Senior Medical Director

Location
Irvine, CA, United States
Posted
Dec 19, 2020
Ref
2020-1312
Hotbed
Biotech Beach
Required Education
Doctorate/PHD/MD
Position Type
Full time
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 is responsible for the content, conduct of the clinical development program and clinical trials in this program. He / she holds responsibility to lead the Clinical development team with all involved functions and vendors/ Contract research organizations and consultants. The Senior Medical Director is responsible for the timelines and budgets of the development programs in collaboration with the Project manager and all functions and has responsibilities for scientific/medical input across multiple programs. The Senior Medical Director may also be a Global Team leader and involved in Business development activities and due diligence. The Senior Medical Director will support the SVP, Clinical Development in medical-clinical matters, as required. The Senior Medical Director should be able to travel, including international travel, for at least 30% of time, depending on business needs.

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 per the agreed upon timelines and budget. Lead medical input for associated programs.
  • Develop the clinical development program and trial protocol in collaboration with all functions, vendors and consultants and 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.
  • Prepare and update timelines and budgets of the clinical development program in collaboration with the Project manager and respective functions.
  • Involvement in internal process improvement activities as SOPs or guidance documents, as assigned.


Education and Experience

  • MD required.
  • 10+ years of experience in clinical development or associated activities.
  • Proof of concept and Phase 3 drug development experience required.
  • Urology or gene therapy experience a plus.
  • Strong leadership experience required.


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.