Infectious Disease Clinical Support

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

Preclinical Development

\

VP, Preclinical Development and Pharmacology

  • Initials: A.B.
  • Location: New York
  • Therapeutic Areas: Cardiovascular, Hematological, Infectious Disease, Neurology, Pain, Pediatrics, Pulmonary/Respiratory
  • Years of Experience: 20+ years as a leader in clinical pharmacology, primarily working on small molecule therapeutics. Has been a part of multiple approved NDA products for both neurological, infectious disease and hematological indications.
  • Previous Companies: Previously held positions at Novartis and The Medicines Company
\

VP, Pharmacology

  • Initials: A.N.
  • Location: West Coast
  • Therapeutic Areas: Autoimmune/Inflammatory, Cardiovascular, Endocrine, Infectious Disease
  • Years of Experience: Strong clinical pharmacology background and familiarity with analytic tools ensuring 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: Previously held positions at Allergan and Bayer Healthcare

Clinical Development

\

Sr. Vice President, Clinical Development

  • Initials: T.L.
  • Location: Bay Area
  • Therapeutic Areas: Infectious Disease, Autoimmune/Inflammatory, Cardiovascular
  • Years of Experience: 25+ years experience in Clinical Development and Medical Affairs, and already has experience supporting a COVID project
  • Previous Companies: Previously held positions at J&J, Catalyst, and various small/mid-sized biotechs
\

Chief Medical Officer

  • Initials: R.H.
  • Location: NJ
  • Therapeutic Areas: Infectious Disease, Virology, Autoimmune/Inflammatory
  • Years of Experience: 20+ years experience in Clinical Development, leading product development teams in the Virology and Infectious Disease space, as well as small molecules
  • Previous Companies: Previously held positions at BMS, Gilead, and various small/mid-sized biotechs

Program Management

\

Sr. Director Portfolio & Program Management

  • Initials: E.C.
  • Location: Boston Area
  • Therapeutic Areas: Infectious Disease, Virology, Pulmonary/Respiratory, Autoimmune/Inflammatory
  • Years of Experience: 25+ years experience in Program Management, managing clinical stage vaccine and oncology programs, including the management of CMC and Supply Chain functions
  • Previous Companies: Previously held Program Management positions at Pfizer, Allergan, and various small/mid-sized biotechs
\

COO/VP, Program Management

  • Initials: K.S.
  • Location: NC
  • Therapeutic Areas: Infectious Disease, Vaccines
  • Years of Experience: 25+ years experience in Program Management, leading product development teams (preclinical, clinical, regulatory, CMC) to establish comprehensive drug development plans for product types ranging from Vaccines, AAV, and gene therapy
  • Previous Companies: Previously held Program Management positions at Pfizer, Covance, and various small/mid-sized biotechs

Regulatory Affairs

\

Vice President, Regulatory Affairs

  • Initials: A.M.
  • Location: NC
  • Therapeutic Areas: Infectious Disease, Virology
  • Years of Experience: 35+ years experience in Regulatory Affairs for drug and biologic products in a wide range of therapeutic areas, submitting over 100 INDs and NDAs
  • Previous Companies: Previously held positions at GSK and various small/mid-sized biotechs
\

Director, Regulatory Affairs

  • Initials: C.D.
  • Location: PA
  • Therapeutic Areas: Infectious Disease
  • Years of Experience: 30+ years experience in Regulatory Affairs, including being responsible for the development and implementation of the US regulatory strategy for a vaccine portfolio at GSK
  • Previous Companies: Previously held positions at GSK and various small/mid-sized biotechs
\

Sr. Director, Regulatory Affairs

  • Initials: R.L.
  • Location: PA
  • Therapeutic Areas: Infectious Disease, Immunology
  • Years of Experience: 20+ years experience in Regulatory Affairs, on top of 20 years of experience as a Research Scientist, with a focus on small molecule programs
  • Previous Companies: Previously held positions at AstraZeneca and various small/mid-sized biotechs

CMC/Manufacturing

\

Director, Manufacturing

  • Initials: T.R.
  • Location: Midwest
  • Therapeutic Areas: Infectious Disease, Immunology, Oncology, Vaccines
  • Years of Experience: 20+ years as an expert and leader in R&D, process development and commercialization (manufacturing) of mammalian and microbial processes for production of biopharmaceuticals (API, MAbs, vaccines, therapeutic proteins, cell therapies, enzymes)
  • Previous Companies: Eli Lilly and GSK
\

VP, CMC and Product Development

  • Initials: P.W.
  • Location: Southwest
  • Therapeutic Areas: Gastrointestinal, Infectious Disease, Metabolism, Nutrition, Oncology, Pain
  • Years of Experience: 30+ years of expertise in guidance of chem-pharm development strategies from pre-clinical/Phase I through NDA preparation and commercialization. Specialties in outsourcing strategies, IND/NDA CMC document preparation, cGMP, and M&A/licensing due diligence
  • Previous Companies: Previously held positions at Millennium, Biogen, and Sepracor (Sunovion)

Clinical Operations

\

Director, Clinical Operations & Project Management

  • Initials: D.S.
  • Location: New England Area
  • Therapeutic Areas: Infectious Disease, Vaccines, Cardiovascular, Immunology
  • Years of Experience: 25+ years experience in Clinical Operations, including management of a Vaccine clinical trial during the Ebola pandemic
  • Previous Companies: Previously held positions at Vertex, AstraZeneca, and Boston Scientific
\

Director, Clinical Operations

  • Initials: M.S.
  • Location: New England Area
  • Therapeutic Areas: Infectious Disease, Virology
  • Years of Experience: 25+ years experience in Clinical Operations, including management of a global influenza clinical trial
  • Previous Companies: Previously held positions at Millennium, Biogen, and Sepracor (Sunovion)
\

Sr. Clinical Project Manager

  • Initials: J.P.
  • Location: PA
  • Therapeutic Areas: Infectious Disease, Vaccines
  • Years of Experience: 20+ years experience in Clinical Operations with a focus on designing and implementing customized lean operations models to optimize the end-to-end drug development process
  • Previous Companies: Previously held positions at Pfizer and various small/mid-sized biotechs

DM / Stats / MW

\

Vice President, Data Management

  • Initials: K.M.
  • Location: FL
  • Therapeutic Areas: Infectious Disease, Vaccines
  • Years of Experience: 40+ years experience in Data Management, working on early to late phase studies for Infectious Disease, Vaccine and Oncology programs
  • Previous Companies: Previously held positions at ICON, Synteract, and various small/mid-sized biotechs
\

Vice President, Biostatistics & Data Sciences

  • Initials: D.F.
  • Location: PA
  • Therapeutic Areas: Infectious Disease, Oncology
  • Years of Experience: 25+ years experience in Biostats, Programming, and CDM, working on anti-infectives and oncology programs with three successful NDA’s
  • Previous Companies: Previously held positions at ViroPharma (Shire), Merck, and various small/mid-sized biotech
\

Director, Medical Writing

  • Initials: K.N.
  • Location: New England Area
  • Therapeutic Areas: Infectious Disease, Neurology, Oncology
  • Years of Experience: 25+ years experience in Medical and Technical Writing, with a strong focus on regulatory submissions
  • Previous Companies: Previously held positions at Genzyme, Quintiles, and various small/mid-sized biotechs