Senior Biomarker Program Manager
Senior Biomarker Program Manager
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1 Vacancy
Job Description
AbbVie strongly believes in the importance of identifying patients who are most likely to benefit from the medicines that they develop and commercialize. To this end AbbVie has established and expanded core capabilities in Precision Medicine (PMed) encompassing clinical trial management translational medicine and companion diagnostics. Within PMed the Biomarker Program Management (BPM) team connects science and operations to manage biomarker research for multiple Phase 13 clinical trials. We are seeking an experienced and highly motivated individual who will employ operational and logistical strategies to ensure clinical trials are executed with quality and efficiency ontime within budget and meet objectives. The successful candidate will have a proven track record of clinical trial experience and decisionmaking to achieve these objectives including scientific expertise strategic thinking a patientoriented mindset team building and crossfunctional collaboration.
Responsibilities:
- Manage biomarker operations and logistics to support the clinical trial schedule ensuring data are ready for analysis per timeline. Resolve or escalate biomarker studyrelated issues with PMed Lead or BPM Subject Matter Expert (SME).
- Responsible for relevant biomarker content in clinical study documents and associated systems (including clinical trial blueprint/protocol informed consent forms eCRFs CSRs etc). Responsible for generating study related training materials for the study team study sites and vendors for each trial. Ensure consistency across programs.
- Manage EC/IRB biomarker related inquiries ensuring consistent responses across studies while maintaining AbbVie biomarker standard language and study timelines. Work with nonPMed areas to improve crossfunctional processes.
- Manage biomarker vendor selection and scope managing contract execution and vendor oversight in compliance with AbbVies procedures and applicable regulations. Work with Contracting Procurement or other AbbVie resources to improve contracting efficiency and reduce costs across PMed.
- Responsible for the accurate forecasting and tracking of study costs associated with sample and results management bioanalytical assays logistics and shipping.
- Identify and resolve and/or escalate studyrelated issues and risks. Assist other team members to resolve risks.
- Conceive and spearhead efforts to improve processes within and external to PMed. Responsible for ensuring BPM training materials are current. Lead training for new PMed members for some sections of the Process Guides.
- Oversee sample analysis and data transfer tasks ensuring timely sample shipments to vendors and/or storage sites and that the data are transferred to the correct databases. Oversee sample management storage and/or destruction per requirements. May work with or manage a Sample Operations Manager with responsibility for these tasks.
- Understand and ensure the biomarker strategy is implemented in trial documents and processes.
- Apply and adhere to ICH/GCP biorepository procedures biosample management best practices and ethical guidelines. Ensure appropriate documents are added to the Trial Master File.
- Provide leadership and mentoring for team members; responsible for developing the expertise of team members. May manage contract or FTE as needed. Set a positive and motivating work environment that encourages mutual respect innovation and accountability at all levels. Balance multiple priorities in a fastpaced teambased environment and set priorities for self and reports per Department needs.
Qualifications :
- BS MS or Ph.D. Degree with 4 (Ph.D.) 9 (MS) or 12 (BS) years of project management clinical trial experience and biological science background including biomarkers.
- Proven track record of clinical trial and project management experience; proven ability to work well on teams.
- Excellent oral and written communications skills in English. Expertise in MS Office applications including Excel Word and PowerPoint.
- Organization attention to detail and effective time management with an ability to adapt to changing priorities. Excellent analytical and interpersonal skills. Experience interacting with various levels within the organization as well as vendors.
- Demonstrated ability to run meetings work collaboratively in a crossfunctional environment and drive for success.
- Experience with and/or willingness to manage and mentor direct report(s).
- Scientific knowledge of the therapeutic area to be supported a plus.
- Project Management certification preferred.
- Ability to work in a fastpaced complex environment with minimal supervision.
Additional Information :
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our shortterm incentive programs.
This job is eligible to participate in our longterm incentive programs
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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable 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.
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Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
