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Associate Director, Molecular Assays CDx Pathology


This is a Contract position in South San Francisco, CA posted June 12, 2020.

About AbbVie AbbVie (NYSE:ABBV) is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions.

The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience.

In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world.

For more information about AbbVie, please visit us at .

Follow abbvie on Twitter, Facebook or LinkedIn .

The Companion Diagnostics Pathology Group resides within the Companion Diagnostics Center of Excellence (CDx COE), which supports CDx development across AbbVie.

The role will work within the CDx COE Pathology Group to develop and implement nucleic acid based diagnostic assays to enable and support the development and commercialization of medically-differentiated therapies in oncology.

The Associate Director will be responsible for the design, implementation and oversight of nucleic acid based biomarker and diagnostic testing and data analysis for clinical studies.

The Associate Director will also evaluate the clinical applicability, validation status and scientific, technical or statistical issues related to nucleic acid based CDx techologies’ implementation.

He/she will provide help and scientific advice related to CDx sample collection, storage and sample and data analysis to other functions (e.g.

Contracts, Clinical Operations, Data Management, etc.

Responsibilities : Develops, validates and implements nucleic acid based diagnostic assays for individual projects and/or therapeutic areas, including generation of data characterizing the candidate diagnostic biomarker expression in multiple sample matrices by multiple orthogonal methods.

Acts as a subject matter expert within the Molecular Pathology Group for nucleic acid-based technologies and provides technical expertise to project teams on diagnostic technologies,evaluating their scientific basis, the validation status and any technical or statistical issues related to the proposed companion diagnostics.

Collaborates with biostatistics and bioinformatics to design and execute data analysis plans.

Supports the development, outsourcing, and validation of clinically applicable diagnostic biomarker assays.

Supports the co-development, outsourcing and validation of Companion Diagnostics Qualifications PhD in Molecular Biology, Cancer Biology, Cell Biology or a related field and a minimum of 5 years of relevant experience in a pharmaceutical, diagnostic or biotech environment or Master’s Degre with 10 years of relevant work experience Strong, hands-on experience with nucleic acid-based assay development encompassing both single gene and multiplexed assay formats, including PCR/qRT-PCR and NGS platforms Strong familiarity with bioinformatics tools for sequence analysis/alignment, and high content data analysis Familiarity with bioinformatics programming languages such as R is beneficial Familiarity with common laboratory techniques such as cell culture, western blotting, and immuneassay development is beneficial Experience in managing and/or mentoring individuals in a laboratory setting is beneficial Experience with the discovery, characterization, clinical validation and utilization of biomarkers and potential companion diagnostics Excellent verbal communication skills are required including the demonstrated ability to effectively and clearly summarize results for presentation and report generation Must be able to multi-task and work effectively within a team environment Strong motivation, attention to detail, ability to think independently and fully integrate into a high achieving team environment Preferred hands-on experience with IVD assay development process Preferred experience working in a regulated environment (CAP/CLIA/GCP) Significant Work Activities N/A Travel No Job Type Experienced Schedule Full-time Job Level Code M Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients.

As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.