Senior Medical Director-Late Stage Oncology

Senior Medical Director-Late Stage Oncology

Join to apply for the Senior Medical Director-Late Stage Oncology role at Abb Vie

$/yr - $/yr

Abb Vie'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 Abb Vie, please visit us at  Follow @abbvie on X, Facebook, Instagram, You Tube, Linked In and Tik Tok.

The Product Safety Team (PST) lead for late stage oncology products, under the direction of the Group Lead and TA Head, will actively and closely collaborate with the development medical lead, setting the strategy for the oncology programs. The PST lead will be responsible for one or more products and will ensure safety through the product lifecycle (e.g., surveillance, signal detection, validation and assessment, risk assessment and mitigation strategies, tox management, etc.)

together with 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 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.

The PST lead will interpret regulations related to pharmacovigilance supporting all patient safety activities and will lead the safety components of pre‑NDA and NDA/sNDA submissions, regulatory responses, label and label updates, and RMPs.

• 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 analyses and interpretations 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 engage, inspire, coach and mentor 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‑paced environment
• Significant Work Activities – Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8‑hour day)

• MD / DO with 2+ years of medical residency with patient management experience required;
  PhD or Clinical Pharmacology fellowship is preferred in addition to MD / DO, not required
• 5‑8 years of Pharmacovigilance (PST lead role equivalent) / Clinical Development experience in the pharmaceutical industry required
• Oncology experience strongly preferred
• 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

• 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…