Clora’s Top-tier Consultants

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

Preclinical Development


Vice President, Preclinical Development & Pharmacology

  • Initials: A.B.
  • Location: New York Area
  • Therapeutic Areas: Cardiovascular, Hematological, Infectious Disease, Neurology, Pain, Pediatrics, Pulmonary/Respiratory
  • Years of Experience: Leader in clinical pharmacology for over 20 years primarily working on small molecule therapeutics. Has been a part of multiple approved NDA products for both neurological and hematological indications.
  • Previous Companies: The Medicine Company, Novartis

Vice President, Preclinical & Clinical Development

  • Initials: A.N.
  • Location: West Coast
  • Therapeutic Areas: Autoimmune/Inflammatory, Cardiovascular, Endocrine, Infectious Disease, Neurology, Ophthalmology
  • Years of Experience: Strong clinical pharmacology background with over 20+ years of experience. Familiarity with analytic tools ensures pharmacologically-driven protocol, program design and analysis. Designed and managed multiple first-in-human studies, Phase I supportive studies, POC, dose response studies, and demonstration of efficacy studies including large scale Phase II evaluations.
  • Previous Companies: Allergan, Bayer

Clinical Development & Medical Affairs


Executive Director

  • Initials: W. H.
  • Location: Pacific NW
  • Therapeutic Areas: Gastrointestinal, Hematological, Neurology, Oncology
  • Years of Experience: Scientific Executive with 20+ years of experience, who consistently delivers on the critical responsibility of translating pharmacological actions of drugs into FDA approvals.Leader of project teams of up to 50 through direct or matrixed reporting relationships. Multiple IND and new chemical entity applications and approvals, including International experience (Europe, Canada, Australia, Japan).
  • Previous Companies: Eisai, Small Biotech

Executive Medical Director

  • Initials: B. R.
  • Location: New York Area
  • Therapeutic Areas: Infectious Disease, Neurology, Oncology, Pediatrics, Vaccines
  • Years of Experience: Broad experience in Clinical Development and Clinical Pharmacology across many therapeutic areas over a 20+ year career. Participated in 7 NDAs, 3 sNDAs, and more than 10 INDs and inventor on 17 issued patents. Clinical trial physician on studies conducted in US, Europe, Japan, Latin America and South Africa. He has primarily spent his career in smaller biotechs, where he had to take the lead in trial design and protocol development.
  • Previous Companies: Novartis, Purdue Pharma Small Biotech

Manager, Medical Affairs

  • Initials: R.X.
  • Location: West Coast
  • Therapeutic Areas: Cardiovascular, Endocrine, Gastrointestinal, Nephrology, Oncology, Pain
  • Years of Experience: Medical affairs manager with 14+ years of experience. Expertise lies in bringing clinical research projects from concept to completion and generate scientific evidence that helps physicians, patients and positively impact business using critical thinking skills and a data-driven approach.
  • Previous Companies: Eli Lilly, Boston Scientific

Regulatory Affairs & QA


Director, Regulatory Affairs

  • Initials: T.C.
  • Location: West Coast
  • Therapeutic Areas: Autoimmune/Inflammatory, Neurology, Oncology, Ophthalmology
  • Years of Experience: Regulatory expert with over 28+ years of experience. Global regulatory lead for projects that spanned all phases of development (pre IND thru post marketed projects) at 4 major pharmaceutical companies.
  • Previous Companies: Bristol-Myers Squibb, Biogen

Manager, Quality Assurance/Control

  • Initials: M. P.
  • Location: Mid Atlantic/DC
  • Therapeutic Areas: Cardiovascular, Infectious Disease, Oncology, Ophthalmology, Pain
  • Years of Experience: Throughout his 20+ year career, he has worked with EDMS Master Control, and is adept with this document management system. He is comfortable reviewing and approving Master Batch Records, Deviations, and CAPA, as showcased by implementing an entire QMS system with previous clients. He has worked with GCP guidelines as well, including reviewing clinical trial data. During his career, he has worked on hematological cancers as well as gene therapies for rare diseases. In addition to working for large pharmaceutical companies like Pfizer and Merck, he has worked in smaller companies and understands working with a small team.
  • Previous Companies: Boehringer Ingelheim, Merck, Small Biotech

CMC & Manufacturing


Director, Supply Chain

  • Initials: O. L.
  • Location: New York Area
  • Therapeutic Areas: Neurology, Oncology, Pain, Pediatrics, Pulmonary/Respiratory, Women’s Health OB/GYN
  • Years of Experience: Experience leading cross-functional project teams from preclinical to post-approval stages with organizations from start-ups to the world’s largest pharma companies across a 20+ year career. A results-oriented leader with a strong technical background, who develops highly competent, productive organizations. Proven success devising creative solutions to business problems and scientific challenges. Extensive experience in building external alliances and vendor relationships to deliver projects on time and within budget. Achieved multiple NDAs/MAAs, sNDA, and first-to-file P4 ANDA approvals; saved a company a human study.
  • Previous Companies: Merck, Small Biotech

Director, CMC Manufacturing

  • Initials: S.J.
  • Location: Greater Boston Area
  • Therapeutic Areas: Oncology, Pulmonary/Respiratory, Vaccines
  • 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


Director, Clinical Operations

  • Initials: A.W.
  • Location: Greater NY/NJ Area
  • Therapeutic Areas: Musculoskeletal, Pulmonary/Respiratory, Women’s Health OB/GYN
  • Years of Experience: 25+ years experience leading clinical operations across a range of medical devices and therapeutic areas. Has managed all aspects of clinical trials including trial site protocol adherence, patient recruitment, site selection, and overseeing data collection and analysis.
  • Previous Companies: Several small biotech companies

Director, Clinical Operations

  • Initials: M.D.
  • Location: Midwest
  • Therapeutic Areas: Cardiovascular, Musculoskeletal, Nephrology, Neurology, Pediatrics, Pulmonary/Respiratory
  • Years of Experience: 18+ years experience managing global clinical drug development programs and their regulatory processes through leadership of the operational design, implementation and execution of clinical trials. Device and Biologics experience.
  • Previous Companies: Smiths Medical, Various Small Biotechs

Data Management, Biostatistics, & Medical Writing


Data Manager

  • Initials: B.R.
  • Location: West Coast
  • Therapeutic Areas: Dermatology/Plastic Surgery, Neurology, Pain, Pediatrics, Urology
  • Years of Experience: 28+ years experience in Data Management. Responsible for oversight of studies where data management was completely outsourced and for supervision of internal data managers within the CRO Management Group. Specialities: Clinical Data Management and Best Practices, Data Quality, Inspection Readiness.
  • Previous Companies: Pfizer, Allergan

Head of Data Management

  • Initials: E. K.
  • Location: New York Area
  • Therapeutic Areas: Cardiovascular, Dermatology/Plastic Surgery, Endocrine, Nephrology, Pain, Pulmonary/Respiratory
  • Years of Experience: Previously worked in CRO’s setting, large pharma, small biotech, and medium biotech managing biostatistics and data management departments and providing strategic clinical development advice over a 25+ year career. For the last 4 years, they have been providing professional biostatistics and strategic advice mainly to start-up and small to medium biotech companies. The advice spans from exploratory studies, through phase I-IV, and post-marketing commitments.
  • Previous Companies: GlaxoSmithKline, Small Biotech

Manager, Medical Writing

  • Initials: J.W.
  • Location: New York Area
  • Therapeutic Areas: Cardiovascular, Endocrine, Gastrointestinal, Hematological, Infectious Disease, Metabolism/Nutrition, Nephrology, Neurology, Pulmonary/Respiratory, Urology, Women’s Health OB/GYN
  • Years of Experience: 10 years of medical writing/project/trial management experience and 8 years regulatory expertise. Identified designs, developed, and managed multiple large execution and ongoing research programs with phase I-IV. Supervised assigned staff, provided scientific leadership, and proficient in IND/NDA/BLA submissions.
  • Previous Companies: Pearl Therapeutics (AstraZeneca)