Job Title : Senior Manager, Precision Medicine Companion Diagnostics Operations

Purpose:

Describes the primary goals,objective or function or outputs of this position.

AbbVie is currently offering a unique opportunity for a highly motivated individual to join our Precision Medicine team as a Senior Manager, Companion Diagnostics Operations. The CDx Operations Senior 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.

Responsibilities:

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

• Drive the execution of the global clinical diagnostic strategy for therapeutic programs in early and late-stage clinical development
• Coordinate CDx operational activities with multiple functional areas (Biomarker Research, Regulatory, Pathology, Clinical Science, Biosample Management, Clinical Operations, and Medical Affairs)
• Serve as the liaison for CDx Partners and CROs.
• Oversee the CRO/diagnostic partnering transfer activities with functional area leads
• Manage activities and tech transfers across various AbbVie sites and CRO laboratories for CDx programs
• Oversee implementation of clinical trial assays at reference labs and centralized testing vendors
• Manage contracts, budgets and timelines.

Qualifications :

List required and preferred qualifications up to 10). Include education, skills and experience.

• BS or equivalent education and extensive, typically 7+ years of relevant experience; MS or equivalent education with typically 5+ years of relevant experience; PhD with typically 3+ 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 partners
• Experience managing budgets, creating RFP/RFIs, and reviewing proposals/contracts from external vendors
• Experience with the development and validation of clinically applicable diagnostic assays, and/or clinical validation and launch of companion diagnostics
• 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.

Key Stakeholders: Precision Medicine (CDx Strategy Leads), Pathology, Precision Medicine Leads), External Partners, Vendors and Finance

California requisition/job postings:  

Applicable to California Applicants Only 

• The below range is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range and this range is only applicable for jobs to be performed in California. This range may be modified in the future. 

• The salary range for this role is posted below 

• This job is eligible to participate in our short-term incentive program 

• This job is eligible to participate in our long-term incentive programs 

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. 

• 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 discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law. 

AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s 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 disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.