Kinase ClinDev
Catalyzing Clinical Development Success
Catalyzing Clinical Development Success
Expert consulting services for pharmaceutical, biotech, and startup companies
Get StartedTransform your clinical program with expert-crafted development strategies that optimize timelines and resources.
Convert scientific objectives into executable protocols that satisfy regulatory requirements while minimizing operational hurdles.
Navigate complex regulatory landscapes with strategies that anticipate agency expectations and minimize approval timelines.
End-to-end management of clinical trials with expertise in CRO selection, site management, and operational excellence for early phase studies.
I offer these flexible engagement options, customizable to your specific requirements. Contact me to discuss which approach best suits your needs.
Strategic guidance and expert advice to complement your existing team's capabilities
Defined deliverables with clear scope, timelines, and fixed pricing
Regular support with guaranteed availability and response times
Temporary team augmentation during critical development phases
Full ownership of clinical initiatives, including trial management, site coordination, and CRO oversight
Temporary leadership in Director/VP roles during transitions or while building your team
Work directly with a senior-level consultant without layers of management
Access specialized expertise without the overhead of large organizations
Receive timely support from someone fully dedicated to your success
Adapt engagement scope as your needs evolve
Work across multiple therapeutic areas, without single-specialty constraints
Proactive problem-solving approach with proven ability to navigate complex trial logistics and deliver results on time and within budget
I'm a physician-scientist with expertise spanning protocol design, pharmacovigilance, and regulatory compliance across biotech startups and academic institutions.
My background includes leading clinical development for novel COVID-19 vaccine projects in South Africa and Australia, designing comprehensive trial protocols for medical devices, and authoring contract proposals for the CDC. I've successfully led pharmacovigilance departments, managed global vendors, and authored statistical plans that balance scientific rigor with operational feasibility.
Prior to consulting, I held positions at Alvea Holdings, Icahn School of Medicine at Mount Sinai, and various medical institutions, gaining experience in both clinical practice and research environments. I hold an MBBS (US-MD equivalent) and training in Clinical Research from Mount Sinai.
My experience includes managing cross-functional teams and CROs for early phase clinical trials across international sites. I've successfully led site selection, monitored study performance, and ensured regulatory compliance while maintaining data integrity and quality throughout the trial lifecycle.
My approach combines scientific expertise with practical implementation, identifying strategic efficiencies while maintaining quality. I work effectively across multiple therapeutic areas, engaging subject matter experts when needed to provide both breadth and depth of expertise.
Contact: mitisaksena@gmail.com
LinkedIn: LinkedIn Profile
Ready to accelerate your clinical development? Get in touch with our team of experts.
Email: info@kinaseclindev.com
LinkedIn: KinaseClinDev