BeOne 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:
The Associate Director, Digital Clinical Operations - Project Lead, is responsible for coordinating and managing digital initiatives within Global Clinical Operations (GCO) to enhance the effectiveness, efficiency, and compliance of operational systems and processes. This role ensures that digital projects and system enhancements are strategically planned, well-governed, clearly communicated, and executed with discipline and transparency.
The candidate will serve as a central point of coordination between business stakeholders, IT, QA, and vendor partners, supporting the delivery of prioritized projects under the Digital Clinical Operations (DCO) portfolio. The role emphasizes operational structure, project execution excellence, and continuous process refinement to ensure digital capabilities meet business needs and regulatory standards.
The Associate Director is expected to:
Coordinate and oversee the delivery of digital projects and system enhancements from initiation through deployment.
Serve as the primary liaison between business stakeholders, IT, QA, and vendors to ensure clear communication, alignment, and timely delivery.
Manage project intake, prioritization, and tracking processes, maintaining transparency and traceability.
Ensure all initiatives adhere to established SDLC or Agile frameworks, documentation, and validation standards.
Monitor progress, risks, and interdependencies, escalating issues proactively to maintain delivery momentum.
Develop project communication materials, including release summaries, stakeholder updates, and governance dashboards.
Support operational efficiency by optimizing project management and governance processes.
Maintain compliance with GxP, validation, and change control standards through structured documentation and oversight.
Contribute to the continuous improvement of DCO project governance, reporting, and delivery frameworks.
Essential Functions of the job:
Project Planning & Execution
Lead or support planning and coordination of multiple concurrent digital initiatives across the DCO portfolio.
Define project scope, deliverables, and timelines in collaboration with business and IT stakeholders.
Manage validation deliverables and ensure adherence to quality and compliance standards.
Track milestones, risks, and dependencies, maintaining visibility and accountability.
Governance & Communication
Administer structured project intake, review, and approval processes.
Facilitate governance discussions, document decisions, and communicate status updates.
Ensure consistent stakeholder engagement and transparent communication across functions.
Compliance & Quality Oversight
Ensure all project activities comply with GxP, 21 CFR Part 11, and internal quality management procedures.
Maintain audit-ready documentation for all project activities.
Promote adherence to change control, testing, and release documentation requirements.
Cross-Functional Collaboration
Partner with business, IT, and QA functions to ensure cohesive project execution.
Collaborate with analytics and process teams to enable data integrity and operational readiness.
Support knowledge sharing, best practices, and continuous improvement across DCO initiatives.
Education/Experience Required:
Bachelor’s degree in Life Sciences, Information Systems, Computer Science, or a related field.
8+ years of experience in Clinical Operations or Clinical Systems Management within a regulated (GxP) environment.
Familiarity with SDLC and Agile methodologies for validated systems.
Knowledge of Oracle Siebel CTMS or similar systems along with PMP or Agile certification preferred.
Computer skills: Proficient in Microsoft Office (Excel, PowerPoint, Project), Smartsheet, and collaboration tools.
Other Qualifications: Strong understanding of clinical trial processes, systems (CTMS, EDC, eTMF), and regulatory standards. Familiarity with Lean Six Sigma or continuous improvement methodologies preferred.
Travel: Up to 20% (domestic and international)
Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
We are proud to be an equal opportunity employer. BeOne 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. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.