About Dermavant:

Dermavant Sciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies for inflammatory skin diseases and medical dermatologic conditions.We are passionate and dedicated to realizing the full potential of biomedical research and to developing and commercializing novel first-in-class or best-in-class therapies that improve patients’ lives. The patient is at the heart of everything we do.

Position:

The Senior Director, Pharmacovigilance will oversee global pharmacovigilance activities for all clinical programs, including activities performed at Clinical Research Organizations and in collaboration with partners. Ensure compliance with regulatory requirements, internal procedures and policies, GxP, and readiness for regulatory inspections and audits. The experienced individual will have excellent people management skills, advanced safety data review/analysis experience, superb written and verbal communication skills, as well as hands-on pharmacovigilance experience with a proven track record of major accomplishments.

Responsibilities:

• Chair of the Executive Safety Review Committee responsible for overseeing safety assessments of all assets in the company portfolio as well as review and approval of safety decisions.
• Leading safety and adjudication oversight on cross-functional Product Safety Review Committees with close collaboration of colleagues from regulatory, clinical development, clinical operations, nonclinical, bioanalytical and CMC.
• Responsible for the oversight and collaborate with pharmacovigilance and drug safety colleagues from CROs and development partners to align on a harmonized approach to identifying, evaluating and communicating safety issues.
• Authoring and/or providing input to pharmacovigilance policies and standard operating procedures.
• Build, lead and mentor a team of high performing pharmacovigilance professionals.
• Perform and/or provide oversight for the medical review of safety events to ensure accuracy and completeness of safety information, and to ensure consistency of medical coding of safety data.
• Author, review and approve safety sections of clinical documents, safety portion of protocols, statistical analysis plans, annual reports, clinical study reports, investigator brochures, and aggregate safety documents.
• Work closely with Regulatory Affairs regarding assessment and submission of individual case safety reports (ICSRs), aggregate reports, IND annual reports or DSURs, and all other relevant regulatory communications.
• Responsible for the safety strategy during drug development, including development and implementation of Risk Management Plans, and monitoring and analysis of cumulative safety information in the context of the benefit-risk profile.
• Develop and implement best in class pharmacovigilance practices and procedures commensurate with stage of development of clinical programs.

Qualifications:

• PharmD or MD; MD preferred.
• Minimum of 7 years of pharmacovigilance experience within the pharmaceutical/biotechnology industry; experience in dermatology preferred.
• At least 5 years in a pharmacovigilance leadership role, with demonstrated skill in leading teams and managing pharmacovigilance departments.
• Experience in drug development from Phase I-IV, including health authority interactions, and experience with NDA, NDS or BLA submissions.
• Outstanding leadership qualities with technical and emotional intelligence.
• Experience and success interacting with Regulatory authorities (FDA, HC, EMA, etc.), Advisory Committee meetings, or other scientific advice forums.
• Excellent communication and presentation skills; successful track record of communicating with executives and senior level scientific management as well as external representation of company.
• Knowledge of pharmaceutical research and development, global PV regulations, FDA, EU, and ICH regulations, GxP requirements/guidelines, and experience with common safety databases.
• Ability to effectively collaborate in a dynamic, fast-paced, and ambiguous environment.

What we look for in our people:

• Highly motivated self-starter with an entrepreneurial spirit and commitment to personal and career development.
• Desire to work in a quickly changing and fast-paced growing business.
• Unrelenting dedication to delivering results and a desire to shape the strategic goals of the business. Willing to roll up your sleeves to get the job done.
• Ability to overcome ambiguity and challenge the status quo
• Manage multiple programs with competing and aggressive time lines, prioritize activities, and work independently.
• Excellent written and oral communication skills; experienced presenter of key messages to broad audiences including Senior Stakeholders