Merck Sharp & Dohme
Senior Scientist, Biomarker Operations, Project Management
Merck Sharp & Dohme, Rahway, New Jersey, us, 07065
Job Description
We are currently seeking a Senior Scientist within the Integrated Biomarker Operations organization to provide biomarker project management and operational expertise to support cross-functional clinical teams, ensuring the timely and efficient delivery of the biomarker operational aspects of each study.
This position will report into the Associate Principal Scientist of Project Management and be based either at Rahway, NJ, Upper Gwynedd, PA, San Francisco, CA, or Boston, MA site.
You will have experience in clinical biomarker assay execution and demonstrated success in project management. As a key contributor to the clinical biomarker strategy, you will be accountable for planning, implementation, and execution of clinical biomarker specimen collection, testing, and data delivery activities in clinical studies. The primary focus of this position is in oncology, although support of other disease areas may be required as therapeutic focus evolves.
The successful candidate will work closely with Biomarker leads, Assay scientists, Vendor Managers, and Clinical team to ensure that critical timelines are met by our vendors. You will also monitor Integrated Biomarker Operations processes, identify opportunities for improvement, and implement strategic solutions to ensure excellence in service delivery.
The selected candidate will have strong verbal and written communication skills and be expected to work independently in a highly collaborative and matrixed environment. You will excel under fast-paced and fluid conditions and be a strong advocate for operational excellence.
Primary responsibilities include, but are not limited to:
Collaborate closely with biomarker scientists and project teams to plan clinical trial biomarker set-up using logistical strategies to ensure efficient trial execution.
Be the operational partner to the Biomarker scientific leads to aid in implementing strategies that drive the biomarker program forward.
Participate as a co-author for drafting relevant biomarker sections of clinical study protocol.
Work closely with Translational Molecular Biomarker (TMB) Scientist to manage specimen collection, handling, shipping, and storage guidelines that align with the Biomarker plan and clinical study protocol.
Accountable for providing biomarker vendor assay statement of work and data transfer specifications to the clinical teams.
Work with data management to effectively transfer biomarker data to clinical data repository from external biomarker vendors.
Work with Clinical team and/or Central labs to design sample collection kits, laboratory manual, and specimen logistics for shipments to third party vendors.
Maintain and grow effective partnerships with external biomarker vendors and our Company's internal teams.
Coordinate sample and assay logistics and serve as a key point of contact with vendors/collaborators for timeline tracking, issue resolution, and risk mitigation.
Skills and Knowledge:
Well organized and methodical approach to problem solving.
Ability to understand and resolve conflicting needs of key stakeholders.
Proactively identify and resolve and/or escalate study-related issues.
Participate in process improvement initiatives or improving efficiency as needed.
Good understanding of clinical drug development process, GxP, and ICH.
Education:
Bachelor's in a scientific or technological field of study with five (5) years of relevant experience.
Master's or higher degree in a scientific or technological field of study with three (3) years of relevant experience.
Required Experience and Skills:
Project Management experience within the Science realm (or relative realm).
Preferred Experience and Skills:
Drug discovery experience, including familiarity with clinical trial execution in Oncology studies.
Biomarker assay experience including genomic/genetic, IHC, immunoassay, flow cytometry, mass spectrophotometry, and others.
Formal Project Management certification or training.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Hybrid
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
11/18/2024
Requisition ID:
R320256
#J-18808-Ljbffr
We are currently seeking a Senior Scientist within the Integrated Biomarker Operations organization to provide biomarker project management and operational expertise to support cross-functional clinical teams, ensuring the timely and efficient delivery of the biomarker operational aspects of each study.
This position will report into the Associate Principal Scientist of Project Management and be based either at Rahway, NJ, Upper Gwynedd, PA, San Francisco, CA, or Boston, MA site.
You will have experience in clinical biomarker assay execution and demonstrated success in project management. As a key contributor to the clinical biomarker strategy, you will be accountable for planning, implementation, and execution of clinical biomarker specimen collection, testing, and data delivery activities in clinical studies. The primary focus of this position is in oncology, although support of other disease areas may be required as therapeutic focus evolves.
The successful candidate will work closely with Biomarker leads, Assay scientists, Vendor Managers, and Clinical team to ensure that critical timelines are met by our vendors. You will also monitor Integrated Biomarker Operations processes, identify opportunities for improvement, and implement strategic solutions to ensure excellence in service delivery.
The selected candidate will have strong verbal and written communication skills and be expected to work independently in a highly collaborative and matrixed environment. You will excel under fast-paced and fluid conditions and be a strong advocate for operational excellence.
Primary responsibilities include, but are not limited to:
Collaborate closely with biomarker scientists and project teams to plan clinical trial biomarker set-up using logistical strategies to ensure efficient trial execution.
Be the operational partner to the Biomarker scientific leads to aid in implementing strategies that drive the biomarker program forward.
Participate as a co-author for drafting relevant biomarker sections of clinical study protocol.
Work closely with Translational Molecular Biomarker (TMB) Scientist to manage specimen collection, handling, shipping, and storage guidelines that align with the Biomarker plan and clinical study protocol.
Accountable for providing biomarker vendor assay statement of work and data transfer specifications to the clinical teams.
Work with data management to effectively transfer biomarker data to clinical data repository from external biomarker vendors.
Work with Clinical team and/or Central labs to design sample collection kits, laboratory manual, and specimen logistics for shipments to third party vendors.
Maintain and grow effective partnerships with external biomarker vendors and our Company's internal teams.
Coordinate sample and assay logistics and serve as a key point of contact with vendors/collaborators for timeline tracking, issue resolution, and risk mitigation.
Skills and Knowledge:
Well organized and methodical approach to problem solving.
Ability to understand and resolve conflicting needs of key stakeholders.
Proactively identify and resolve and/or escalate study-related issues.
Participate in process improvement initiatives or improving efficiency as needed.
Good understanding of clinical drug development process, GxP, and ICH.
Education:
Bachelor's in a scientific or technological field of study with five (5) years of relevant experience.
Master's or higher degree in a scientific or technological field of study with three (3) years of relevant experience.
Required Experience and Skills:
Project Management experience within the Science realm (or relative realm).
Preferred Experience and Skills:
Drug discovery experience, including familiarity with clinical trial execution in Oncology studies.
Biomarker assay experience including genomic/genetic, IHC, immunoassay, flow cytometry, mass spectrophotometry, and others.
Formal Project Management certification or training.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Hybrid
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
11/18/2024
Requisition ID:
R320256
#J-18808-Ljbffr