AbbVie

Biomarker Program Manager

Employer
AbbVie
Location
South San Francisco, CA, United States
Posted
Feb 20, 2021
Ref
2009694
Required Education
Doctorate/PHD/MD
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 .

POSITION DESCRIPTION:

There is an exciting opportunity in the Precision Medicine 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 biotherapeutic pipeline. AbbVie is hiring a Biomarker Program Manager who will connect science and operations to implement then manage biomarker research for an immunology program (multiple phase 1-3 clinical trials) while providing leadership on the Biomarker Program Management (BPM) team. This role employs operational and logistical strategies to ensure clinical trials are executed with quality and efficiency, on-time, within budget, and meet objectives. The program manager achieves these objectives via scientific expertise, strategic thinking, a global mindset, team building and cross-functional collaboration.

RESPONSIBILITIES:

 

  • Manage biomarker operations and logistics to align with the clinical trial schedule. Proactively identify and resolve, and/or escalate biomarker study-related issues
  • Co-manage with lead biomarker scientist to provide regular update to cross-functional stakeholders for each program
  • Create relevant biomarker sections in 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
  • Co-manage biomarker vendor selection and research scope; manage contract execution and vendor oversight in compliance with AbbVie's 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
  • Manage sample analysis and data transfer; ensure timely sample shipments to vendors, and/or storage sites, and that the data are transferred to correct databases. Oversee sample management storage, and/or destruction per requirements
  • Responsible for generating study related training for the study team, study sites and vendors for each trial
  • Apply and adhere to ICH/GCP, biorepository procedures, biosample management best practices and ethical guidelines.
  • Serve as a subject matter expert (SME) and owner for one or more processes in BPM
  • Create or revise standard operating procedures, work instructions and job aids for Immunology as needed
  • Spearhead and participate in process improvement initiatives and improving efficiency as needed as well as instructions and manuals for internal training purposes
  • Provide leadership and mentoring for team members; responsible for developing the expertise of team members.
  • Manage contract or permanent employees 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 work independently.


Qualifications

 

 

  • Ph.D. Degree with 4+ years of project management, immunology including clinical trial experience OR Master's Degree with 8+ years of project management, immunology including clinical trial experience OR Bachelor's Degree with 10+years of project management, immunology and clinical trial experience
  • Experience in managing clinical and biomarker operations
  • Excellent oral and written communication skills in English. Expertise in MS Office applications including Excel, Word, and PowerPoint
  • Organization, attention to details, 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.
  • Proven success in running meetings, working collaboratively in a cross-functional environment, and driving for success
  • Experience managing and mentoring direct reports
  • PMP certification and/or PgMP certification is a plus
  • Competent in application of standard business procedures (Standard Operating Procedures, International Conference on Harmonization {ICH}, Global Regulations, Ethics and Compliance)
  • Scientific background in and knowledge of immunology. Exposure to companion diagnostic environment. Familiarity with oncology and/or neurology is a plus.
  • Experience working in a quality control and regulatory-rich environment. Experience holding meetings by teleconference and working with colleagues remotely


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


Key Words: Clinical Trials, Clinical Operations, Biomarkers, Immunology, Program Manager, Project Manager, Team Leadership

**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.