AbbVie Biomarker Program Manager Vacancy – Biological Science
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.
Job Title: Biomarker Program Manager III
Location: Lake County, United States of America; South San Francisco, United States of America
Department: Research and Development
Job id: 2114277
Elibgility Criteria:
- Ph.D. degree with 2+ years of projects 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 detail, 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 the 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
Responsibilties:
- Manage the biomarker operations and logistics to align with the 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 improve 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
AbbVie Biomarker Program Manager