A Medical Director directs and manages a medical practice, clinic, lab or public health program. Organizes and manages of staff physicians, policy implementation, and ensures that standards for medical care are communicated and maintained.
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Senior Medical Director -
Patient Safety Florham Park, NJ Function:
Research & Development
Work location type: Hybrid
Job Type:
Full-time
Job ID:
R00149373
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SAVE Company Description About AbbVie AbbVie'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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description The Product Safety Team (PST) lead for late stage 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 oncology programs. PST lead will be responsible to one or more products and will ensuring safety through the product lifecycle (e.g. surveillance, signal detection, validation and assessment, risks assessment and mitigations strategies, tox management, etc…) together with the other members of the safety team (safety scientists, safety architects, safety PM, and other cross functional colleagues). The PST lead will also closely collaborate with a PK and toxicology leads, regulatory and clinical development leads as well as medical affairs colleagues to help guide dose selection and regimen, inclusion/exclusion criteria and safety monitoring for first for clinical trials as well as
PMOS.PST
lead will be interpreting regulations related to pharmacovigilance supporting all patient safety activities, and will be leading the safety components of pre-NDA and NDA/sNDA submissions, regulatory responses, label and label updates, RMPs.
Responsibilities:
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, NDA/sNDA submission - safety component
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, executive leadership and externally, as needed
Effectively write, review and provide input on technical documents independently
Oversight and responsibility for leading the strategy for periodic reports (DSURs, PSURs, PADERs etc.)
Responsible for implementing risk management strategies for assigned products
Proactively engaging, inspiring, coaching and mentoring team and colleagues
Opportunities to co-author publications and participate in initiatives to continue developing and growing as a safety leader
Strong team player, able to adapt and work in a fast pace environment
Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Qualifications MD / DO with 2+ years of internal medicine residency with patient management experience required; PhD or Clinical Pharmacology fellowship is preferred in addition to MD / DO, not required
2-5 years of Pharmacovigilance / Clinical Development experience in the pharmaceutical industry.
Previous experience supporting regulatory submissions (IND/BLA submissions) is required Oncology patient safety experience is required 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 Additional Information Applicable 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 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 and serving our community. Equal Opportunity Employer/Veterans/Disabled. 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 Recruitment Fraud Alert We have recently become aware of various recruitment phishing scams targeting job seekers.
Please be advised:
AbbVie will never request sensitive personal information (such as bank account details, social security numbers, or payment of any kind) during the recruitment process.
If you suspect you have received a fraudulent offer or communication claiming to be from AbbVie, please do not respond, open any attachments, or click on any hyperlinks. If you have any questions or concerns regarding the authenticity of a communication alleged to have been made by or on behalf of AbbVie, please contact us immediately. Protect yourself by verifying job offers and communications. Your safety is important to us.
