• Design and execute clinical biomarker strategy for programs in clinical development in collaboration with Translational Medicine.
• Ensures feasibility of biomarker strategies and plans within the overall scope and objectives of a planned clinical study.

• Authors and reviews biomarker sections of clinical documents (e.g. protocols, lab manuals, and study reports) to ensure biomarker assessments are accurately described.

• Provides technical guidance for biomarker sample collection and handling and provide clinical site staff training related to biomarker collections.
• Sets the technical specifications of the biomarker assays proposed for use in clinical studies.
• Leads biomarker specialty lab vendor selection process for clinical studies, in collaboration with other functional area leads as needed.
• Manage biomarker vendors from contract negotiations through to data deliverables to ensure high quality, on-time results within the scope of the study budget.
• Collaborates with Operations to ensure samples are collected and handled according to established procedures.
• In collaboration with Clinical Development, Biostatistics, Clinical Pharmacology, and Translational Medicine, develops a biomarker analysis plan to support clinical studies, as appropriate.
• Works with Clinical Data Management to establish appropriate processes for the transfer and storage of clinical biomarker data.
• Synthesizes biomarker results in a timely manner to support clinical team decision making (working with bioinformatics as needed)
• Meets regularly with cross-functional team (representation from Project Management, Regulatory, Clinical Development, Clinical Operations, and Clinical Pharmacology) to share biomarker results
• Participates in companion diagnostic strategy and plans, in collaboration with the Regulatory and Clinical Development teams.
• Remains up to date on new and emerging technologies related to tumor molecular markers.

• Highly motivated with a strong desire to make a difference to human health
• High level of accountability
• Excellent oral and written communication skills
• Thinks strategically with a view to overall scope of the program
• Works effectively in teams
• Willingness to learn new skills

• BS degree in scientific discipline, with a solid understanding of tumor biology; postgraduate science degree a plus
• ≥8 years of experience working in R&D at a biotech/pharma company with experience in clinical biomarker strategy, data analysis and interpretation
• Proficient with Microsoft Office applications (Word, Excel, Powerpoint etc)
• Experience with managing multiple vendors
• Experience with next generation sequencing assays and results required
• Oncology experience required
• Working knowledge of ICH GCP regulations

• PMV provides a competitive medical benefits package, a generous PTO policy, competitive salaries, Employee Stock Purchase Plan, Employee Referral Program, and much more.

PLEASE, NO PHONE CALLS or AGENCIES