Senior Medical Director

Overview

Improving quality-of-life through innovations in urology.

Urovant Sciences, Inc. is a 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, GEMTESA® (vibegron), is an oral, once-daily (75 mg) small molecule beta-3 agonist approved by the U.S. FDA in December 2020 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 (OAB+BPH).

Urovant's second product candidate, URO-902, is a novel gene therapy being developed for patients with OAB who have failed oral pharmacologic therapy.

Position Description

The Senior Medical Director, Clinical Development leads the cross-functional Clinical Development team and is responsible for the scientific medical-clinical input into program and project development plans, clinical trial protocols and conduct of the clinical trials for a specific program. The Senior Medical Director is accountable for the scientific medical development of the clinical trial protocols and working with the Clinical team and Project Managers on timelines and budgets for development programs. Collaborates with statisticians on the statistical analysis plans, the interpretation of the trial results and the clinical trial reports. May also be a Global Team leader and involved in Business development activities and due diligence. Supports the SVP, Clinical Development in medical-clinical matters, as required.

Key Duties and Responsibilities

• Leadership of the cross functional Clinical Development team in collaboration with all functions, vendors/ contract research organizations and consultants, as applicable for the agreed upon timelines and budget. Lead medical input for associated programs.
• Develop the clinical development program and trial protocols in collaboration with all functions, vendors and consultants.
• Responsible for Clinical sections of Investigator brochures, Clinical study reports, presentations, briefing documents and submissions in collaboration with all functions, vendors and consultants.
• Involvement in Business Development activities and due diligence.
• Input into development plans for clinical development in collaboration with the Project Manager and respective functions, working with the Project Manager and the Clinical Development team on timelines and budgets.
• Involvement in internal process improvement activities such as SOPs or guidance documents, as assigned.

Education and Experience

• MD required.
• 10+ years of clinical research experience.
• 5+ years pharmaceutical industry experience.
• Phase 2a to and Phase 3 drug development experience required.
• Urology or gene therapy experience a plus.
• Experience leading cross-functional teams a plus.

Essential Skills and Abilities

• Leadership capabilities for cross functional teams.
• Good organizational skills.
• Good communication skills, both verbally and in writing.
• Good presentation skills, including presentations to Senior management and external audiences and experts.
• Ability to work across locations and time zones.
• Ability to work on several projects and assignments at the same time.
• Ability to prioritize tasks.
• 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.
• A commitment to collaborative leadership, management, teamwork, delegation, and the maintenance of a professional culture based on trust and mutual respect.
• Travel, including international travel, for at least 30% of time, depending on business needs.