Executive Director Drug Safety & Pharmacovigilance

Location
Irvine, CA, United States
Posted
Dec 18, 2020
Ref
2020-1314
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 Executive Director, Drug Safety & Pharmacovigilance is responsible for all aspects of Drug Safety & Pharmacovigilance within the organization.

The position is based at Urovant Sciences site in Irvine, CA and reports to the Chief Medical Officer.

Key Duties and Responsibilities

  • Leadership and organization of the Drug Safety & Pharmacovigilance function and all safety aspects in clinical trials in collaboration with all functions and vendors for all clinical development programs and establish the procedures for post-marketing pharmacovigilance.
  • Provides input and responsible for the safety aspects of periodic regulatory safety reports, the Investigator's Brochures, Informed Consents, clinical study protocols, clinical study reports, safety sections of the INDs or IMPDs or other regulatory documents, safety aspects of the CTD modules, and regulatory labels and other documents, including Medical Monitoring plans and Safety Management Plans.
  • Develop the budgets and updates and management of contracts for the Pharmacovigilance function with the safety vendors in collaboration with the Head of Project Management, Finance and Core and Clinical Development Team Leaders and other relevant functions.
  • Collaborate and oversee the Safety Scientist function.
  • Involvement in business development activities and due diligences and working with Business Partners.
  • Involved in internal process improvement activities such as SOPs or guidance documents, as assigned.
  • Supervise direct reports, including review of performance and working on training needs for further development of the direct reports.


Education and Experience

  • MD degree required.
  • 10+ years of experience in global clinical safety for development projects and Pharmacovigilance of marketed products.
  • Strong leadership and collaborative capabilities for cross functional teams.
  • Urology therapy experience preferred.
  • Knowledge of FDA regulations, ICH guidance, and GCP regulations.


Essential Skills and Abilities

  • Good organizational skills.
  • Excellent communication skills, both verbally and in writing.
  • Strong presentation skills, including presentations to senior management, external audiences and experts.
  • Ability to work across locations and time zones.
  • Ability to work on several projects and assignments at the same time and also prioritize tasks.
  • Strong financial business acumen and analytical skills.
  • Strong interpersonal skills and ability to confront issues with vendors and cross-functional team members for a win-win outcome.
  • Thorough understanding of ICH Good Pharmacovigilance Practices and Good Clinical Practices, including broad application of knowledge in different therapeutic areas.
  • Knowledge of MedDRA and Argus or similar applications and systems.
  • A commitment to collaborative leadership, management, teamwork, delegation and the maintenance of a professional culture based on trust and mutual respect.
  • 30% travel, including international travel, depending on business needs.