Scott Oshana is the President and Founder of New England Clinical Consulting (NECC), a highly reputable clinical operations consulting firm providing expert services to biotechnology and pharmaceutical companies. With over 41 years of experience in the clinical research and drug development sector, Scott has cultivated a distinguished career characterized by his proven track record of successfully delivering clinical trials across multiple therapeutic areas, phases, and geographies.

Scott’s expertise spans a wide range of specialties, including oncology, infectious diseases, immunology, pain management, diabetes, gastrointestinal (GI) conditions, central nervous system (CNS) disorders, and more. His comprehensive understanding of these therapeutic areas has enabled him to offer invaluable insights into the complexities of drug development, clinical operations, regulatory affairs, data management, and clinical research.

As the driving force behind NECC, Scott has led the company since its founding in 2018, delivering clinical operations solutions to companies of all sizes and stages. His core competencies include selecting and overseeing contract research organizations (CROs), designing and implementing clinical protocols, site relationship management, managing clinical site monitoring, data management, oversight of Data Safety Monitoring Boards (DSMBs), regulatory submissions, and developing clinical operations strategies. He is particularly adept at building and leading high-performance clinical operations teams, ensuring that projects are executed efficiently and in compliance with Good Clinical Practice (GCP) standards and International Council for Harmonisation (ICH) guidelines.

Before founding NECC, Scott held leadership roles in several prominent pharmaceutical and biotechnology companies. As Vice President of Clinical Operations at Asahi Kasei Pharma America, he was responsible for overseeing clinical operations, data management, regulatory submissions, and global drug development initiatives. His earlier roles include Senior Director of Clinical Operations at Millennium Pharmaceuticals, where he managed small molecule and antibody clinical trials, focusing on oncology and inflammatory diseases. Scott’s experience also extends to startup environments, as evidenced by his work at Achillion Pharmaceuticals and Predix Pharmaceuticals, where he contributed to clinical operations, toxicology, CMC, and regulatory affairs for infectious disease therapeutics.

Throughout his career, Scott has demonstrated his ability to navigate the complex landscape of clinical trials, from early-phase development through global Phase 4 studies. His leadership in operational planning, project management, data management, and CRO selection and oversight has been instrumental in delivering successful outcomes for a range of clinical programs.

Scott is highly regarded for his ability to foster teamwork, build strong relationships, and lead cross-functional teams to success. His leadership style is characterized by a commitment to operational excellence, regulatory compliance, and a deep passion for advancing clinical research and innovation.

In addition to his professional accomplishments, Scott has been a sought-after speaker at industry conferences, particularly in roundtable discussions on clinical studies. He has shared his expertise in clinical trial design, regulatory interactions, and global drug development with peers and industry leaders.

Scott holds a Bachelor of Science (BS) in Biology from Purdue University. His technical skills and expertise in areas such as clinical study design, clinical data management, vendor selection and oversight, SOP writing, CRF design, and electronic trial master files (eTMF) development  have earned him widespread recognition in the field. His passion for the industry, coupled with his ability to get the job done, makes him a valuable asset to any organization looking to excel in clinical research and drug development.

Outside of his professional work, Scott enjoys travel, weightlifting, spending time with his family and reading. He remains open to new challenges and opportunities, both domestically and internationally, as he continues to make significant contributions to the biotechnology and pharmaceutical industries.

Character:

Scott Oshana embodies a results-driven mindset, consistently demonstrating a strong work ethic and commitment to excellence. His leadership style is rooted in integrity, accountability, and a relentless drive to achieve success in every project.

Knowledge:

With over 41 years of experience in clinical research and drug development, Scott has a deep understanding of operational management , regulatory requirements. His expertise spans a broad range of medical fields, from oncology to infectious diseases, making him a versatile leader in the biotech and pharma industries.

Strategic:

Scott’s strategic approach is evident in his ability to lead complex clinical trials and navigate regulatory landscapes. He excels in creating and executing clinical operations strategies, ensuring that projects meet both short-term objectives and long-term goals in a competitive industry.

Communication:

Known for his clear and effective communication, Scott fosters collaboration across teams and stakeholders. His ability to convey complex clinical and operational information in a way that drives understanding and action has been key to his success in developing and leading high-performance teams.