Associate Director, Clinical Scientist, Cardiovascular/Metabolic disease
- Full-time
Build our future together:
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Associate Director, Clinical Sciences (Internal Medicine) to join our Clinical Sciences team, supporting our global clinical development programs in cardiovascular, renal, and metabolic disease. In this role, you will lead the design, execution, and scientific interpretation of clinical studies, ensuring data integrity and patient safety while partnering closely with Medical Directors and cross-functional teams. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
When & where:
- Location: Tarrytown, NY, Warren, NJ, Cambridge, MA
- Work model/flexibility: Primarily on-site with hybrid flexibility
Discover your role:
- Lead clinical studies and programs in a matrix environment, serving as lead Clinical Scientist or delegate for the therapeutic area
- Partner with Medical Directors to deliver the scientific expertise needed to design and complete early and/or late-phase studies
- Develop expanded synopses and author or review protocols, amendments, medical monitoring plans, SAPs, informed consents, and clinical study report sections
- Propose and communicate study strategies grounded in the supporting literature and a deep understanding of the disease area, mechanism of action, and drug landscape
- Present data and plans to investigators, governance bodies, DMCs, and regulatory authorities, and contribute to advisory boards and steering committees
- Perform clinical and medical data review, including safety monitoring, to protect patient safety while upholding FDA, EMA, ICH, and GCP standards
- Identify risks, design mitigation strategies, and promote consistent data review practices across studies and programs
- Mentor and coach junior team members and cross-functional colleagues
This role requires:
- MS/PhD/PharmD in a related field with 10+ years of pharmaceutical clinical drug development experience (other levels considered depending on experience)
- Experience managing clinical trials in one or more of the following therapeutic areas: cardiovascular, renal, or metabolic disease
- Proficient knowledge of the drug development process, GCP, ICH guidelines, study design, and clinical research methodology
- Solid medical writing skills, with the ability to communicate clear, concise messages and present with confidence
- Demonstrated leadership in conducting global clinical trials and executing clinical programs
- Proven ability to influence cross-functionally, resolve novel problems creatively, and drive clinical trial process improvements