Senior Director Pharmacovigilance - Irvine, CA
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. Urovant is a biotechnology 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, an oral, once-daily small molecule beta-3 agonist being evaluated for overactive bladder (OAB). In addition to OAB, vibegron is being evaluated for two additional potential indications: the treatment of OAB in men with benign prostatic hyperplasia (BPH) and the treatment of abdominal pain associated with irritable bowel syndrome (IBS).
Urovant’s second investigational product candidate, URO-902, is a novel gene therapy for patients with overactive bladder symptoms who have failed oral pharmacologic therapy.
The Senior Director, Pharmacovigilance is responsible for all aspects of Pharmacovigilance within the organization.
The position is based at Urovant’s site in Irvine, CA and reports to the Chief Medical Officer.
· Leadership and organization of the 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.
· Establish 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.
Essential Skills and Abilities
· Leadership and collaborative capabilities for cross functional teams.
· 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.
Job Type: Full-time
- Health insurance
- Dental insurance
- Vision insurance
- Retirement plan
- Paid time off
- Flexible schedule
- Parental leave