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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. 

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 1-3 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, on-time, within budget, and meet objectives. The successful candidate will have a proven track record of clinical trial experience and decision-making to achieve these objectives, including scientific expertise, strategic thinking, a patient-oriented mindset, team building and cross-functional collaboration.

This position offers the flexibility to work onsite for a minimum of three days a week in Waltham, MA.

Responsibilities:

• Manage biomarker operations and logistics to support the clinical trial schedule, ensuring data are ready for analysis per timeline. Resolve or escalate biomarker study-related 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 non-PMed areas to improve cross-functional processes.
• Manage biomarker vendor selection and scope, managing contract execution and vendor oversight in compliance with AbbVie’s 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 study-related 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 fast-paced, team-based environment and set priorities for self and reports per Department needs.

Qualifications:

• BS, MS or Ph.D. Degree with 0-4+ (Ph.D.), 4-9+ (MS), or 6-12+ (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 cross-functional environment and drive for success.
• Experience with and/or willingness to manage and/or mentor direct report(s).
• Scientific knowledge of the therapeutic area to be supported, a plus.
• Project Management certification preferred.
• Ability to work in a fast-paced, complex environment with minimal supervision.

Position will be filled at level commensurate with extent of education, experience, and accomplishment. Biomarker Program Manager I,  Biomarker Program Manager II, Biomarker Program Manager III, or Senior Biomarker Program Manager.

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

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• 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 short-term incentive programs. ​

  
  

• This job may be eligible to participate in our long-term incentive programs​.

  
  

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

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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 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 protected veteran, or any other legally protected group status.

US & Puerto Rico only - to learn more, visit https://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