Biomarker Associate I
Pharmacyclics is committed to the development and commercialization of novel therapies intended to improve the quality and duration of life and to resolve serious unmet medical needs for cancer patients. Pharmacyclics is a wholly-owned subsidiary of AbbVie (NYSE:ABBV), a global, research-based biopharmaceutical company. Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products and a pipeline containing multiple promising new molecules that are being studied in more than 200 clinical trials for over 20 different types of cancer.
More than 1,200 Pharmacyclics and AbbVie research scientists, clinicians, marketing, operations and corporate professionals work in the San Francisco Bay Area. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. Together, we are striving to outsmart cancer.
To learn more about us, please visit us at http://www.pharmacyclics.com/
Pharmacyclics is seeking a Biomarker Associate I.
General Position Summary/Purpose:
Works closely with clinical operations, project managers and laboratory managers to ensure timely and smooth collection, transfer of clinical trial bio-specimens and ensures compliance with protocols, regulatory requirements, and project timelines. Identifies projects/tasks together with laboratory managers and liaisons with Clinical Operation study management teams to complete tasks. Contributes to innovation and continuous improvement activities in bio-sample collection, processing, and transfers. Demonstrates ability to carry out all B io-Sample management functions with minimal supervision.
Key Accountabilities/Core Job Responsibilities:
- Track Clinical and laboratory samples and follows up with sites/study team and or CRO to resolve queries: data entry and reconciliation when needed.
- Develops ability to organize and manage large datasets and present regular summaries to team.
- Manage clinical bio-samples and storage equipment, including LN2 freezers at Pharmacyclics.
- In partnership with Clinical Operations, Discovery, CQA and IT, contribute to the development and efficiency of a LIMS for Pharmacyclics studies.
- Plan, organize and oversee the collection and shipping of bio-samples from investigator sites or centralized locations and subsequent delivery to analytical laboratories or Pharmacyclics. Partner with Biomarker Leads to ensure the delivery of bio-sample data in accordance with study timelines.
- Manage relationships with laboratory vendors, provide input into trial-specific agreements and assess service level commitments of labs involved in sample analysis. Ensure issues are resolved or escalated in a timely manner.
- Assist to review laboratory vendor invoices to ensure appropriate work has been completed.
- Contributes to functional process and system improvements to ensure samples are collected, processed, and analyzed appropriately.
- Participate in the review of SOPs and working practices.
- Develops independence in performing routine work and develops leadership skills.
- Apply and adhere to ICH/ GCP, biobanking policies, bio-sample management best practices, and ethical guidelines.
- Contributes to a positive and motivating work environment that encourages mutual respect, innovation and accountability at all levels.
- BA/BS in Biology, Pharmacology or equivalent, with/or 2+ years relevant industry experience . Experience in clinical research or bio-sample handling at either an investigational site, pharmaceutical/biotech company, or equivalent
- Proficiency in MS office including Word, Excel, PowerPoint and other applications.
- Previous experience and proficiency in utilizing LIMS preferred.
- Effective team player and ability to collaborate with cross functional clinical study teams.
- Ability to oversee bio-sample management activities across multiple clinical trials.
- Demonstrated ability to balance multiple priorities in a fast paced, team-based environment and work independently when necessary.
- Excellent written and interpersonal communication skills necessary to interface with outside vendors, consultants, and team members.
- Hands-on experience in handling clinical biological samples.
- Demonstrated strengths in planning, organizational, analytical skills, time management, problem solving, and attention to detail.