AbbVie

Project Manager I, Biomarkers

Employer
AbbVie
Location
Redwood City, CA, United States
Posted
Nov 20, 2020
Ref
2008837
Required Education
Masters Degree/MBA
Position Type
Full time
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines 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, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

JOB DESCRIPTION:

There is an exciting opportunity within the Precision Medicine Oncology group at AbbVie. The Precision Medicine Oncology group uses advanced methods to discover biomarkers for use in clinical trials. Biomarkers may be used to confirm the molecular targets of a drug, predict efficacy, aid in patient selection and/or inform future drug development strategies. Biomarker research is an essential component for helping serve patient needs and furthering AbbVie's innovative Oncology pipeline. AbbVie is hiring a Biomarker Project Manager I who will connect science and operations to implement and then manage biomarker research in multiple Phase 1-3 clinical trials. This role will employ operational and logistical strategies ensuring clinical trials are executed with quality and efficiency, on-time, within budget, and meet objectives. The project manager achieves these objectives via scientific expertise, strategic thinking, a global mindset and cross-functional collaboration.

RESPONSIBILITIES:
  • Manage the biomarker operations and logistics to align with clinical trial schedule
  • Co-manage with lead biomarker scientist to support regular updates to cross-functional stakeholders for each trial
  • Key contributor of relevant clinical study documents and associated systems (including trial blueprint/protocol, Informed consent forms, eCRFs, CSRs, etc.)
  • Oversee EC/IRB biomarker related inquiries, ensuring consistent responses across studies while maintaining AbbVie biomarker standard language and study timelines
  • Support biomarker vendor selection and research scope; manage contract execution and vendor oversight in compliance with AbbVie's processes, procedures and applicable regulations
  • Responsible for the accurate forecasting and tracking of study costs associated with sample and result management, bioanalytical assays, logistics and shipping as needed
  • Responsible for generating study related training for the study team, study sites and vendors for each trial
  • Coordinate sample analysis and data transfer; ensure timely shipments to vendors and/or storage sites and that the data are transferred to correct databases
  • Responsible for sample management, storage, and/or destruction per requirements
  • Deposit biomarker related documents to the Trial Master File, ensuring that documentation standards are followed and are 'inspection-ready'
  • Proactively identify and resolve and/or escalate study-related issues
  • Apply and adhere to ICH/GCP, bio-storage procedures, bio-sample management best practices and ethical guidelines Serve as a subject matter expert (SME) and resource for one or more processes in BPM
  • Spearhead or participate in process improvement initiatives or improving efficiency as needed, as well as instructions and manuals for internal training purposes
  • Manage multiple contract or permanent employees if needed
  • Contribute to 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 work independently when needed

Qualifications

QUALIFICATIONS:
Required:

  • Master's Degree with 4+ years project management, oncology and/or clinical trial experience
  • Bachelor's Degree with 6+ years of project management, oncology and/or clinical trial experience
  • Expertise in MS Office applications including Excel, Word and PowerPoint
  • Excellent oral and written communication skills in English
  • Organization, attention to details and effective time management with an ability to adapt to changing priorities; excellent analytical and interpersonal skills

Preferred:
  • PMP certification a plus
  • Minimum 2+ years direct clinical trial management experience, with exposure spanning initiation through study completion preferred
  • Competent in application of standard business procedures (standard operating procedures, International Conference on Harmonization {ICH}, Global Regulations, Ethics and Compliance)
  • Scientific background in biology or related. Knowledge of oncology is desirable
  • Ability to work with minimal supervision
  • Experience holding meetings by teleconference and working with colleagues remotely
  • Effectively work in a cross-functional team environment and ability to interact with various levels within the organization as well as vendors


Key Leadership Competencies:
  • Builds strong relationships with peers and cross-functionally with partners outside of team
  • Learns fast, grasps the "essence" and can change course quickly when required
  • Raises the bar and is never satisfied with the status quo
  • Creates a learning environment, open to suggestions and experimentation for improvement
  • Embraces the ideas of others, nurtures innovation


Keywords: Biomarker, oncology, project management, clinical trial management, companion diagnostic, CDx, operations, design control

**Equal Opportunity Employer Minorities/Women/Veterans/Disabled**

Significant Work Activities
Awkward/forceful/repetitive motions (arms above shoulders, bent wrists, etc.)
Travel
Yes, 5 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
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.