As part of the Precision Medicine team, this Associate Director will independently lead implementation of a biomarker strategic vision for development programs across one or more therapeutic focus areas (TFAs). In this role, they will design, develop, communicate at senior levels and operationally implement Precision Medicine strategies to support all relevant programs in early and late stage drug development for Cardiovascular and Metabolism related programs. Clinical technologies applied include biomarker assays, pharmacogenetic assessments, as well as other clinical and physiological testing devices. Such technologies will be applied towards the goals of: 1) enhancing our understanding of indications at a cellular and molecular level, 2) conducting novel biomarker discovery, 3) qualifying new biomarkers/approaches to expedite proof-of-concept for new drug candidates, 4) optimizing label claims for later stage candidates, and 5) enabling personalized medicine principles to be applied, as appropriate, in full development. The role requires in-depth knowledge of implementing precision medicine in clinical development, broad understanding of disparate biomarker technologies, and deep experience in biomarker assay development and validation in clinical drug development. The Associate Director will be responsible for conducting in-depth literature and technology reviews pertinent to all clinical development programs within the TFA, identifying and pulling in experts in multiple disease areas, navigating and supporting the logistical and regulatory factors pertaining to clinical technologies. The Associate Director will closely collaborate with various research colleagues, (e.g. Discovery Research, Molecular Profiling, DNA Core, Regeneron Genetics Center), colleagues within various departments in early and late development, clinical operations and colleagues from allied companies for collaborations. The Associate Director will participate on strategic project teams, clinical sub teams, and joint project teams as needed, and will prepare and make regular high-level presentations to development team leadership and senior management both to propose PM strategies and summarize outcomes of PM-driven research.
A day in the life of an Associate Director, Precision Medicine may include the following:
- Program-level PM lead for implementation of program-level strategic vision that will broadly enable advances in target identification, indication selection, early indication of biological activity and patient stratification/selection within the assigned TFA(s)
- Provide strategic leadership and influence cross-functional teams to prioritize and execute a compelling Precision Medicine vision within the TFA(s) that will broadly enable advances in target identification, indication selection, early indication of biological activity and patient stratification/selection
- Collaborate with Discovery Research and product development teams within the TFA to facilitate appropriate incorporation of Precision Medicine strategies for molecules in discovery phases (leading to candidate molecule selection) or development
- Represent Regeneron and work with colleagues from allied companies for all of the assigned TFA's programs covered within the alliance, to develop and implement Precision Medicine strategies for partnered alliances
- Collaborate with clinical operations teams to implement exploratory sample collection and analyses in all clinical studies within the TFA
- Design, oversee and manage internal and external research collaborations in areas of clinical technologies and translational research.
- Accountability for ensuring complex clinical assays used in all programs throughout the TFA portfolio of clinical development are fit-for-purpose (whether developed and validated internally or externally)
- Collaborate with internal Regeneron laboratories (e.g. Discovery Research, Molecular Profiling, Regeneron Genetics Center, DNA core, BioAnalysis, etc.) to develop plan for validation and application of research assays.
- Ensure timely delivery of results across all programs within the TFA, consistent with program team and senior management expectations in a way that maximizes the potential impact of Precision Medicine deliverables on Global Development programs.
- Contribute to and ensure the quality of Precision Medicine technical reports, study memos and clinical study reports, data reviews and interpretations, scientific publications and recommendations to development teams and management.
- Contribute to and review documents pertaining to regulatory interactions and filings related to Precision Medicine, including product labeling and participates as appropriate in internal and external meetings.
This job may be for you if you have the following:
- Ph.D. and/or M.D.
- 10+ years' experience participating effectively on cross-disciplinary teams in pharmaceutical or biotech industry, including at least 2-5 years in clinical development, with a track record of high impact in drug development.
- Experience in cardiovascular/fibrosis and/or metabolism drug development.
- Extensive insight and experience in basic, translational or clinical research related to biomarkers, pharmacogenetics, imaging, and/or other clinical technologies. Strong understanding of technical, regulatory, clinical, and strategic aspects of these areas required.
- Ability to drive, manage, execute and deliver results for complex multi-functional projects required
- High emotional intelligence, organizational skills and effective team skills required
- Excellent communication and presentation skills required.
- Excellent track record in mentorship and development of direct reports strongly preferred
- Evidence of positive influence of senior leaders and effective team skills required
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need. #LI-SKC