Biomarker Operations Specialist
Biomarker Operations Specialist
Job Number: 21-02326
Job Number: 21-02326
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Biomarker Operations Specialist for our client in Lawrence Township, NJ.
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
- Reporting to the Director, the Consultant will be part of the Immunology, Cardiovascular, and Fibrosis Translational Development Disease Team based.
- The individual will support clinical biomarker activities to support drug development programs in immunology and fibrosis.
- 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 prior experience 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 for patients with unmet needs.
- 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.
- 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 synthesizes/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
- Maintains timelines for biomarker data related publications through interaction with Medical Communications and Publication team
- Prepares and delivers presentations within the department and externally
- 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.
- Ph.D. and 2+ years, or Master of Science and 10+ years of academic, biotechnology or pharmaceutical industry experience
- 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.
- Understanding of drug development process
- Experience in interacting with CROs and KOLs to manage projects and timelines
- Proven scientific/leadership expertise (working in teams, managing projects)
- Accountable for timelines and deliverables
- Prioritizes risks and implements contingency plans
- Outstanding communication skills; 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.
- Experienced in a cross-matrixed organization
- Ability to prioritize and manage time efficiently
- Strong verbal and written communication skills
- Accurate and detailed record keeping
- Excellent organizational skills
- Functional/Scientific/Technical Skills:
- Contributes 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.
- Helps design biomarker analysis plan consistent with department goals.
- Provides input and makes recommendations to research strategies and publication plans.
- Creativity and Problem Solving:
- Identifies & solves multi-faceted challenges.
- Recognizes problems and is able to recommend and develop appropriate solutions from prior experience, literature, or collaboration.
- Identifies risks and develops mitigation plans.
- 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
If hired, you will enjoy the following Eclaro Benefits:
- 401k Retirement Savings Plan administered by Merrill Lynch
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
If interested, you may contact:
Jay Lucas | LinkedIn
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.