Associate Director, Companion Diagnostics Strategy Lead

BioSpace; North Chicago (IL); On-site; USD 180,000 - 240,000; Full time

Job summary

AbbVie seeks an Associate Director, Companion Diagnostics Strategy Lead to advance global diagnostic strategies supporting CDx development across oncology, immunology, and neuroscience. You will work in a highly collaborative, multidisciplinary setting and guide co-development with external partners to meet project timelines.

The role emphasizes leadership, deep biomarker knowledge, regulatory savvy, and strong communication to enable global development and commercialization of targeted

Qualifications

• PhD in science or related field with 8+ years of experience.
• Experience in technical and regulatory aspects companion diagnostic development.
• Cross-functional experience in commercial and/or medical aspects of companion diagnostics is a plus.
• Demonstrated excellence in independently leading and conducting research and ability to evaluate, interpret and present complex scientific data.
• Experience in human translational research with biomarker application in clinical trials and awareness of challenges implementing diagnostic technologies in clinical settings.

Responsibilities

• Lead the development and implementation of diagnostic strategies for individual projects and/or therapeutic areas.
• Direct the development, outsourcing and validation of clinically applicable companion diagnostic assays for FIH and registrational studies.
• Design, implement and oversee diagnostic testing and data analysis.
• Provide expertise to development project teams to ensure access to state-of-the-art diagnostic thinking and validation status.
• Lead joint development teams between AbbVie and Dx partners to ensure fit-for-purpose CDx development and timelines.
• Serve as SME in biomarker testing technologies (IHC, FISH, NGS, PCR, flow cytometry).
• Lead interactions with global health authorities regarding CDx development and submissions.

Skills

CDx development

Biomarker testing

Immunohistochemistry

FISH

NGS

PCR

Flow cytometry

Cross-functional leadership

Scientific data analysis

English communication

Education

PhD in Science or related field

Job description

About AbbVie

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. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Description

AbbVie is offering a unique opportunity for a highly motivated individual to join our team as an Associate Director, Companion Diagnostics Strategy Lead within the Precision Medicine Companion Diagnostics team, which supports CDx development across therapeutic areas (oncology/immunology/neuroscience). We are seeking a creative and highly motivated leader to develop and implement global diagnostic strategies to enable and support the global development and commercialization of innovative targeted therapies. The successful candidate will have the opportunity to work in a highly collaborative environment and will be a key member of multidisciplinary development project teams.

Essential Duties And Job Functions

• Lead the development and implementation of diagnostic strategies for individual projects and/or therapeutic areas
• Direct the development, outsourcing and validation of clinically applicable companion diagnostic assays for FIH and registrational studies
• Design, implement and oversee diagnostic testing and data analysis
• Provide expertise to development project teams to ensure access to state-of-the art thinking on appropriate diagnostic technologies, evaluating their scientific basis and clinical applicability, the validation status and any technical or statistical issues related to the proposed companion diagnostic assay
• Lead joint development teams between AbbVie and Dx partners to ensure successful fit for purpose CDx development and that co-development timelines are met
• Serve as subject matter expert in state-of-the-art biomarker testing technologies (immunohistochemistry, FISH, NGS, PCR, flow cytometry, etc)
• Will lead interactions with global health authorities regarding companion diagnostics development and submissions

While the ideal work location will be based out of AbbVie's HQ in IL, candidates can also be based out of AbbVie's Waltham, MA location.

Qualifications

• PhD in Science or related field with 8+ years of related work experience.
• Experience and knowledge in the technical and regulatory aspects companion diagnostic development
• Cross-functional experience in commercial and or medical aspects of companion diagnostics is a plus
• Demonstrated excellence in independently leading and conducting research and ability to evaluate, interpret and present complex scientific data
• Experience in human translational research with biomarker application in clinical trials and awareness of the challenges of implementing diagnostic technologies in the clinical setting is desirable
• Excellent leadership skills including motivation and influencing without authority
• Excellent verbal and written communication and presentation skills in English
• High level of initiative and ability to work independently
• High level of business awareness
• Experience in Oncology therapeutic area is a PLUS

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, andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin 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 toparticipatein 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 employeeremainsin the Company's sole andabsolutediscretion unless and until paid andmay bemodifiedat 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 and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html