We are seeking to hire a Precision Medicine Scientific Lead to oversee the development and execution of biomarker strategies for novel cell therapies, cell transfer conditioning agents and combinations with bispecific antibodies across multiple disease areas (Oncology and Immunology). In this highly matrixed role, they will design, develop, communicate across levels and operationally implement clinical biomarker strategies to support selecet programs in early and late stage drug development. Clinical biomarker assays include pharmacokinetic assays, mechanism of action, patient stratification assays and pharmacodynamic assays. The candidate will collaborate with teams internal to RCM and more broadly Regeneron or with contract research organizations to develop and implement clinical biomarker assays.
As a Director, a typical day may include the following:
1. Program-level Precision Medicine lead that develops and implements the strategic vision for pharmacokinetic, pharmacodynamic, and exploratory biomarkers for clinical studies enabling indication and/or patient selection, early indication of biological activity, and to identify potential novel combinations.
2. String collaboration with Biomarker and clinical operation teams to implement specific biomarker and exploratory sample collection and analyses in all relevant clinical studies in selected programs
3. Key individual contributor and precision medicine representative to development and Cell therapy characterization teams with a remit to integrate, influence and deliver biomarker strategies from initial concept to execution, data delivery and results interpretation.
4. Collaborate with internal Regeneron laboratories and groups (e.g. BioAnalytical, Clinical Pharmacology, Molecular Profiling, CDX, Discovery Research, Analytical Innovations, DMSQ etc.) to develop plan for validation and application of assays in the clinic.
5. Accountability for ensuring complex clinical assays used in programs are fit-for-purpose (whether developed and validated internally or externally)
6. Collaborate with Discovery Research and product development teams to facilitate appropriate incorporation of Precision Medicine biomarker strategies for molecules in discovery phases (leading to candidate molecule selection) through to the clinic.
7. Represent Regeneron externally thorough collaborations and/or presentations.
8. Contribute to Clinical Protocol, schedule of Assessments, clinical study reports, technical reports, data agreements, scientific publications and make recommendations to development teams and management
This role may be for you if:
9. The ability to drive, manage, complete and deliver results for complex multi-functional projects
10. Excellent communication and presentation skills and high emotional intelligence, organizational skills and effective team skills
To be considered for this role, you must have a PhD and 10+ years of experience participating effectively on cross-disciplinary teams in pharmaceutical or biotech industry. Experience in clinical assay development, validation and implementation with strong experience in Immunology is preferred.