AbbVie

Biomarker Program Manager I

Employer
AbbVie
Location
South San Francisco, California
Posted
Sep 18, 2021
Ref
2114277
Required Education
Bachelors Degree
Position Type
Contract
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.

There is an exciting opportunity within the Precision Medicine Operations group at AbbVie.  The Precision Medicine 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 biopharmaceutical pipeline. AbbVie is hiring a Biomarker Project Manager I who will implement and then manage biomarker related information 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.

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
  • Responsible for 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
  • Manage 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
  • Oversee sample analysis and data transfer; ensure timely shipments to vendors and/or storage sites and that the data are transferred to correct databases
  • 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.  Update 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:

  • PhD degree with 2+ years project management, clinical trial experience and biological science background, including biomarkers.
  • Master’s Degree with 7+ years project management, clinical trial experience and biological science background, including biomarkers.
  • Bachelor’s Degree with 10+ years of project management, clinical trial experience and biological science background, including biomarkers.
  • 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.  Proven ability to work well on teams.

Preferred:

  • 2+ years direct clinical/biomarker operation 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
  • Project Management certification a plus

 
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 operations, Precision Medicine, oncology, clinical operations, project management

 

 

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


Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 5 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
M
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.