Director, Quality - Clinical & CMC

Location
Irvine, CA
Posted
Oct 12, 2018
Ref
DQ
Required Education
Bachelors Degree
Position Type
Full time

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. 

Urovant's second investigational product candidate, hMaxi-K, is a novel gene therapy for patients with overactive bladder symptoms who have failed oral pharmacologic therapy.

This role has oversight of the quality aspects of Clinical and Chemistry, Manufacturing, Controls (CMC).  Will oversee compliance with good clinical practice (GCP), good manufacturing practice (GMP) for small molecules and biologic pharmaceuticals and ISO.  Will conduct internal audits, CRO/CMO audits, manage health authority inspections, and drive corrective and preventive actions (CAPAs).  Develop and oversee quality management system and associated process and controlled documents (e.g. SOPs and quality manuals).   Responsible for ensuring compliance of drug development activities with applicable global regulations.  Scope may also include medical device products. 

Education and Experience

  • Bachelor’s degree; advanced/graduate degree preferred.
  • 10+ years experience in Quality - Clinical and CMC related role.

Essential Skills and Competencies

  • 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.
  • Ability to effectively manage contract resources and/or FTEs. 
  • Excellent interpersonal, reading, writing, communication and public presentation skills, along with excellent organizational and management skills. 
  • Proven leadership skills and the ability to pull together and lead new teams.
  • Strong problem resolution and conflict resolution skills. 
  • Strong business acumen and analytical skills.
  • Strong financial and budget skills and experience.
  • Exceptional project management skills and ability to provide management oversight on projects being managed by others.
  • Successful track record of working in a matrixed organization and building strong relationships with other organizations.
  • Ability to travel.

Learn more at http://www.urovant.com