Nilay Shah

About Nilay Shah

Results-oriented Physician with a solid background and hands-on experience in global medical project and clinical operations management. • Over a decade experience in Phases I, II and interventional and non-interventional drug, device and biologic research studies worldwide including first in human trials. Successfully managed a pivotal phase trial of first in class novel biologic for a large Pharma Company.• Proven scientific and clinical trial expertise on cross functional teams with strong leadership and consensus building abilities focused on furthering organizational development and growth goals by managing new and existing pipeline opportunities and achieving value-creating inflection points through the disciplined practice of proven project management principles. • Knowledge of activities ranging from protocol development, through monitoring and data management to Clinical Study Report (CSR). • Successfully interacts and maintains relationships with Key Opinion Leaders (KOL), Scientific Advisory Committees (SAC) and Sponsors. • Proven leadership qualities with outstanding communication and planning skills and first-hand experience in public speaking and training. • Has the ability to make decisions quickly even with limited information. Committed to high quality, transparency and success. • Extensive experience in pharmacovigilance activities especially in safety reporting in clinical trials. • Continued success record of bringing in new business for the Organization. • Key role in setting-up overseas operations in India which involved knowledge of legal requirements, infrastructure setup, hiring the right people, developing relationships, making the organization fully operational and then taking it forward. • Well versed in several countries Regulatory requirements for conducting clinical trials.

Experience

1. SVP, Global Head of Ophthalmology

   Emmes

   Apr 2024 — Present · Rockville, MD, US

   As an entrepreneurial and forward-thinking leader within the CRO industry, I bring over 20 years of experience pioneering innovative strategies in clinical trials, majority of them being in the ophthalmology therapeutic area. Serving in a pivotal role at Emmes, I drive initiatives that challenge the status quo and foster out-of-the-box thinking to accelerate the development and commercialization of groundbreaking therapies on a global scale. Through building strong relationships with pharmaceutical and biotech sponsors and key stakeholders, I cultivate collaborations that propel novel ophthalmic treatments from concept to market reality. My role encompasses not only overseeing the entire therapeutic area but also devising creative approaches to streamline processes, optimize resource allocation, and mitigate risks. With a comprehensive understanding of industry best practices, my team and I collaborate closely with sponsors to design, implement, and manage clinical trial programs that adhere to the highest standards of quality and compliance. By embracing a dynamic and entrepreneurial mindset, I am dedicated to bringing new therapies to market that address unmet medical needs and transform patient care in the field of ophthalmology. Let\'s connect to explore how we can collaborate to shape the future of ophthalmic healthcare together.

Skills

• Lifesciences
• Clinical Development
• CRO
• Clinical Research
• Biotechnology
• Epidemiology
• Biostatistics
• Gcp
• Edc
• Clinical Trials
• Public Health
• Oncology
• Vaccines
• Cancer
• Drug Development
• Infectious Diseases
• Life Sciences