Senior Medical Director/Medical Director-Product Safety Team-Early Clinical Safety Oncology
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
The Product Safety Team (PST) lead for early oncology products, under the direction of the Group Lead and TA Head will be actively and closely collaborating with the development medical lead, setting the strategy for the early oncology programs. The PST lead will also closely collaborate with a PK and toxicology leads to help guide dose selection and regimen, inclusion/exclusion criteria and safety monitoring for first in human and phase I/II studies. The PST lead will be responsible and provide safety oversight (e.g. surveillance, signal detection, validation, and assessment) for early oncology products with a proactive approach to clinical safety, and will be interpreting regulations related to pharmacovigilance to support all patient safety activities.
- Understanding and application of the pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance
- Responsible for safety surveillance for pharmaceutical / biological / drug –device combined early oncology products
- Lead, set the strategy and when appropriate write the key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses, 15 day aggregate 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
Position can be hired as a medical director or senior medical director dependent on the selected candidate's education and experience.
- MD / DO with 2+ years of residency with patient management experience; Master Public Health is preferred in addition to MD / DO, not required
- 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
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.