Clora’s Top-tier Rare Disease Experts

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

Preclinical Development


Director, Scientific Affairs

  • Initials: A.C.
  • Location: Research Triangle Park
  • Therapeutic Areas: Autoimmune/Inflammatory, Rare Disease, Hematology, Cardiovascular, Infectious Disease, Neurology, Oncology, Ophthalmology, Pulmonary/Respiratory
  • Years of Experience: 20+ years of experience assisting companies with PK/PD related matters. Worked on INDs and BLAs involving small molecules and protein therapeutics.
  • Previous Companies: GSK, Otsuka

Senior Director, Toxicology

  • Initials: R.E.
  • Location: West Coast
  • Therapeutic Areas: Cardiovascular, Gastrointestinal, Hematological, Metabolism, Pain, Vaccines, Rare Disease
  • Years of Experience: Seasoned toxicology, pharmacology, and nonclinical consultant with 30+ years experience with a record of successful global regulatory submissions. Well-versed in the GLP/non-GLP spaces and has primarily worked with small and large molecules.
  • Previous Companies: Charles River Laboratories, WuXi AppTec

Clinical Development & Medical Affairs


SVP, Head of Clinical Development

  • Initials: R.W.
  • Location: Greater NY/NJ Area
  • Therapeutic Areas: Oncology, Rare Disease
  • Years of Experience: Senior Clinical Development expert with 20+ years experience in developing protocols and determining regulatory strategy for both early and late stage programs.
  • Previous Companies: Schering-Plough, Novartis

Director, Clinical & Preclinical Development

  • Initials: S.S.
  • Location: West Coast
  • Therapeutic Areas: Hematological, Oncology, Rare Disease
  • Years of Experience: 20+ years of experience working on the preclinical and clinical development of cell and gene therapies and cord blood expansion programs. BMT expert with significant experience in both translational and clinical research. Well-versed in the IND process and submission as well as the regulatory requirements for cell and gene therapies.
  • Previous Companies: Bluebird Bio, Various Small Biotechs

VP, R&D Program Leadership

  • Initials: J.G.
  • Location: Southeast Area
  • Therapeutic Areas: Endocrine, Oncology, Hematology, Rare Disease, Dermatology
  • Years of Experience: 25 years global drug development and medical affairs experience in biotech, pharmaceutical, and CRO settings; broad industry expertise with emphasis on specialty medicines including immunology, rare diseases and biologics.
  • Previous Companies: Shire, Bristol-Myers Squibb

Regulatory Affairs & QA


VP, Regulatory Affairs

  • Initials: A.Y.
  • Location: Greater NY/NJ Area
  • Therapeutic Areas: Gastrointestinal, Endocrine, Metabolism / Nutrition, Neurology, Pain, Rare Disease
  • Years of Experience: 30+ years 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

Director, Quality Systems

  • Initials: M.P.
  • Location: Mid-Atlantic
  • Therapeutic Areas: Cardiovascular, Infectious Diseases, Rare Disease, Oncology, Pain, Ophthalmology
  • Years of Experience: 20 years of experience in developing processes involving solid orals, sterile, and vialed products, and combination products. Created Master Batch Records and has expert knowledge in Deviation and CAPA. Has built QMS from scratch.
  • Previous Companies: Boehringer Ingelheim, NSF

CMC & Manufacturing


Associate Director, CMC Operations

  • Initials: J.D.
  • Location: West Coast
  • Therapeutic Areas: Autoimmune/Inflammatory, Oncology, Neurology, Rare Disease
  • Years of Experience: 18 years of experience in pharmaceutical drug development, outsourcing, manufacturing, and validation.
  • Previous Companies: Genentech, Various Small Biotechs

Senior Director, Pharmaceutical & Analytical Development

  • Initials: S.J.
  • Location: Greater Boston Area
  • Therapeutic Areas: Oncology, Pulmonary/Respiratory, Vaccines, Rare Disease
  • Years of Experience: Accomplished leader with 25+ years of experience in the biopharmaceutical industry with extensive diversified experience in providing strategic leadership for Analytical Development, Quality Control and CMC for biologics and small molecules. Developing and validating release assays for mAbs, proteins, viral vectors, and small molecules. Authoring CMC sections for regulatory dossiers including IND, IMPD, BLA and NDA (module 3 and module 2), briefing books, annual reports, and correspondences.
  • Previous Companies: Wyeth, Shire

Clinical Operations


Head, Clinical Operations

  • Initials: M.S.
  • Location: Greater Boston Area
  • Therapeutic Areas: Rare Disease, Oncology, Infectious Disease, Hematological, Neurology, Pulmonary/Respiratory
  • Years of Experience: Senior Clinical Operations expert with 15+ years of experience in working with VC-backed biotechs that are in the IND-enabling phase. In-depth Phase 1 oncology experience, performing vendor and site selection, oversight and management of trials.
  • Previous Companies: Several small biotech companies

SVP, Clinical Operations

  • Initials: S.W.
  • Location: Greater Boston Area
  • Therapeutic Areas: Autoimmune/Inflammatory, Infectious Disease, Neurology, Oncology, Rare Disease
  • Years of Experience: Executive clinical trial expert with over 22 years of experience leading clinical teams and setting up trials of various sizes. Extensive experience working with small biotechs newly developing their clinical departments and helping them start their clinical trials.
  • Previous Companies: Pfizer, Kadmon

Data Management, Biostatistics, & Medical Writing


Executive Director, Biostatistics & Data Management

  • Initials: E.K.
  • Location: Greater NY/NJ Area
  • Therapeutic Areas: Cardiovascular, Dermatology, Nephrology, Rare Disease, Endocrine, Pain, Pulmonary/Respiratory
  • Years of Experience: Executive Biostatistician Consultant with 35+ years of experience in the nephrology, cardiology, and pain domains. Well-versed in working on rare disease indications and assisting clients with FDA interactions.
  • Previous Companies: Shire, GSK

Manager, Biostatistician

  • Initials: P.G.
  • Location: Greater Boston Area
  • Therapeutic Areas: Cardiovascular, Hematological, Oncology, Psychiatry
  • Years of Experience: 30+ years experience in biostatistics consulting on statistical, database and programming activities related to clinical trials, developing, reviewing, and finalizing statistical analysis plan, and validating programming deliverables and collaborating with applicable team members on data quality and presentation. Specialties include: Design and analysis of clinical trials, programming, and analysis of large health-care research data sets.
  • Previous Companies: ARIAD Pharmaceuticals, Shire

Medical and Scientific Writer

  • Initials: C.H.
  • Location: West Coast
  • Therapeutic Areas: Rare Disease, Autoimmune/Inflammatory, Cardiovascular, Metabolism, Nephrology. Neurology
  • Years of Experience: 17+ years experience writing preclinical manuscripts for study reports. Worked on IND, pre-IND, NDA applications.
  • Previous Companies: Amgen, Various Small Biotechs