Company DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job DescriptionPurpose:Manages other Associate Medical Directors, Medical Directors, Senior Medical Directors. LeadingProduct Safety Teams (PST) and PST leads (and could support one large product as the PST Lead) and ensuring safety of late stage and post marketing hematology-oncology portfolio (e.g. surveillance, signal detection, validation and assessment). Interpreting regulations related to pharmacovigilance supporting all patient safety activities. Experts on hematology-oncology late stage group of assets with similar mechanism of action (overarching across assets)Responsibilities:
Connectors within R&D particularly with key functions (Reg, ASL, Risk Mgt, etc)
Asset strategy lead safety representatives for larger programs (late stage)
Understand MOA in close collaboration with preclinical, clinical pharmacy, clinical development, and discovery
Works closely with Executive Medical Director to establish safety strategy for each indication and across assets with similar MOA
Leads and guide the safety physicians on data review (clinical and beyond) and interpretations across assets with similar MOA
Proactively seeks to understand “WHY” a safety concern or risk emerge and “How” to mitigate it
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 products
Lead and set the strategy for key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses and risk management plans
Apply current regulatory guidance as appropriate for safety surveillance and authorship of PV documents
Analyze and interpret aggregate safety data and communicate these analysis and interpretation to cross-functional teams
Effectively write, review and provide input on technical documents independently
Oversight and responsibility for leading the strategy for periodic reports (PSUR’s, PADER’s etc.)
Oversight of safety surveillance and pharmacovigilance activities for products in clinical trials and post marketing
Responsible for implementing risk management strategies for assigned products
Proactively engaging, inspiring, coaching and mentoring team and colleagues
Manages other Associate Medical Directors, Medical Directors, Senior Medical Directors: performance and talent management, coaching and development.
Assumes responsibility for coordinating and overseeing safety related activities at a product level across multiple indications or multiple related products for the same indication. Is responsible for assessing product safety strategy across the entire program and for overseeing approval related activities.
Qualifications
MD / DO with 2+ years of residency with patient management experience
Master Public Health or PhD is preferred in addition to MD / DO, not required
8 - 10 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
Ability to lead cross-functional teams in a collaborative environment
Fluency, both written and oral, in English
Evaluate and make independent decisions. Ability to work effectively in the situation of uncertainty and complexity, ability to multitask
Experiences / Leadership traits:
Ability to work collaboratively with colleagues with different areas of expertise (e.g epidemiology, statistics)
Ability to make independent decisions
Ability to influence cross functional stakeholders - internal and across industry, and regulatory authorities
A clear understanding of PV and clinical development and monitoring clinical trial and post -marketing safety
Ability to respect other opinions and be inclusive of the different point of views and be open to the ideas of others
Additional InformationApplicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
This job is eligible to participate in our long-term incentive programs
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. 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 protected veteran, or any other legally protected group status.US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:https://www.abbvie.com/join-us/reasonable-accommodations.html
