Senior Medical Director-Early Oncology Clinical Safety
5 months ago
Company Description
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 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 Description
Purpose:
The Product Safety Team (PST) lead for early 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 early oncology programs. The PST lead will also closely collaborate with a PK and toxicology leads to help guide dose selection and regimen, inclusion/exclusion criteria and safety monitoring for first in human and phase I/II studies. The PST lead will be responsible and provide safety oversight (e.g. surveillance, signal detection, validation, and assessment) for early oncology products with a proactive approach to clinical safety, and will be interpreting regulations related to pharmacovigilance to support all patient safety activities.
Responsibilities:
Understanding and application of the pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillanceResponsible for safety surveillance for pharmaceutical / biological / drug device combined early oncology products
Lead, set the strategy and when appropriate write the key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses, 15 day aggregate reports.
Apply current regulatory guidance as appropriate for safety surveillance and authorship of safety documents
Analyze, interpret, and summarize aggregate safety data and communicate these analysis and interpretation to cross-functional teams and senior management
Independently write, review, and provide input on technical documents
Oversight and responsibility for leading the strategy as well as writing, when applicable, the key sections for periodic reports (e.g. DSURs, PADERs and Safety sections of the IBs)
Lead and set the strategy, in collaboration with the development medical lead of study protocols and informed consents
Responsible for implementing risk management strategies for assigned product
Proactively engaging, inspiring, coaching and mentoring team members 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
Qualifications:
MD / DO with 2+ years of internal medicine residency with patient management experience required; PhD is preferred in addition to MD / DO, not required5 - 8 years of Pharmacovigilance / Clinical Development experience in the pharmaceutical industry
Oncology experience and early development 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
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 Company's 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 committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies 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.
-
Medical Oncology Specialist
4 weeks ago
Chicago, Illinois, United States American Society of Clinical Oncology Full timeJoin Our Team as a Medical Oncology SpecialistWe are seeking a highly skilled Medical Oncology Specialist to join our team at the OSF HealthCare Cancer Institute. As a Medical Oncology Specialist, you will have the opportunity to build a subspecialized practice and work closely with experienced scientists and clinicians.Key Highlights:80% Clinical/20%...
-
Chicago, Illinois, United States AbbVie Full timeJob SummaryWe are seeking a highly skilled and experienced Senior Medical Director to lead our Oncology Clinical Development team. As a key member of our organization, you will be responsible for designing and implementing clinical development programs that drive innovation and deliver results.Key ResponsibilitiesLead and oversee the design and...
-
North Wales, Pennsylvania, United States Merck Full timeJob SummaryMerck is seeking a highly skilled Medical Director to lead the Oncology Asset Development Team. As a key member of our team, you will be responsible for planning and directing clinical research activities involving new Oncology medicines. Your expertise will be crucial in managing the entire cycle of clinical development, from study design to...
-
Director of Quality and Safety
3 weeks ago
Chicago, Illinois, United States University of Illinois at Chicago Full timeAbout the RoleThe University of Illinois at Chicago is seeking a highly skilled and experienced Director of Quality to join our Oncology Service Line team. As a key member of our leadership team, you will be responsible for overseeing and coordinating all aspects of quality improvement initiatives across the oncology care continuum.Key ResponsibilitiesLead...
-
Executive Medical Director, Hematology
5 months ago
North Chicago, United States AbbVie Full timeCompany 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...
-
Director of Quality and Safety
4 weeks ago
Chicago, Illinois, United States University of Illinois Full timeAbout the RoleWe are seeking a highly skilled and experienced Director of Quality to join our team at the University of Illinois Hospital and Health Sciences System. As a key member of our Oncology Service Line, you will be responsible for overseeing and coordinating all aspects of quality improvement initiatives across the oncology care continuum.Key...
-
Chicago, Illinois, United States AbbVie Full timeJob SummaryAbsorb the challenge of leading clinical development programs at AbbVie, a global leader in biopharmaceuticals. As a Senior Medical Director, Clinical Development, you will oversee the direction, planning, execution, and interpretation of clinical trials or research activities.Key ResponsibilitiesParticipate in cross-functional teams to generate,...
-
Chicago, Illinois, United States AbbVie Full timeJob SummaryAbbVie is seeking a highly experienced Senior Scientific Director to lead the clinical development of our oncology products. The successful candidate will have a strong background in clinical trial design, execution, and analysis, as well as excellent leadership and communication skills.Key ResponsibilitiesLead the development and implementation...
-
Chicago, Illinois, United States AbbVie Full timeJob DescriptionJob Title: Senior Medical Director, Clinical DevelopmentCompany: AbbVieLocation: Illinois (hybrid, 3x per week onsite)Job Type: Full-timeAbout Us: AbbVie is a global biopharmaceutical company dedicated to discovering and delivering innovative medicines and solutions that solve serious health issues.Job Summary: We are seeking a highly...
-
Chicago, Illinois, United States AbbVie Full timeJob SummaryAbbVie is seeking a highly skilled Medical Director Oncology Clinical Development to oversee the direction, planning, execution, and interpretation of clinical trials or research activities of a clinical development program. The successful candidate will participate in cross-functional teams to generate, deliver, and interpret high-quality...
-
Chicago, Illinois, United States Rush University System for Health Full timeGenitourinary Medical Oncology Clinical Faculty PositionRush University Medical Center, a nationally recognized clinical and academic institution, invites applications for the position of Genitourinary Medical Oncologist. The successful candidate will be board certified in medical oncology or hematology/oncology and have demonstrated interest and academic...
-
Director Patient Care
4 weeks ago
North Arlington, United States Clara Maass Medical Center Full timeJob Overview:RWJBarnabas Health is seeking a highly dedicated Clinical Director for our Medical/Surgical and Oncology Unit at Clara Maass Medical Center in Belleville, NJ. With over 700 physicians and 2,100 employees, we offer advanced treatment for a wide variety of medical conditions. In 2017, the Medical Center completed a state-of-the-art campus...
-
Director Patient Care
4 weeks ago
North Arlington, United States Clara Maass Medical Center Full timeJob Overview: RWJBarnabas Health is seeking a highly dedicated Clinical Director for our Medical/Surgical and Oncology Unit at Clara Maass Medical Center in Belleville, NJ. With over 700 physicians and 2,100 employees, we offer advanced treatment for a wide variety of medical conditions. In 2017, the Medical Center completed a state-of-the-art campus...
-
Senior Director of Clinical Development
6 days ago
Chicago, Illinois, United States AbbVie Full timeAbout the Role:The Senior Director of Clinical Development will provide statistical leadership for clinical development and life-cycle management strategies for assigned projects. This includes clinical trials, patient safety, and global medical affairs. The ideal candidate will work in partnership with experts in multiple disciplines to advance medicines to...
-
Chicago, Illinois, United States AbbVie Full timeJob OverviewAbbVie is seeking a highly skilled Medical Director to lead the clinical development of our oncology programs. As a key member of our team, you will be responsible for overseeing the direction, planning, execution, and interpretation of clinical trials or research activities.Key ResponsibilitiesManage and demonstrate ownership of the design and...
-
Chicago, Illinois, United States AbbVie Full timeJob Summary:We are seeking a highly skilled and experienced Senior Scientific Director to lead our Oncology Clinical Development Program. As a key member of our team, you will be responsible for directing the planning, execution, and interpretation of clinical trials and research activities.Key Responsibilities:Lead cross-functional teams to generate,...
-
Senior Medical Director, Product Safety Lead
1 week ago
Chicago, Illinois, United States AbbVie Full timeAbout the Role:Serve as Indication Product Safety Lead for one or more products or product indications under the direction of the Therapeutic Area (TA) Lead and Global TA.Ensuring safety of one or more products through the product lifecycle (e.g. surveillance, signal detection, validation and assessment). Interpreting regulations related to pharmacovigilance...
-
Medical Director of Oncology Services
1 day ago
Chicago, Illinois, United States The Curare Group Full timeThe Curare Group seeks an experienced medical director to lead our oncology services in Chicago, Illinois. As a chief of medical oncology, you will oversee the delivery of high-quality patient care at our free-standing oncology specialty hospital.Key responsibilities include:Leading a team of healthcare professionals to provide exceptional patient...
-
Chicago, Illinois, United States AbbVie Full timeJob SummaryAbbVie is seeking a highly skilled Medical Director to lead the clinical development of our oncology programs. The successful candidate will oversee the direction, planning, execution, and interpretation of clinical trials or research activities, working closely with cross-functional teams to generate, deliver, and interpret high-quality clinical...
-
Genitourinary Medical Oncology Faculty Position
4 weeks ago
Chicago, Illinois, United States Rush University System for Health Full timeGenitourinary Medical Oncology Clinical Faculty OpportunityRush University Medical Center, a leading academic and clinical institution, invites applications for a Genitourinary Medical Oncologist to join our team. As a board-certified medical oncologist or hematology/oncology specialist, you will be part of a growing multi-disciplinary urologic oncology...
