Senior Medical Director

Purpose:

The Sr Medical Director will be responsible for one or more pharmaceutical drug products as the Product Safety Team Lead (PSTL). Leads and sets strategy for proactive safety surveillance and risk management. Analyze, interpret, and present safety data to internal and external stakeholders as needed.       

Responsibilities:

• Effectively conduct safety surveillance through the understanding and application of Pharmacology, Chemistry, and non-clinical Toxicology
• Responsible for safety surveillance for pharmaceutical / biological / drug –device combined ophthalmic products
• Lead, set the strategy and, when appropriate, write the key Pharmacovigilance documents. This includes but is not limited to: medical safety assessments, regulatory responses, aggregate safety reports
• Apply current regulatory guidance as appropriate for safety surveillance and authorship of safety documents
• Analyze, interpret, and summarize aggregate safety data and communicate these analysis and interpretation to cross-functional teams and senior management
• Independently write, review, and provide input on technical documents
• Oversight and responsibility for leading the strategy as well as writing, when applicable, the key sections for periodic reports (e.g. DSUR’s, PADER’s and Safety sections of the IBs)
• Lead and set the strategy, in collaboration with the development medical lead of study protocols and informed consents
• Responsible for implementing risk management strategies for assigned product
• Proactively engaging, inspiring, coaching and mentoring team members and colleagues
• Opportunities to co-author publications and participate in initiatives to continue developing and growing as a safety leader

Qualifications:

• MD / DO with 2+ years of residency with patient management experience; Experience in ophthalmology is required; gene therapy experience is preferred
• 5 - 8 years of Pharmacovigilance / Clinical Development experience in the pharmaceutical industry
• Effectively analyze and guide analysis of clinical data and epidemiological information
• Effectively present recommendations / opinions in group environment both internally and externally
• Write, review, and provide input on technical documents
• Work collaboratively and lead cross-functional teams

Key Stakeholders:

Global TA Head MSE, PST Lead, TA Lead, Analytics / Data Scientists, Project Management and Data Management

AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.