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19 days old

Biomarker Operations Specialist

Kelly Services
Lawrence, NJ 08648
Kelly Services is seeking a **Biomarker Operations Specialist** for one of our pharmaceutical clients in **Lawrenceville, NJ.**



Pay: negotiable



Duration:12 months



Summary/Scope

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



Education:

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.



Discretion/Latitude:

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




**Why Kelly** **** **?**



Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-01-06 Expires: 2021-02-25

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Biomarker Operations Specialist

Kelly Services
Lawrence, NJ 08648

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