Senior Medical Director- Early Development Oncology

About the Company

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.

About the Role

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, ensuring 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.

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 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).

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
• Oncology experience strongly preferred
• Effectively analyze and guide analysis of clinical data and epidemiological information
• Effectively present recommendations/opinions in group environments 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

Pay

The compensation range described is the range of possible base pay compensation that AbbVie believes in good faith it will pay for this role at the time of posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and the company may ultimately pay more or less than the posted range. This range may be modified in the future.

Benefits

• Comprehensive package of benefits including paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k) to eligible employees
• Eligibility to participate in long-term incentive programs