Senior Scientist, Biomarker Operations, Project Management

$111,400 - $175,300/Yr

Merck KGaA Darmstadt Germany

Full-time - Senior

Onsite

Chemical Manufacturing

About the position

The Senior Scientist position within the Integrated Biomarker Operations organization focuses on providing project management and operational expertise for clinical biomarker studies, primarily in oncology. The role involves collaborating with cross-functional teams to ensure timely delivery of biomarker operational aspects, including specimen collection, testing, and data delivery. The successful candidate will be responsible for planning, implementation, and execution of biomarker strategies, while also identifying opportunities for process improvement and ensuring operational excellence.

Responsibilities

• Collaborate closely with biomarker scientists and project teams to plan clinical trial biomarker set-up using logistical strategies to ensure efficient trial execution.
• Act as 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.
• Collaborate 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 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.

Requirements

• 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.
• Project Management experience within the Science realm (or relative realm).

Nice-to-haves

• 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.

Benefits

• Bonus eligibility
• Long term incentive if applicable
• Health care and other insurance benefits (for employee and family)
• Retirement benefits
• Paid holidays
• Vacation
• Sick days