Senior Manager, Regional Country Clinical Operations Lead

Why Join Us?
Be a hero for our rare disease patients
At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them.
Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.
If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team.
Position Summary:
ultrafocused – Work together to fearlessly uncover new possibilities
The R/CCOL is accountable for study management, study and site oversight as well as site relationship management for a region/country in the Asia Pacific (APAC) region with accountability for all allocated operational study deliverables across programs. The R/CCOL is a key contributor to the strategy of operational activities for a region/country in APAC related to study milestone planning, country and site selection, recruitment planning, investigator relationship management, and site monitoring oversight. The R/CCOL will proactively support several Study Management Teams (SMTs)/Programs in collaboration with Ultragenyx´s key stakeholders including Global Medical Affairs (Patient Find, Patient Diagnosis Liaisons, MSLs, Medical Information), Patient Advocacy, Clinical Operations Program Leads, Lead Study Managers and Global Investigator Site Monitoring and Management.
The R/CCOL will optimize performance with a focus on high quality, time and cost effectiveness, following quality standards, SOPs and guidelines aligned with local regulations and ICH/GCP guidelines by being a champion of the Ultragenyx patient centric culture. Outstanding interactions between Ultragenyx as a Sponsor with rare disease investigator sites is key to optimizing strong relationships and successfully executing our clinical trials. The R/CCOL will work with the Exec Director, Global Clinical Operations to drive operational excellence for Global Clinical Operations.
Work Model:
Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.
Responsibilities:

• Effectively oversee the conduct of one or more trials, in one or more countries or region
• Drive country/region study deliverables, project timelines and milestones, as well as quality and compliance of the study in alignment with the global plan
• Facilitate strategic and tactical exchange of program, study, site level information and communication between UGX APAC community, including country affiliates, and Global Study Teams
• Act as a Subject Matter Expert for policies and country/regional regulations and for Sponsor Inspections by Regulatory Agencies or during audits
• Build and maintain effective relationships with investigator sites and internal/external stakeholder groups
• Coordinate and execute planning, startup, recruitment, maintenance and close-out activities at the study level across the assigned region/country
• Act as a point of contact and demonstrate leadership in the resolution of high/critical regional/country study or site issues
• Collaborate with CRO partners to proactively find solutions to meet any challenges to the study deliverables and project timeline milestones
• Provide strategic regional/country input into and review of key study specific study documents and training materials
• Identify potential study sites in collaboration with the study team, local Medical Affairs, and CRO
• Conduct feasibility assessment and make recommendations for site selection
• Support site initiation and close-out visits at selected clinical sites
• Manage implementation of Monitoring Oversight Plan and conduct selected Monitoring Oversight Visits with CRAs
• Review site visit reports for quality and completeness
• Support the Study Management Team in Sponsor and protocol level training in the country/region
• Support maintenance of Trial Master File to ensure study is always inspection ready
• Review quality metrics and provide solutions for continuous improvement
• Maintain a working knowledge of rare/ultrarare disease and protocols
• Support risk and issue management at country/region level
• Interact with other R/CCOLs to standardize study conduct and clinical monitoring processes across studies, and drive operational excellence
• Participate in initiatives and/or special projects, as assigned
• Participates in the development, review and implementation of Standard Operating Procedures, Work Instructions, Guidance Documents
• May mentor Clinical Operations staff (e.g., Study Engagement Leads)
• May serve as a people leader of one or more direct reports within a matrix environment, including, performance management, oversight and development plan guidance
  

Requirements:

• Bachelor’s degree or equivalent is required (scientific or healthcare discipline preferred)
• 12 plus years of extensive site management and monitoring experience across various disease areas and previous experience managing day-to-day operations of clinical trials
• Holding CRA certificate is highly considerable
• Solid knowledge of clinical development processes with strong emphasis on monitoring
• Excellent ability to manage and collaborate on complex protocols within a matrix environment
• Expert knowledge of both ICH and Japan Good Clinical Practice guidelines
• Excellent planning and organizational skills
• Able to handle multiple tasks and deadlines
• Must be self-motivating and able to work on problems of moderate scope and complexity where analysis of situations or data requires a review of a variety of factors
• Highly effective verbal and written communication skills
• Flexible and solution focused
• Strong customer focus
• Must have the ability to build and maintain positive relationships with clinical sites, peers and management
• Experience with partnering and managing CRO relationships
• Experience using computer applications including spreadsheets, MS Project, email, word-processing software and web-based systems
• Japanese native speaker and excellent written and verbal skills in English and Japanese
• 25% travel, dependent on need
  

Desired:

• Rare disease experience
• Additional language skills
  

Full Time employees across the globe enjoy a range of benefits, including, but not limited to:

• Generous vacation time and public holidays observed by the company
• Volunteer days
• Long term incentive and Employee stock purchase plans or equivalent offerings
• Employee wellbeing benefits
• Fitness reimbursement
• Tuition sponsoring
• Professional development plans
• Benefits vary by region and country
  

Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at talentacquisition@ultragenyx.com.
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