Manager, Clinical Operations
Improving quality-of-life through innovations in urology.
Urovant Sciences is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions. Urovant is a nimble company with an entrepreneurial focus on improving the way providers and their patients confront urologic diseases that are difficult to treat.
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.
Urovant’s lead product candidate, vibegron, is a β3-adrenergic agonist being developed for an oral, once-daily treatment for overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency. In addition to OAB, Vibegron is being developed for two additional potential indications: the treatment of OAB in men with benign prostatic hyperplasia (BPH) and the treatment of pain associated with irritable bowel syndrome (IBS).
Urovant’s second investigational product candidate, URO-902, is a novel gene therapy for patients with overactive bladder symptoms who have failed oral pharmacologic therapy.
The Manager, Clinical Operations will ensure that clinical strategies are translated into operational plans for assigned studies. Works within the Clinical Operations team and with all involved functions and vendors, such as contract research organizations, and is involved with the selection and oversight of the Clinical Operations vendors. Also works closely with Clinical Development, Project Managers, and Finance on timelines and budgets on assigned studies.
The position is based at Urovant’s site in Irvine, CA and reports to the Senior Director, Head of Clinical Operations.
- Act as the Clinical Operations team representative on assigned programs and will collaborate with all functions and vendors per the agreed upon timelines and
- Provides input into clinical study protocols, clinical study reports, and other clinical documents as appropriate on assigned studies. Contribute to the development of the Master Informed consent for clinical studies.
- Contribute to the Clinical Operations plans and budgets and update timelines and budgets of the clinical development programs in collaboration with the Clinical Team Leader, Project Manager, and other relevant functions on assigned studies.
- Involved in internal process improvement activities such as SOPs or guidance documents, as assigned
Education and Experience
- Health or Biologics Science degree required.
- At least 5+ years of experience in clinical development operations for global clinical trials.
Essential Skills and Abilities
- Self-starter, work independently, prioritize tasks and has initiative to take on unfamiliar tasks.
- Strong organizational and communication skills, (both written and oral).
- Strong interpersonal skills and ability to manage vendors.
- Strong financial business acumen and analytical skills.
- 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 and auditing including broad application of knowledge in different therapeutic areas.
- Able to work in a fast-changing environment.
- Ability to work across locations and time zones.
- Travel, including international travel, for at least 20% of time, depending on business
Interested candidates should contact: firstname.lastname@example.org, job reference MCO
Learn more at https://www.urovant.com