Title: Associate Director, Clinical Biomarker Lead
Reports to: Head of Clinical Pharmacology and Pharmacometrics
Overview
Clinical biomarkers play an essential role in advancing our mission of developing small molecule mutation-specific p53 reactivators for the treatment of cancer. Clinical biomarker evaluations are integral to the success of our precision medicine, tumor agnostic approach. Clinical biomarker evaluations will help us gain insight into which patients are likely to benefit from our drug candidates and will advance our understanding of the biological consequences of p53 reactivation and its association with tumor response.
Responsibilities

• Design and execute clinical biomarker strategy for programs in clinical development with cross-functional collaboration.
• 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 provides 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.

Qualifications

• BS or advanced degree (PhD preferred), in a scientific discipline, with a solid understanding of tumor biology
• 8 years of experience working in R&D at a biotech/pharma company with at least 3 years' experience in clinical biomarker strategy, data analysis and interpretation
• Experience with next generation sequencing assays and results interpretation required
• Oncology experience required
• Experience with managing multiple vendors
• Proficient with Microsoft Office applications (Word, Excel, PowerPoint, etc.)
• Working knowledge of ICH GCP regulations

Attributes

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