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Manager, Companion Diagnostic Operations
3 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 Follow @abbvie onTwitter,Facebook,Instagram,YouTubeandLinkedIn.
Job Description
AbbVie is currently offering a unique opportunity for a highly motivated individual to join our Precision Medicine team as a Manager, Companion Diagnostics Operations. The CDx Operations Manager will work closely with CDx Strategy Leads and other clinical development team members to facilitate science-based CDx decision making and support the execution of CDx development strategy for AbbVie programs across therapeutic areas. The successful candidate will have experience in facilitating therapeutic product and/or CDx co-development, project management, scenario planning, budgeting, and managing external vendors and partners. This role must be based on site at our Waltham, MA office.
Responsibilities
Drive the implementation of the clinical diagnostic strategy for therapeutic programs in early and late stage oncology clinical development.Lead and coordinate resources from multiple functional areas (Biomarker research, Regulatory, Pathology, Clinical Science, Biosample Management, Clinical Operations and Medical Affairs)Manage activities and tech transfers across various AbbVie sites for CDx programsand understand cost drivers associated with contract types and drive negotiations that ensure the best value for quality, pricing, and service.The liaison for CDx and external CROs, oversee the CRO/diagnostic partnering transfer activities with functional area leads.Oversee implementation of clinical trial assays at reference labs and centralized testing vendors. Monitors all changes in study scope ensuring timely finalization and implementation; including the negotiation of change order costs for impacted agreements.Responsible for communication of status of negotiations with key internal and external stakeholders in a timely manner.Accountable for all activities involving start-up execution and close-out of all contracts, budgets and time-lines. Demonstrates a high level of outsourcing and technical competencies across multiple contract types and therapeutic/functional areas. Highly competent in negotiation and contracting business standards. Acts as the first line contact for issue escalation related to contracts
Qualifications
BS or equivalent education and extensive, typically 5+ years of relevant experience; MS or equivalent education with typically 3+ years of relevant experience; PhD with typically 1+ years of relevant experience in pharmaceutical and/or diagnostics companies.Experience managing Biomarker and/or CDx aspects of early and late stage clinical programs including sample management, working with CROs and Diagnostic partnersExperience managing budgets, creating RFP/RFIs, and reviewing proposals/contracts from external vendorsExperience with the development and validation of clinically applicable diagnostic assays, and/or clinical validation and launch of companion diagnosticsExcellent verbal communication and interpersonal skills are requiredStrong motivation, attention to detail, ability to think independently and fully integrate into a high achieving team environment.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law: The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees. This job is eligible to participate in our short-term incentiveprograms. This job is eligible to participate in our long-term incentiveprograms Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable law. AbbVie is an equal opportunity employer and 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. US & Puerto Rico only - to learn more, visit
