BeOne Medicines · 2 hours ago
Senior Director, Head of Global Clinical Process Management
United States
Full-time
Remote
Director/Executive
$206K/yr - $276K/yr
12+ years expBeOne Medicines is a rapidly growing company focused on fighting cancer, seeking a Senior Director to lead Global Clinical Process Management. This role involves designing, implementing, and optimizing clinical operations processes to enhance efficiency and quality across multiple regions.
Pharmaceuticals
Responsibilities
Strategically lead all efforts related to ensuring clinical operations process excellence
Conduct gap analyses; identify potential risks to clinical operations related to process and inspection readiness; operationalize mitigation strategies in collaboration with key stakeholders/leadership
Strategically evaluate and implement solutions to address any operational geographic gaps related to ensuring clinical operations process team is set up for optimal execution
Optimize current state clinical operations processes and maintain document lifecycle management and continuous process improvements
Develop and communicate future state strategies to clinical operations leadership team
Support organizational change management efforts for Clinical Operations
Provide strategic expertise and facilitate leadership alignment of cross functional SOPs
Effective partnership and collaboration with cross functional leaders/stakeholders (e.g. Clinical Development, Data Management, Quality, Regulatory) as it relates to planning, interdependencies, and risk mitigations for global processes
Partners with cross functional teams, Global Clinical Operations Global Process Owners to design and implement a clear, well-defined process with clear inputs, outputs, and roles & responsibilities – integrates people, process, and technology components of process design
Leads Global Clinical Operations process improvement teams/workstreams tasked with re-designing or improving processes including establishing timeline for process improvement projects
Develops process maps and other process documentation to facilitate the team’s analysis and optimization of processes
Assists Global Clinical Operations, Global Process Owner with change management and implementation of process improvements
Keep Global Clinical Development key stakeholders and other relevant functions informed of new processes or process updates requiring SOP updates owned by Global Clinical Operations function. Reviews SOPs and training documentation resulting from these new processes or process improvements
Chair Global Clinical Operations SOP Governance Board. Develop and maintain Governance charter, process
Monitor key metrics and partners with Global Clinical Operations, Global Process Owner to identify and address gaps/deficiencies
Works with CRO partners to ensure optimization of key process interfaces to ensure seamless integration of internal and external activities as required
Works with Global Process Owner to capture and communicate Lessons Learned
Develops direct and indirect reports to enhance the business across all areas
Leads and develops staff, including mentoring, coaching, and performance management
Qualification
Required
Bachelor's Degree with minimum of 12+ years of experience in pharmaceutical or biotechnology drug development
Mid/large pharma experience (preferably clinical operations, process, quality, or compliance roles)
ICH GCP subject matter expert
Knowledgeable of regulatory requirements (e.g., FDA, MHRA/EMA)
Experience working in a cross-functional, global environment
Strong written and verbal communication skills
Deep experience and expertise in end-to-end clinical trial processes including experience in one or more key functions (e.g., clinical research, clinical operations, data management, biostatistics, project management)
Strong leadership, collaboration, and influencing skills in a complex, matrix environment including team leadership or project management
Experience in clinical trial process design, harmonization/optimization, and implementation
Understanding of industry trends (e.g., regulatory, technology) with ability to apply them to process improvement
Efficient in Microsoft suite (Excel, Outlook, Word, PowerPoint and Project)
Preferred
Master's degree preferred
Six Sigma certification and/or experience with process mapping tools (e.g., Visio, Power Point) desirable
Benefits
Medical
Dental
Vision
401(k)
FSA/HSA
Life Insurance
Paid Time Off
Wellness
Company
BeOne Medicines
BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more accessible to cancer patients worldwide.
10001+ employees
H1B Sponsorship
BeOne Medicines has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (20)
Funding
Current Stage
Late StageCompany data provided by crunchbase