Senior Medical Director-Late Stage Oncology

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 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 :

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 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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys 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  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more :

Work :

No

Employment Type : Full-time

Key Skills

EMR Systems,Post Residency Experience,Occupational Health Experience,Clinical Research,Managed Care,Primary Care Experience,Medical Management,Utilization Management,Clinical Development,Clinical Trials,Leadership Experience,Medicare

Experience : years

Vacancy : 1