Improving quality-of-life through innovations in urology.
Urovant Sciences (Nasdaq: UROV) is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions and 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, an oral, once-daily small molecule beta-3 agonist is being evaluated for overactive bladder (OAB). In December 2019, the Company submitted a New Drug Application to the FDA seeking approval of vibegron for the treatment of patients with OAB. Vibegron is also being evaluated for treatment of OAB in men with benign prostatic hyperplasia (OAB+BPH) and for abdominal pain associated with irritable bowel syndrome (IBS).
Urovant’s second investigational product candidate, URO-902, is a novel gene therapy being developed for patients with OAB who have failed oral pharmacologic therapy.
The Medical Director, Medical Affairs functions as a medical/scientific representative to the Medical Affairs department and cross-functional colleagues. In collaboration with the VP, Medical Affairs, this position is responsible for the design and conduct the Phase IV program; he/she will collaborate across a matrix organization to ensure the Medical Affairs strategy and activities are achieved.
Key Duties and Responsibilities include:
- Providing strategic input into Medical Affairs activities, including data generation, publications, advisory boards, medical information (e.g., standard response documents), and Medical Affairs field-based activities.
- Leading the Phase IV (e.g., registry) program, including developing the protocol, accountability for and oversight of the study conduct and budget, and ensuring the study deliverables are completed per the agreed upon timelines and budget.
- Developing and maintaining effective relationships with external experts, such as key international, national, and regional opinion leaders and experts, professional association leadership, and advocacy organizations.
- Analyzing and reviewing data from relevant internal/external data sources and providing insights to the Medical Affairs team and cross-functional partners, as appropriate.
- Supporting the creation and delivery of scientific and medical content.
- Supporting medical activities at medical and scientific conferences.
- Reviewing clinical development plans and ensuring that Medical Affairs perspectives are considered in these plans.
- Supporting clinical development programs, as needed.
Education and Experience
- MD or DO, or PharmD, or PhD in a scientific discipline required.
- Phase IV study experience required; additional registry experience preferred.
- Minimum 5 years of Medical Affairs experience in the biopharmaceutical industry.
- Urology therapy experience preferred.
- Knowledge of FDA regulations, ICH guidance, and GCP regulations.
Essential Skills and Abilities
- Proficient organizational skills with the ability to manage multiple complex projects/tasks at the same time.
- Excellent written and oral communication skills.
- Highly proficient using Microsoft Word, Excel, PowerPoint, Project, and SharePoint; or similar applications and systems.
- Ability to prioritize tasks and work across locations and time zones.
- A commitment to collaborative leadership, management, teamwork, delegation, and the maintenance of a professional culture based on trust and mutual respect.
- The Medical Director should be able to travel, including international travel, up to 40%, depending on business needs.