Director, Clinical Monitoring

vor 17 Stunden

Zug, Schweiz Urovant Sciences Vollzeit

**About Us**

Urovant Sciences, Inc. is a biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions beginning with overactive bladder. Our lead product, GEMTESA®(vibegron), is an oral, once-daily tablet for the treatment of adult patients with overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. GEMTESA is also being evaluated for the treatment of OAB in men with benign prostatic hyperplasia.

**Bring Your Sense of Purpose**

We are Powered by People and Possibilities—which means every voice is heard, and every individual has a role to play in our success. Our fast-paced environment rewards strategic decision-making and collaboration, giving team members opportunities to grow beyond their expertise. Join us as leaders who are moving healthcare forward with vision and purpose.

**Position Description**:
**Primary Responsibilities**:

- The Director, Clinical Monitoring will be responsible for all aspects of monitoring and site management oversight for all of Urovant's CRO partners. 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, directly managing monitoring.
- 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.
- #LI-hybrid_

**General Skills**:

- Desire to be part of a rapidly evolving organization where you will showcase your decision-making, leadership, collaboration, and problem-solving skills.
- Passion to prove yourself as you develop, learn, and grow your knowledge, techniques, and skills.
- Superior written and oral communication skills.
- Proficiency with Microsoft Word, Excel, PowerPoint.
- Excellent interpersonal and collaborative skills, and the ability to work independently and effectively in a highly dynamic environment.
- Enthusiastic, driven, and able to adjust workload based on changing priorities.
- Demonstrated planning and flexibility skills to work across a variety of projects to meet goals and complete work on time.

**Value Competencies**:

- Integrity and Compassion - Empathy, trustworthiness
- Bold Innovation - Inclusive mindset
- Achievement through Collaboration - Courageous communication

If you are interested in creating change for patients, this is a place where you can make a real difference. Click here to join us.

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