Manager / Senior Manager, Companion Diagnostics

Employer
AbbVie
Location
South San Francisco, California, USA
Posted
Apr 14, 2018
Ref
1802817
Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products — Imbruvica, Venclexta, and Empliciti — and a pipeline containing multiple promising new molecules that are being studied in nearly 200 clinical trials in 19 different types of cancer.

AbbVie is expanding its oncology hub on the West Coast, with three sites in the San Francisco Bay Area (Redwood City, South San Francisco, and Sunnyvale) focused the discovery and development of novel oncology therapies. More than 1,000 AbbVie scientists, clinicians, and product developers with strong entrepreneurial roots wor across these three sites. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. This position is based at Stemcentrx, AbbVie's South San Francisco, CA location.

Specific Job Requirements:

We are seeking a creative and highly motivated scientist to be responsible for the oversight and execution of companion diagnostic (CDx) development and launch readiness strategies. The Senior CDx Manger will facilitate science-based CDx decision making, maintaining focus on innovative products and new diagnostic partners with the potential to transform therapeutic areas. The successful candidate will have experience synthesizing and facilitating key discussions on therapeutic product and CDx co-development, project strategy, TPPs, scenario planning, valuation, and cost.

Essential Duties and Job Functions:

Drive the implementation of the clinical diagnostic strategy for multiple therapeutic programs in early and late stage oncology clinical development

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 programs

Serve as the liaison for Clinical Biomarker assay and CDx 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

Manage the development of monoclonal reagents with multiple tissue diagnostic partners

Manage contracts, budgets and time-lines

Draft regulatory documents for biomarker and CDx to enable prospective analysis in phase 1 and phase 2 studies, including investigational use of candidate companion diagnostic (pre-IVD) assays.

Maintain knowledge of applicable regulatory requirements and scientific/technical issues relevant to assigned projects.

Position will be filled at a level commensurate with experience.
  • BS or equivalent education and typically 8 years of pharma/clinical research-related experience. Must have CDx expertise in oncology.
  • Experience with the discovery, characterization, clinical validation and launch of companion diagnostics
  • Experience in development, outsourcing and validation of clinically applicable BM and CDx assays
  • Excellent verbal communication and interpersonal skills are required
  • Strong motivation, attention to detail, ability to think independently and fully integrate into a high achieving team environment
  • Must be able to articulate risks and identify opportunities while fostering team culture and valuing diverse viewpoints.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled