Clora’s Top-tier GI Experts

Access Clora’s expertise to develop an all-star GI team for your pipeline

Preclinical Development 

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Manager, Pharmacology and Toxicology

  • Initials: R.T.
  • Location: New York
  • Therapeutic Areas: Endocrine, Gastrointestinal, Hematological, Infectious Disease, Metabolism / Nutrition, Nephrology, Neurology, Pulmonary
  • Years of Experience: 10+ years in the biopharma industry with specific expertise utilitizing pharmacokinetic/pharmacodynamic principles to facilitate drug development across nonclinical and clinical development stages (mostly for small molecule and biologic candidates).
  • Previous Companies: Proctor & Gamble and ICON
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Director, Pharmacology and Preclinical Devlopment

  • Initials: K.D.
  • Location: Southwest
  • Therapeutic Areas: Allergy/ Immunology, Autoimmune/Inflammatory, Infectious Disease, Metabolism/Nutrition, Neurology, Oncology
  • Years of Experience: Pharmacologist with over 30 years in the biopharma industry. Experience with FDA across IND, BLA, and INTERACT meetings and specialties in gene therapy and DNA & RNA therapeutics with a preference to work on early-stage development.
  • Previous Companies: Charles River Laboratories and various small biotech

Clinical Development and Medical Affairs

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Medical Director

  • Initials: K.C.
  • Location: Research Triangle Park
  • Therapeutic Areas: Cardiovascular, Neurology, Oncology, Psychiatry, Gastrointestinal
  • Years of Experience: Physician with 25+ years of extensive experience in medical monitoring, drug safety and pharmacovigilance. Experience in all phases of drug development including phase I first in man though pivotal phase III and ongoing safety phase IV studies.
  • Previous Companies: Previously held leadership positions INC Reserach and various biotech companies (small to mid-stage)
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VP, Clinical Research, Medical Director

  • Initials: W.H.
  • Location: West Coast
  • Therapeutic Areas: Gastrointestinal, Hematological, Neurology, Oncology
  • Years of Experience: 30+ year career as an innovative and collaborative experienced Clinical and Medical Research Professional who consistently delivers on the critical responsibility of understanding pharmacological actions of targets and drugs, and has advanced and approved them.
  • Previous Companies: Celgene, Medimmune, Eisai, Various biotech
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Manager, Medical Affairs

  • Initials: R.X.
  • Location: West Coast
  • Therapeutic Areas: Cardiovascular, Endocrine, Gastrointestinal, Nephrology, Oncology, Pain
  • Years of Experience: 10+ years of experience in med device and biopharma, across the marketing and medical affairs space. Experience includes leading the response to medical information requests from HCPs, regulatory agencies, field sales force and internal team, driving the development of scientific communication content in collaboration with KOLs, study investigators and medical writers (conference abstracts, podium presentations, case studies, consensus papers and manuscripts).
  • Previous Companies: Previous roles at Eli Lilly and Boston Scientific.

Regulatory Affairs

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Regulatory Affairs Manager

  • Initials: A.T.
  • Location: Midwest
  • Therapeutic Areas: Gastrointestinal, Oncology, Vaccines
  • Years of Experience: Compliance and Regulatory professional with 27+ years of experience in biotechnology CMC and GxP compliance. Experienced in regulatory submissions and meetings, from IND to BLA.
  • Previous Companies: Small, early-stage biotech companies

VP, Regulatory Affairs

  • Initials: A.Y.
  • Location: New York
  • Therapeutic Areas: Gastrointestinal, Endocrine, Metabolism / Nutrition, Neurology, Pain, Rare Disease
  • Years of Experience: 3+ decades of predominantly IND and NDA experience. Spearheaded several pre-IND and IND-related activities and has led the interactions with several regulatory bodies., as well as a lead RA expert for three orphan designated drugs.
  • Previous Companies: Sanofi, Schering Plough, and several small biotech companies.

Clinical Operations

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Senior Clinical Project Manager

  • Initials: D.S.
  • Location: New England Area
  • Therapeutic Areas: Cardiovascular, Gastrointestinal, Hematological, Infectious Disease, Neurology, Oncology
  • Years of Experience: 20+ years of experience as a Global Clinical Manager with a strong background in Project Management and GCP Quality Assurance. Extremely effective at developing and empowering cross-functional and culturally diverse team members. Director of consulting group, leading all clinical operations and managing a large number of projects in multiple countries/phases of development.
  • Previous Companies: Previously held positions at Pfizer, Novartis and several small biotech companies.
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Sr. Director, Clinical Operations

  • Initials: M.K.
  • Location: Pacific NW
  • Therapeutic Areas: Cardiovascular, Gastrointestinal, Metabolism / Nutrition, Neurology, Oncology, Ophthalmology, Urology
  • Years of Experience: Seasoned professional with documented success in attaining corporate goals over a 19+ year career. Solid leadership credentials with a strong focus on building and managing successful teams. Adept at executing global early phase as well as late-phase clinical trials, leading study operational plan, and overseeing selection and management of CRO activities.
  • Previous Companies: Takeda and Various Small Biotech

CMC/Manufacturing

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Product Development Manager

  • Initials: J.V.
  • Location: Research Triangle
  • Therapeutic Areas: Cardiovascular, Gastrointestinal, Infectious Disease, Oncology, Urology, Virology
  • Years of Experience: Over 16 years of experience in the manufacturing industry, across pharmaceuticals, medical devices, and biotechs. Managed the whole New Product Development Process, Risk Management and Design Control stages for the domestic and international launch of new family of products. Led the execution of product/process changes, Feasibility Studies, Packaging Design, Label Approval process, keeping Projects within scope, budget and schedule.
  • Previous Companies: VistaPharm, Bristol Meyers Squibb, Integra, Various biotechs
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Director, CMC and Analytical Development

  • Initials: J.S.
  • Location: New England Area
  • Therapeutic Areas: Gastrointestinal, Oncology
  • Years of Experience:An accomplished leader in the biopharmaceutical industry with more than 20 years experience in providing technical and strategic leadership for Analytical Development, Quaity Control, CMC. and technical operations. Experience in preparing CMC packages for global regulatory submissions.
  • Previous Companies: Worked across large and small biopharma (biologics and small molecules)

Biostatistics, Data Management & Medical Writing

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Data Management Consultant

  • Initials: K.M.
  • Location: Research Triangle
  • Therapeutic Areas: Infectious Disease, Oncology, Vaccines, Cardiovascular, Gastrointestinal, Neurology
  • Years of Experience: Research Study (Pharmaceutical/Device/CPG) Leader and Individual Contributor with more than 4 decades of global experience managing projects across multiple therapeutic areas. Experience in phase I-IV clinical, device, and consumer goods research studies.
  • Previous Companies: Moderna, ImmunoGen, ICON, Various Biotechs
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VP, Biostatistics

  • Initials: J.D.
  • Location: Mid-Atlantic
  • Therapeutic Areas: Gastrointestinal, Oncology, Pain
  • Years of Experience: 30+ years seasoned statistician experienced in bringing numerous products to market. Areas of expertise include Clinical Plan Development, Data Monitoring Committees, Ad Comms, FDA interaction, SOP development. Specialties: statistical design and analysis consultation; DMC expertise; NDA experience (10 product approvals recently); regulatory interactions representing biostatistics; FDA advisory meeting representation.
  • Previous Companies: Wyeth and Hoffman-La Roche
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Manager, Medical Writing

  • Initials: J.W.
  • Location: New York
  • Therapeutic Areas: Cardiovascular, Endocrine, Gastrointestinal, Metabolism / Nutrition
  • Years of Experience: 10 years of medical writing/project/trial management experience and 8 years of regulatory expertise. Designed, developed and managed multiple large research programs (phase I-IV), and provided scientific leadership in IND/NDA/BLA submissions.
  • Previous Companies: Astrazeneca and several small biotech companies.