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31 Dec 2020

Temporary Biomarker Operations Specialist (20-20946)

Axelon Services Corporation – Posted by Lawrence Township, New Jersey, United States

Job Description

“This role is currently work-from-home and will move to the office environment after the COVID-19 restrictions are lifted.”

Job Description: Translational Medicine at Client
Client is a leading global biopharma company focused on discovering, developing and delivering innovative medicines for patients with serious diseases. Our people are focused on helping millions of patients around the world in disease areas such as oncology, hematology, immunology, cardiovascular and neuroscience. We have built a sustainable pipeline of potential therapies and are leveraging translational medicine and data analytics to understand how we can deliver the right medicine to the right patient at the right time to achieve the best outcome.

Reporting to the Director, the Consultant will be part of the Immunology, Cardiovascular, and Fibrosis Translational Development Disease Team based in Princeton, NJ. The individual will support clinical biomarker activities to support drug development programs in Immunology and Fibrosis disease area. This individual will have the opportunity to guide and execute research projects through implementation of biomarker plan, data delivery and analysis of biomarkers in clinical studies. The successful candidate preferably will have knowledge in drug development process and biomarker assays, or prior experience in interacting with project teams, clinical research physicians, statisticians, computational biologists, contract research organizations and translational scientists to deliver science that supports the development of medicines to patients in need.

Responsibilities will include, but are not limited to, the following:

• Implements biomarker plan, develops in-depth understanding of clinical studies of assigned projects, manages the timelines and activities associated with biomarker data delivery such as setting up biomarker analysis request, following through projects with CRO, adapting with protocol amendment, tracking statistical analysis progress and generating detailed report of the biomarker analysis in parallel with clinical study progress
• Tracks availability of biomarker data and rapidly perform analyses of preliminary data.

• Performs literature research and synthesize/summarizes key points and concepts that are applicable to projects

• Implements translational activities through interaction with clinical team, statisticians, computational biologists and internal translational scientists
• Manages biomarker data delivery for clinical studies through working with relevant functions and CROs; responsible for aiding in creation of SOWs and interfacing with CRO for execution of services, in conjunction with Biospecimen Operations and Procurement.

• Evaluates CROs for data analysis and delivery capabilities, in conjunction with Translational Sciences and Precision Medicine
• Provides guidance on clinical biomarker data analysis to Global Biometrics, and Informatics and Predictive Sciences
• Maintaining timelines for biomarker data related publication through interaction with Medical Communications and Publication team
• Prepares and delivers presentations within the department and externally

Skills/Knowledge Required

• Understanding of drug development process
• Knowledge of the technologies for biomarker analysis
• Experience in interacting with CROs and KOLs to manage projects and timelines preferred
• Proven scientific/leadership expertise (working in teams, managing projects)
• Accountable for timelines and deliverables
• Prioritizes risks and implements contingency plans
• Communicates regularly; prepares and delivers presentations within the group and department
• Recognizes cross-functional issues and communicates within the larger organization. Has a track record of delivering results, driving continuous improvements, and building effective cross-functional networks.
• Ability to prioritize and manage time efficiently
• Strong verbal and written communication skills
• Accurate and detailed record keeping
• Excellent organizational skills

Ph.D., and 2+ years, Master and 10+ years of academic, biotechnology or pharmaceutical industry experience. Candidate must be a rigorous, detail-oriented scientist, with excellent record keeping and organizational skills. Must be a highly flexible, results oriented, independent self-starter who enjoys working in a fast-paced dynamic environment.

Functional/Scientific/Technical Skills:
• Contributing to research program and business.
• Skilled in using Excel, Graphpad, and Spotfire files (or similar analytical programs)
• Technical writing skills
• Experience in subject matter.
• Broad knowledge of multiple functional technologies.
• In-depth understanding of function as it relates to project.
• Functional area skills, theoretical knowledge and experience to apply scientific direction and approach to projects and problems.

Tasks and Responsibilities:
• Completes biomarker data generation related assignments by designing analysis and interpreting multi-parameter data readouts.
• Work on cross functional assignments and maintains timelines.
• Manages and/or coordinates workflow on biomarker projects.
• Ability to recognize, articulate, and accept calculated risks to make informed decisions
• Interpret results.

• Helps design biomarker analysis plan consistent with department goals.
• Provides input and makes recommendations to research strategies and publication plans.

Creativity and Problem Solving:
• Identify & solve multi-faceted challenges.
• Recognizes problems and is able to recommend and develop appropriate solutions from prior experience, literature, or collaboration.
• Identify risks.
• Contributes ideas and develops/presents a scientific case (or position) inside and outside department/group.

Teamwork and Influence:
• Communicates with cross functional team.
• Directly impacts the achievement of workgroup/team goals.
• Represents workgroup/team or department on multi-disciplinary or cross functional teams.

Organizational Impact:
• Direct impact on departmental performance.
• Impact is achieved by driving team efforts.
• Able to conceptualize broad impact of research programs

Behavioral Competencies:

• Strong sense of responsibility and ownership
• Agile, able to adapt to changes
• Lead/drive projects, networking with stake holders
• Provides recommendation/directions
• Thinks strategically

How to Apply

Please send your updated resume to

Job Types: Temporary.

Job expires in 68 days.

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