Director, Clinical Monitoring

Urovant Sciences is a biopharmaceutical company focused on developing and commercializing innovative therapies for urological conditions. 

Every employee at Urovant plays an integral role to our success.  We are ambitious in our approach to improving outcomes for the patients and healthcare providers we serve.  Our fast-paced environment rewards strategic decision-making and collaboration, giving team members opportunities to grow beyond their expertise.

The Company's current area of research focus is Urological disease.  Urovant Sciences is currently investigating treatments for OAB in men with benign prostatic hyperplasia (BPH), as well as an earlier stage gene-therapy for OAB in patients who have failed oral pharmacologic therapy.  Urovant Sciences, a subsidiary of Sumitovant Biopharma Ltd., intends to develop novel treatments for additional urologic diseases. Learn more at www.urovant.com.

Position Description

The Director, Clinical Monitoring should be able to travel, including international travel, for at least 25% of time, depending on business needs.  He/she needs to be able and willing to work across time zones

The employee must conduct their work activities in full compliance with defined expectations, including Urovant Science's internal requirements, GMP and ISO, and all other applicable health authority.  Urovant Sciences, Inc. internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives. 

For all Urovant studies, will work with the selected CROs to ensure global monitoring quality, timeliness, monitoring oversight performance, productivity and delivery. The role is the primary point of contact for oversight monitoring with the CRO and is the pathway for monitoring strategy and monitoring oversight issue escalation.  The role is accountable for study specific monitoring strategies, including defining the monitoring and monitoring oversight strategies, developing monitoring plans and oversight monitoring plans, review of monitoring reports, performance of monitoring oversight visits, and providing input into budgets and cost management related to monitoring activities.

Key Duties and Responsibilities

• The Director, Clinical Monitoring will be responsible for all aspects of monitoring and site management oversight for all of Urovant's clinical trials. He/she will work closely with Urovant's Clinical Operations Leads, Data Management, and QA, as well as with all involved functions and vendors (such as Contract Research Organizations [CROs]). 
• She/he will act as the primary contact within Urovant for all aspects of monitoring and site management and will contribute to the preparation of study plans with the respective CROs, development and measurement of monitoring key performance indicators, ensuring delivery of quality operational results, and will be involved with the selection and oversight of applicable Clinical Operations vendors.
• She/he will be responsible to ensure consistency of process and approaches across global monitoring on all Urovant trials, and will work directly with the CRO monitoring organizations on ensuring quality monitoring deliverables through monitoring report review, observational visits, identification/mitigation of monitoring issues and compliance to study plans
• Working within the Clinical Operations organization, Director/Senior Director Global Clinical Monitoring will collaborate with Clinical Operations Leads, Clinical Development and/or Medical Affairs, Project Managers, and Finance on budgets related to monitoring oversight activities on assigned studies
• The Director/Senior Director Global Clinical Monitoring may mentor or supervise other employees or contractors within the Clinical Operations Team
• The Director/Senior Director Global Clinical Monitoring may develop/contribute to process development/improvement within Urovant in Clinical Operations, R&D, in Europe, as well as at the company level.

Education and Experience

• Health or Biological Science degree required; BS or MS preferred
• At least 10 years of experience in clinical monitoring, with at least 5 years of experience in global clinical trials in a monitoring management capacity
• Experience in monitoring all phases of clinical trials required
• Previous experience at a sponsor/pharmaceutical company preferred

Essential Skills and Abilities

• Demonstrates leadership capabilities in cross functional teams
• Good organizational skills
• Good verbal and written communication skills
• Good presentation skills
• International travel required
• Ability to work across locations and time zones
• Ability to work on multiple projects and assignments at the same time
• Ability to prioritize tasks
• Strong financial business acumen and analytical skills
• Strong interpersonal skills and ability to manage multiple vendors
• Thorough understanding of ICH Good Clinical Practices, Clinical Safety Data Management, clinical trials management (including protocol design, data management, site monitoring, statistical reporting, report writing), regulatory compliance, auditing including broad application of knowledge in different therapeutic areas, as well as specific European standards pertaining to these areas

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