Our Team

Donya Bagheri, MA, DABT, is an accomplished Executive Director and Senior Director of Research & Development with over three decades of experience in clinical research, drug development, and regulatory science. She is a board-certified toxicologist (Diplomate of the American Board of Toxicology) specializing in management of complex U.S. and international clinical and preclinical research programs. Her expertise includes clinical trial oversight, data management, regulatory compliance (ICH, INDs, eCTD submissions), and development of electronic clinical trial systems (eTMF, EDC, CTMS, IRT, safety, dashboards). Under regulated environments, she has led as a Principal Investigator or Project Director, multimillion-dollar large-scale studies for NIH, NCI, FDA, industry sponsors, and public–private partnerships. Ms. Bagheri holds a MA in Toxicology with peer-reviewed publications

Michael Fehl, Chief Information Officer, is the architect and steward of CCSA’s entire technology enterprise, directing the secure computing environment that underpins the company’s work with federal health agencies and pharmaceutical and biotech clients. In a tenure spanning more than two decades, Mr. Fehl has shaped CCSA’s technology at every stage of its evolution — rising from hands-on engineer to executive leader and building an IT operation whose reliability, security, and continuity have earned the trust of the most demanding government and industry partners. He leads CCSA’s cybersecurity program, safeguarding the sensitive research, clinical, and regulatory data at the heart of the company’s mission and maintaining alignment with the stringent security and compliance standards expected of a partner to federal health agencies. Mr. Fehl also directs the company’s technology finances end-to-end, owning IT budgeting, capital planning, and vendor strategy — negotiating and managing the contracts, licensing, and supplier relationships that keep CCSA’s technology investments delivering maximum value. A relentless champion of innovation, he has driven CCSA’s modernization of its cloud and collaboration platforms and led the company’s early adoption of AI and emerging technologies, keeping CCSA at the leading edge of how scientific and regulatory services are delivered.

Ying Tang, PhD, RAC, Director, Clinical Research and Regulatory Affairs, has over 20 years of scientific and regulatory experience providing leadership in development and execution of regulatory strategies in the drug development life cycle, from first-in-human INDs to NDAs. She manages a broad product portfolio encompassing small molecules, biologics, and combination products in oncology, neurology, ophthalmology, and other indications. Dr. Tang critically evaluates study designs and data interpretation for both nonclinical and clinical studies for scientific rigor and regulatory compliance. She leads writing, reviewing, and finalizing regulatory dossiers for regulatory filing and manuscripts for peer-reviewed publication. She has extensive experience in direct engagement with FDA via email, phone, and formal meetings to achieve timely alignment on key regulatory matters. Dr. Tang is RAC-certified and holds a PhD in Pharmaceutical Sciences.

Meena Navidi, PhD, Senior Director, Preclinical Research and Development Projects, leads the teams providing scientific support for preclinical drug discovery and development programs. She has authored numerous worksheets, narrative summaries, Clinical Development Plans, Investigational New Drug applications (INDs), annual reports, and Clinical Trial Agreements. Dr. Navidi is an experienced research scientist with expertise in biochemistry, neurochemistry, animal physiology, nutrition, and in vitro receptor studies. She holds a PhD in nutritional sciences.

Megan Murphy King, PhD, MBA, is a senior scientific and regulatory affairs leader with more than 35 years of experience spanning drug discovery, preclinical and clinical development, regulatory strategy, and program management across oncology, neurology, and other therapeutic areas. Since the inception of the NCI Division of Cancer Prevention PREVENT Program, she has played a key leadership role in coordinating program activities, supporting agent evaluation and selection, and facilitating collaborations among federal staff, contractors, and external scientific review panels. Dr. King has extensive expertise in regulatory submissions and compliance, including INDs, NDAs, eCTD dossiers, clinical protocols, annual reports, and CMC documentation for drugs and vaccines, supporting major federal programs and industry sponsors. Prior to her regulatory leadership roles, she led research teams, advanced lead compounds into clinical development, and contributed to translational research across multiple therapeutic areas. Dr. King holds a PhD in Organic Chemistry and an MBA and is an inventor on more than 15 patents and patent applications and author of numerous scientific publications and presentations reflecting her contributions to medicinal chemistry, drug discovery, and pharmaceutical development.

Amy’s leadership is grounded in a deep understanding of the product lifecycle and shaped uniquely by leadership experience across manufacturing, quality, and global regulatory affairs. In her earlier role in quality control within the biopharmaceutical industry, she supported the successful startup of a greenfield biologics manufacturing facility, contributing to the establishment of a microbiology laboratory, implementation of quality systems, and operational readiness for GMP manufacturing. Today, she leverages that end-to-end product lifecycle experience to develop pragmatic CMC regulatory strategies and help clients successfully navigate global regulatory pathways. Amy has a Regulatory Affairs Certification (RAC) and holds an MS in pharmaceutical science and technology.

Sharanya Ramasubramanian, MS, is a Senior Manager of Clinical and Regulatory Operations at CCS Associates with over 15 years of experience supporting global clinical research programs. Her expertise includes clinical operations, regulatory submissions, site management, eTMF and essential records management, GCP compliance, vendor oversight, and project management. She has led and supported FDA and Health Canada submissions, including NDAs, INDs, and INADs, across oncology, neurology, cardiovascular, and digital health studies. Sharanya holds an MS in Bioscience Regulatory Affairs from Johns Hopkins University and has contributed to a RAPS publication on clinical protocol development.