BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) is a global, commercial-stage, research-based biotechnology company focused on molecularly-targeted and immuno-oncology cancer therapeutics. With a team of over 2,200 employees in China, the United States (Cambridge, MA; Ridgefield Park, NJ; Emeryville, CA & San Mateo, CA), Switzerland and Australia, BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for the treatment of cancer. BeiGene is working to create combination solutions aimed at having both a meaningful and lasting impact on cancer patients. For more information, please visit www.beigene.com.
The Senior Manager of Clinical and Biometric Systems role is a key leadership position Beigene IT organization. The primary goal of this position is to architect and manage the portfolio of applications and solutions in the Clinical and Biometric functions. This global function will help define business objectives, engineer technical solutions and manage the configuration, installation and implementation of enterprise applications. This individual will be the primary business relationship manager with the global business units. They are also responsible for planning, structuring, and monitoring system implementation, as well as testing and change control procedures for relevant GxP systems. This individual will apply proven communication and problem-solving skills to guide and assist the Biometrics, Clinical teams on issues related to the design, development, and deployment of mission-critical information and software systems in a biopharmaceutical environment.
The ideal candidate should bring experience working in Cloud/SaaS environments with the ability to manage multiple projects across different functions for a global, geographically diverse environment. The candidate should also be experienced at running IT projects as a business from a strategy, technology, security, process, finance, and people management standpoint. The individual must be able to provide technical expertise and have system administration experience. This individual will apply proven communication, analytical, and problem-solving skills to help maximize the benefit of enterprise IT system investments.
Essential Functions of the job:
* Act as technical and/or project lead in the planning, design, configuration, and deployment of new systems, and enhancements to existing enterprise wide computerized systems primarily for the global Clinical, Biometrics, Clinical Informatics teams.
* Collaborate with the project team in the planning, design, configuration, and deployment of new applications, and enhancements to existing applications including SAS, R/RStudio, Spotfire, SFTP, CTMS, EDC, Clinical Data Warehouse and other Clinical systems
* Act as the business relationship manager (BRM) for all Clinical and Biometrics departments
* Design, configure and implement data integration between multiple enterprise systems along with future strategy towards enterprise integration platform
* Collaborate with IT Infrastructure Engineering, Operations, Security/Compliance, QA, Service Desk and applicable vendor team to properly assess project complexity, compliance requirements and technical.
* Evaluate, install, configure, and deploy new applications, systems software, products, and/or enhancements to existing applications throughout the enterprise.
* Collaborate with analysts, designers, and system owners in the testing and validation of new software programs and applications.
* Ensure that any new software integration into company systems meets functional requirements, system compliance, and interface specifications.
* Design, develop, troubleshoot, and install application enhancements and upgrades. Negotiate contracts with software and service providers.
* Define project scope, goals and deliverables that support business goals in collaboration with senior management and stakeholders.
* Manage projects to ensure appropriate resources are allocated and timelines are met
* Manage consultants to ensure projects and/or required system administration activities are addressed adequately.
* Analyze user enhancement requests to deliver solutions focused on establishing and improving business processes, addressing process gaps, and enabling automation and growth of the organization.
* Identify and resolve application incidents and requests or refer to other technology groups or vendor when necessary
* Manage computer system validation documentation workflows as required by 21 CFR Part 11 compliance. Plan and implement application upgrades, maintenance fixes, and vendor-supplied patches
* Partner with Service Desk and IT Operations to develop post-implementation support structure
* Address issues related to application access, connectivity and performance. Test any fixes and perform post-resolution follow-ups to ensure issues have been adequately addressed.
* Provide user training and manage user permissions to applications as needed
* Generate metrics and reports as needed for management review
* 5+ years direct experience managing R&D applications and/or systems management with a focus on Clinical, Quality, Regulatory, and Research systems in a pharmaceutical or medical device industry especially SAS and CTMS .
* Proven experience in overseeing the direction, planning, installation and implementation of software solutions. Direct, hands-on experience with server administration tools.
* 3+ experience in working within GxP or regulated environment and within an SDLC framework.
* Good working knowledge of O365 and active directory technology and schema
* Working knowledge of IaaS (Amazon Web Services, Azure) PaaS and SaaS architectures and technology options a plus
Bachelor's Degree in Information Technology or related field/experiences
This position may include managing staff; coaching and mentoring of junior staff with training/orientation/qualification and development plan when required.
Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically in accordance with BeiGene's Code of Business Conduct and Ethics, policies and procedures.
Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; Completes administrative tasks correctly and on time; Follows instructions and responds to management direction.
Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations; Writes clearly and informatively; Able to read and interpret written information.
Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed; Contributes to building a positive team spirit; Shares expertise with others.
Adaptability - Able to adapt to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.
Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.
Dependability - Follows instructions and responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.
Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.
Project Management - Communicates changes and progress; Completes projects on time and within budget.
* 5+ years direct experience managing enterprise applications and/or systems management
* Proven experience in planning, installation and implementation of software solutions, especially cloud based systems
* Networking and general IT security knowledge
* Excellent project management skills and/or substantial exposure to project-based work structures.
* Direct hands-on experience implementing and GxP computerized systems
* Extensive experience with core software applications, including SAS, R/Rstudio, Spotfire, CTMS, and other Clinical/Biometrics systems.
* 3+ years of experience managing applications teams (either functionally or project based) in the delivery of application solutions
* Excellent written and oral communication skills. Excellent listening and interpersonal skills.
* Strong customer-service orientation.
* Ability to communicate ideas in both technical and user-friendly language.
* Highly self-motivated and directed.
* Ability to effectively prioritize and execute tasks in a high-pressure environment. Experience working in a team-oriented, collaborative environment.
* Strong knowledge of authoring computer system validation documentation
Travel: < 5%
BeiGene Is An Equal Opportunity Employer
BeiGene is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristics protected by law. As a federal contractor, BeiGene has established affirmative action programs to ensure non-discrimination and affirmative action in BeiGene's policies and practices for qualified women, minorities, protected veterans, and individuals with disabilities. The narrative portions of BeiGene's affirmative action plans for individuals with disabilities and veterans are available for inspection at our offices during normal business hours. Employees and applicants interested in inspecting these plans should contact our Human Resources department by email at firstname.lastname@example.org for assistance.