Clora’s Top-tier Ophthalmology Experts

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

Clinical Development & Medical Affairs

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VP, Medical Affairs

  • Initials: W.G.
  • Location: New England
  • Therapeutic Areas: Neurology, Psychiatry, Ophthalmology 
  • Years of Experience: 25+ years experience in the Medical Affairs space, with involvement in more than 25 IND’s and NDA’s
  • Previous Companies: Previously held leadership positions at Celsion, Quintiles and various small/mid-size biopharma.
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VP, Clinical Development, Drug Safety and Medical Affairs

  • Initials: S.C.
  • Location: Florida
  • Therapeutic Areas:  Ophthalmology, Cardiovascular, Dermatology, Oncology
  • Years of Experience: 20+ years experience as Global Safety Physician, Medical Monitor and Clinical Development Consultant. Deep expertise in developing post-marketing strategies, clinical trial design, and global product launches.
  • Previous Companies: Previously held leadership positions at AstraZeneca, Genetech and various small/mid-sized biotechs

Regulatory Affairs

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Vice President, Regulatory Affairs

  • Initials: P.L.
  • Location: California
  • Therapeutic Areas: Ophthalmology, Psychiatry
  • Years of Experience: 20+ years experience in Regulatory Affairs for drug, diagnostics and device products. Led multiple regulatory teams towards successful NDA and 510k submissions. 
  • Previous Companies: Previously held positions at Amgen, Hospira and various small/mid-sized biotechs
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Director, Regulatory Affairs

  • Initials: T.C.
  • Location: California
  • Therapeutic Areas: Autoimmune/Inflammatory, Neurology, Oncology, Ophthalmology
  • Years of Experience: 20+ years experience in in Regulatory Affairs, with specific expertise in recombinant protein products (biotechnology) and CMC International regulatory FDA negotiations.
  • Previous Companies: Previously held positions at BioMarin, Amgen, Genentech and various small/mid-sized biotechs

CMC/Manufacturing

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VP, CMC

  • Initials: S.A.
  • Location: California
  • Therapeutic Areas: Ophthalmology, Cardiovascular
  • Years of Experience: 25+ years of broad experience in development and commercialization of new medical device and drug-device combination products. Highly experienced in process development, aseptic processing, terminal sterilization, troubleshooting, risk assessment, procurement, supply chain management, and in vivo polymerization. Products have included contact lenses, vascular closures, drug delivery, retinal closure devices, and ophthalmic implants.
  • Previous Companies: Previously held positions at Amgen and various small/mid-sized biotechs
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VP, Manufacturing and CMC

  • Initials: I.S.
  • Location: West Coast
  • Therapeutic Areas: Autoimmune/Inflammatory, Oncology, Ophthalmology
  • Years of Experience: CMC leader with 25+ years experience driving all non-clinical R&D- medicinal chemistry, process chemistry, biology, ADME-PK, intellectual property and toxicology. Author of CMC regulatory documents: IND, CTA, ANDA, sNDA and NDA filings and CMC Development team leader on >30 clinical candidates
  • Previous Companies: Allergan, Astex, and Pfizer

Clinical Operations

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Senior Clinical Project Manager

  • Initials: D.S.
  • Location: New England Area
  • Therapeutic Areas: Ophthalmology, Neurology, Infectious Disease, Cardiovascular, Immunology
  • Years of Experience: 25+ years experience in Clinical Operations, including 10 years managing global phase I-IV ophthalmology clinical trials
  • Previous Companies: Previously held positions at Vertex, AstraZeneca, and Boston Scientific
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VP, Clinical Operations and Clinical Strategy

  • Initials: J.P.
  • Location: New England Area
  • Therapeutic Areas: Ophthalmology, Infectious Disease, Pediatrics
  • Years of Experience: 20+ years experience in Clinical Operations, successfully building clinical operations departments and deep expertise in vendor oversight, US and EU regulatory submissions, and asset due diligence.
  • Previous Companies: Previously held positions at Pfizer and various small/mid-stage biotechs.

DM/ Stats

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Associate Director, Data Management

  • Initials: K.T.
  • Location: Florida
  • Therapeutic Areas: Ophthalmology
  • Years of Experience: 20+ years experience in Data Management, contributing SAS and data management support to over 40 phase I-III ophthalmology studies.
  • Previous Companies: Previously held positions at Novartis, CIBA Vision and various small/mid-sized biotechs
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Head of Clinical Data Sciences

  • Initials: A.S.
  • Location: PA
  • Therapeutic Areas: Ophthalmology, Infectious Disease, Neurology, Oncology
  • Years of Experience: 25+ years experience in Clinical Data Management, responsible for data management and data analysis activities for multiple regulatory submissions in several therapeutic areas, including Oncology, Vaccines and Ophthalmology.
  • Previous Companies: Previously held positions at Astellas Pharma, Pfizer and various small/mid-sized biotech