Associate Director/Director, Translational Biomarkers

POSITION SUMMARY

Amunix, a Sanofi Company, is expanding its pipeline and capabilities and is seeking outstanding Associate Director/Director, Translational Biomarker lead with experience in immuno-oncology and cancer biology to help further develop safe and effective medicines for cancer patients. The ideal candidate is a highly motivated and team-oriented individual that possesses the ability to work across a highly matrixed environment to provide technical and scientific expertise for advancing drug discovery programs from preclinical studies through IND filing and clinical development. The candidate will be based in South San Francisco and work in a multicultural environment with colleagues at different geographic locations (US and EU).

ESSENTIAL FUNCTIONS

• Working with early clinical development teams, the candidate will have the opportunity to develop clinical biomarker plans for immuno-oncology programs from the pre-candidate selection up to submission stage
• Responsible for delivering high quality biomarker strategies for patient selection, target engagement and pharmacodynamics endpoints
• Manages CROs and activities related to clinical biomarker assays (from assay development to sample analysis) in collaboration with bio sample operations
• Analyzes, interpret, and communicate biomarker data to support clinical trials and clinical development decision-making
• To achieve these goals, the candidate will partner with internal functions such as biomarker operations, assay development labs, biostatistics, bio-informatics experts, PK and clinical team
• Lead the translational medicine sub team with representatives from these functions, coordinating efforts for data generation, interpretation and manage communication flow related to key biomarker program information, risks and milestones across key stakeholders including therapeutic area leadership, functional leads and team members
• Provide input to clinical teams on biomarker-related elements of clinical protocols, lab manuals and consent forms
• Provide scientific expertise and technical guidance to enable timely biomarker sample collection
• Point contact for resolving study biomarker issues
• Interface with discovery laboratories to drive implementation of preclinical/translational projects based on emerging clinical/translational datasets

QUALIFICATIONS

• PhD or MD required
• Fluent English mandatory
• 5+ years of relevant experience in pharmaceutical industry setting in the application of biomarkers in Immuno-Oncology clinical trials
• Deep knowledge of cancer biology, biomarker strategies and application to clinical trials
• Experience in high-impact contributions to biomarker discovery and/or assay development
• Experience in conducting biomarker analyses on various clinical sample types and working as part of a clinical study team
• Experience in managing research collaborations, contract laboratories and budgets
• Demonstrated scientific capability as evidenced by publications, research reports, and external presentations
• Effective verbal and written communication skills
• Flexibility to work on multiple projects as the portfolio evolves over time
• Up to date knowledge and deep understanding of major molecular and genomic assay technologies and platforms
• Having a strong sense of urgency and excellent skills in prioritization, planning as well as timely execution in a very fast-paced environment
• Strong interpersonal skills and ability to thrive in a matrix environment

ABOUT AMUNIX

Amunix is a Sanofi Center of Excellence that is leveraging our expertise in precision protein engineering to enable the promise of T cell engagers in solid tumors. Our goal is to improve the lives of people with cancer in pursuit of cures through the development and commercialization of breakthrough therapies that harness the immune system. We have designed XTEN, a validated therapeutic half-life extension technology. Our current focus is Pro-XTEN, a next-generation protease activated pro-drug platform, which enables selective activation of potent cancer therapies in the tumor microenvironment. This overcomes a common challenge facing potent immune system activators: on-target, off-tumor toxicity. Amunix’s lead programs employ the Pro-XTEN technology to enhance the safety profile of T cell engagers. XPATs (XTENylated Protease-Activated T Cell Engagers) have the potential to make off-the-shelf therapies redirecting T cells to solid tumors a reality.

Amunix provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics. In addition to federal law requirements, Amunix complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfers, leaves of absence, compensation, and training.

Please be advised that Amunix requires that all employees have the COVID-19 vaccination to work onsite, unless the employee has an approved medical or religious exemption.