AbbVie

Program Manager, Biomarker

Employer
AbbVie
Location
Redwood City, CA, United States
Posted
Sep 16, 2020
Ref
2006831
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 .

Purpose:
The Translational Oncology group at AbbVie uses advanced methods to discover biomarkers and implement translational strategies to further AbbVie's innovative Oncology pipeline. The Biomarker Program Manager connects science and operations to manage biomarker research for an oncology program (multiple Phase 1-3 clinical trials) while providing leadership on the Biomarker Program Management 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 support the clinical trial schedule. Proactively identify and resolve, and/or escalate biomarker study-related issues
  • Co-manage with lead biomarker scientist to provide regular updates to cross-functional stakeholders for each program
  • Key creator of relevant biomarker sections in clinical study documents and associated systems (including trial blueprint/protocol, informed consent forms, eCRFs, CSRs, etc.) o Manage EC/IRB biomarker related inquiries, ensuring consistent responses across studies while maintaining AbbVie biomarker standard language and study timelines. o Responsible for generating study related training materials for the study team, study sites and vendors for each trial o Ensure appropriate documentation of
  • Co-manage biomarker vendor selection and research scope; manage contract execution and vendor oversight in compliance with AbbVie's procedures and applicable regulations o 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
  • 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 Translational Oncology, as needed
  • Spearhead and participate in process improvement initiatives and improving efficiency as needed
  • 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 project management, oncology and/or clinical trial experience or Master's Degree with 8+ years project management, oncology and/or clinical trial experience or Bachelor's Degree with 10+ years of project management, oncology and/or clinical trial experience
  • 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 a plus. PgMP certification 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 oncology. Exposure to companion diagnostic development.
  • Experience working in a quality control and regulatory-rich environment. Experience holding meetings by teleconference and working with colleagues remotely


Significant Work Activities
N/A
Travel
No
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.