRB/EC submissions

ensure TMF completeness prior to handover from Start-Up to the Monitoring team          

ensure successful delivery of country site commitments, i.e., achieving site activation and enrolment goals within planned timelines, as well as maintaining inspection readiness

Performs accompanied visits of CRAs to assess their performance

Builds knowledge of clinical site capabilities in the UK & Ireland to optimize site selection

Establishes effective site relationships with key sites in the UK & Ireland to optimize timelines, recruitment, quality and overall performance

Collaborates with other Clinical Operations functions (e.g., Trial Management) to support the successful planning and execution of clinical trials

Collaborates with other line functions (e.g., Medical Affairs, Commercial, New Markets) to support site relationships and build a strong presence of BeiGene.

Collaborate with other countries to support process improvement, knowledge sharing and teamwork.

Provides ongoing mentoring and training to study start-up and trial monitoring teams and other functional areas as needed on Monitoring Excellence tools and planning

Assists in maintaining and updating company-level investigator database

Leads initiatives and workstreams within Monitoring Excellence, as required

Provides input into SOP development that impact on Monitoring Excellence

Contributes to Clinical Operations strategy and performance against key metrics

Supervisory Responsibilities:  

Ensure the competencies and skills required for study start-up and trial monitoring team in the UK & Ireland are consistent with the company-defined requirements.

Conduct mid-year and year end performance appraisals for direct reports, which include providing constructive feedback as well as oversight of subordinate team’s performance.

Education Required: 

Bachelor’s degree (or equivalent) or higher in a scientific, medical or healthcare discipline

Other Qualifications:  

10 years+ progressive experience in clinical operations, preferably within the biotech/ pharmaceutical sector within the UK & Ireland

Solid leadership and management experience, experience in therapeutic area (oncology) is highly recommended

Ability to work independently and effectively handle multiple priorities in a fast-paced environment

Excellent interpersonal skills, strong organizational skills and effective written and verbal communication skills across all levels within an organization

In-depth understanding of the clinical trial landscape (trial sites, regulation, patient flows) in the UK and Ireland

Travel: up to 10-15%

Computer Skills:   Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook

BeiGene Global Competencies:

When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

Fosters Teamwork

Provides and Solicits Honest and Actionable Feedback

Self-Awareness

Acts Inclusively

Demonstrates Initiative

Entrepreneurial Mindset

Continuous Learning

Embraces Change

Results-Oriented

Analytical Thinking/Data Analysis

Financial Excellence

Communicates with Clarity

BeiGene Global Competencies

When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

Fosters TeamworkProvides and Solicits Honest and Actionable FeedbackSelf-AwarenessActs InclusivelyDemonstrates InitiativeEntrepreneurial MindsetContinuous LearningEmbraces ChangeResults-OrientedAnalytical Thinking/Data AnalysisFinancial ExcellenceCommunicates with Clarity

We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.