Director, Medical Science Liaisons (MSLs)

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 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, an oral, once-daily small molecule beta-3 agonist is 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.

 

Position Description:

The Director, Medical Science Liaisons (MSLs) is responsible for providing leadership and strategic direction to a team of high performing urology and Managed Markets/Long-term care medical science liaisons (MSLs). The Director, MSLs is a high visibility leadership role with ultimate accountability for the effectiveness and compliance of scientific exchange conducted by the MSL teams to meet the needs of healthcare professionals in a variety of settings, including clinicians, researchers, advocacy groups, and other external and internal stakeholders.

 

Responsibilities include:

 

  • Managing Medical Science Liaison (MSL) and Managed Markets/Long Term Care MSL (MM/LTC MSL) teams
  • Provides oversight and leadership that ensures effective and compliant interactions between MSLs and internal/external stakeholders. Ensures medically/scientifically balanced and compliant communications on Urovant commercialized products, development programs and disease states
  • Hires, trains, coaches and develops the field-based medical team; includes setting measurable goals and ensuring team members execute successfully against the field medical strategy
  • Assists the VP, Medical Affairs in developing Medical Affairs strategy that encompasses the field-based medical organization
  • Organizes and communicates to cross-functional stakeholders the insights the MSL team gains about competitive landscape, unmet needs of researchers, physicians and advocacy groups; develops actionable plans to address insights
  • Oversees and participates in the creation and dissemination of effective, compliant, medically-sound information tools for use by MSLs to support the safe and effective use of company marketed products
  • Contributing to the development of the Medical Affairs strategy, and creating and aligning the field medical strategy with the overall scientific platform
  • Identifying and creating medical tools for the field-based medical teams
  • Setting measurable goals and ensuring implementation and execution of medical strategies through the field based MSL teams
  • Providing field insight reports and contributing to actionable strategy plans
  • Participating and collaborating in in cross-functional meetings
  • Participating in medical and scientific congresses
  • Hiring, training, coaching, performance review, and professional development of direct reports
  • Managing the field-based medical budget

 

The Director, Medical Science Liaisons (MSLs) should be able to travel, including international travel, for at least 60% of time, depending on business needs.

 

Education and Experience

  • MD/DO, PharmD, or PhD in scientific field required
  • 8+ years of Medical Affairs experience within the pharmaceutical or biopharmaceutical industry
  • 5+ years of MSL experience, 3+ years of line management experience
  • Field-based MSL management experience preferred
  • Urology experience preferred
  • Business degree (MBA) preferred
  • Knowledge of FDA regulations, ICH guidance, and GCP regulations
  • Possession of a valid state Driver’s License

Essential Skills and Abilities

 

  • Proficient organizational skills with the ability to manage multiple complex projects/tasks at the same time
  • Excellent written and oral communication skills
  • Highly proficient using Microsoft Word, Visio, Excel, PowerPoint, Project, and SharePoint; or similar applications and systems
  • Ability to prioritize tasks and work across locations and time zones
  • A commitment to collaborative leadership, management, teamwork, delegation, and the maintenance of a professional culture based on trust and mutual respect

Associate Manager, Regulatory Advertising Promotion

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 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, 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 Associate Manager, Regulatory Advertising Promotion is responsible for supporting Urovant’s Regulatory Affairs Advertising and Promotion function and coordinating the Promotional Review Committee (PRC) process, facilitating review and approval of promotional materials for Urovant’s products.

The position is based at Urovant’s site in Irvine, CA and reports to the Executive Director, Regulatory Advertising Promotion

Responsibilities include:

  • Facilitate the PRC process, communicating established Urovant standards for creation and dissemination of reviewed materials in accordance with appropriate SOPs.
  • Develop and maintain productive working relationships with colleagues and vendors contributing to development, review, and approval of Urovant’s promotional materials, including Marketing/Commercial (and their Agencies), Legal, Compliance, Regulatory Affairs/Labeling, and Medical Affairs.
  • Ensure appropriate training of participants in the PRC process by developing and maintaining training materials, as appropriate.
  • Schedule and manage PRC meetings, working with Marketing to ensure that agendas are appropriate. Capture and document review comments during PRC meetings.
  • Route jobs for review through the designated electronic system(s) for the PRC process.
  • Document and ensure follow-up on deviations from the standard PRC process.
  • Work closely with the Legal and Compliance departments to address identified issues, as needed.
  • Engage with R&D colleagues in Project Management, Clinical, CMC, Regulatory, Quality, and Medical Affairs, as appropriate, to meet team and functional goals.
  • Provide promotional labeling and advertising review support to Regulatory Affairs Advertising and Promotion colleagues.
  • Proofread final copy to ensure all PRC process feedback has been incorporated.
  • Provide final QC review and approval of promotional material.
  • Participate in proofreading of product labeling components, package inserts, brief summaries as required, by requested deadlines.
  • Support preparation of FDA Form 2253 submissions and requests for advisory comment submissions to FDA’s Office of Prescription Drug Promotion (OPDP), as applicable.

 

Education and Experience

  • Bachelor’s degree in science or health related discipline
  • 2 plus years of Regulatory Affairs Ad Prom, Labeling, or equivalent experience.

 

Essential Skills and Abilities

  • Ability to work in a team environment
  • Working knowledge of prescription product advertising regulations
  • Strong project management skills and ability to perform/prioritize multiple tasks in a fast-paced, deadline-driven environment with limited supervision
  • High level interpersonal skills with the ability to influence others, internally and externally, in a positive and effective manner
  • Exceptional detail-oriented focus, with the ability to promptly assess documents for accuracy as well as consistency
  • Accurate and concise oral and written communication abilities
  • Able to innovate, analyze, and solve problems
  • Exceptional communication skills, both verbally and in writing
  • Proficiency with software/systems (e.g. Veeva, Microsoft Word/Excel/PowerPoint)
  • A commitment to collaborative teamwork and the maintenance of a professional culture based on trust and mutual respect

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