Clora’s Top-tier Oncology Experts

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

Preclinical Development

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Director, Preclinical and Translational Development

  • Initials: C.P.
  • Location: California
  • Therapeutic Areas: Hematological, Oncology, Vaccines
  • Years of Experience: 20+ years of experience in preclinical and clinical management of a wide-variety of cell and gene therapy products that advanced into clinical studies. Products in development have included the first commercial sponsored gene therapy product, the first oncoloytic virus enrolled into pivotal clinical trials, the first modified cell product for the treatment of Parkinson’s Disease and cancer stem cell targeting monoclonal antibody used in clinical trials
  • Previous Companies: Previously held positions in academia – Cell Therapy Translational Laboratories (CTTL) and several startup immuno-oncology companies.
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Director, Toxicology

  • Initials: M.T.
  • Location: California
  • Therapeutic Areas: Autoimmune/Inflammatory, Cardiovascular, Gastrointestinal, Metabolism/Nutrition, Oncology, Allergy/Immunology
  • Years of Experience: Board certified regulatory toxicologist with over 20 years experience in the biopharma industry. Extensive experience with a variety of biologic modalities including monoclonal antibodies, immunomodulators, bi-specifics, Fc and other fusion proteins, antibody-drug conjugates, cytokines/interleukins, protein replacement therapies, nanoparticles, CAR-T cells, and vaccines
  • Previous Companies: Previously held positions at Pfizer and Amgen.

Clinical Development and Medical Affairs

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Senior VP, Clinical Development

  • Initials: F.R.
  • Location: New York
  • Therapeutic Areas: Allergy/Immunology, Oncology, Rare Disease
  • Years of Experience: 20 years in biopharma from the pre-clinical stage to Phase I-IV development. Deep experience with biologics, CAR-T therapies, and involvement with over 25 immuno-oncology IND and BLA submissions.
  • Previous Companies: Previously roles leading the oncology pipeline at J&J, Celgene, Bayer, and several small biotechs focused on precision medicine.
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Senior Medical Director

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

Drug Development Consultant

  • Initials: B.H.
  • Location: Florida
  • Therapeutic Areas: Allergy/Immunology, Oncology, Hematological, Pediatrics, Autoimmune/Inflammatory
  • Years of Experience: 20+ years experience in Clinical Development, with specific expertise in bone marrow transplantation and cell/gene therapies.
  • Previous Companies: Previously held positions at Pharmacyclics, and various small/mid-sized biotechs

Regulatory Affairs and Quality Assurance

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Vice President, Regulatory Affairs

  • Initials: A.M.
  • Location: NC
  • Therapeutic Areas: Infectious Disease, Virology, Oncology, Pediatrics
  • 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
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VP, Quality Assurance

  • Initials: R.M.
  • Location: New England
  • Therapeutic Areas: Autoimmune/Allergy, Immunology, Oncology
  • Years of Experience: 20+ years experience in Quality Assurance, with expertise in GXP regulations, quality systems, risk management, and SOP development. 
  • Previous Companies: Previously held positions at Boston Scientific, Genzyme and various small/mid-sized biotechs

CMC/Manufacturing

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Director, CMC and Manufacturing

  • Initials: T.T.
  • Location: Southwest
  • Therapeutic Areas: Oncology, Psychiatry, Women’s Health OB/GYN
  • Years of Experience: Highly experienced pharma professional with nearly 30 years of experience in Operations, CMC, Supply Chain, and Regulatory projects. RAC certified and CMC lead on two recently approved drugs. Experience with biologics, small molecule drugs, and non-sterile oral dosage.
  • Previous companies: ALZA, Various Biotech
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VP, CMC

  • Initials: A.S.
  • Location: New England
  • Therapeutic Areas: Oncology, Immunology/Allergy, Vaccines
  • Years of Experience: Ph.D. Chemist, Pharmacist and Biologist with 34 years of experience in quality affairs and drug product manufacture. Expertise in drug product development and aseptic processing-sterile formulations across a number of product technologies (small molecules, proteins, peptides, cell and gene therapy)
  • Previous Companies: Previous positions have been focused in small stage oncology companies

Clinical Operations

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Senior Clinical Project Manager

  • Initials: D.S.
  • Location: New England Area
  • Therapeutic Areas: Infectious Disease, Oncology, Vaccines, Cardiovascular, Immunology
  • Years of Experience: 25+ years experience in Clinical Operations, including management of global phase I-IV oncology clinical trials
  • Previous Companies: Previously held positions at Vertex, AstraZeneca, and Boston Scientific
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Director, Clinical Operations

  • Initials: M.S.
  • Location: New England Area
  • Therapeutic Areas: Infectious Disease, Cardiovascular, Oncology
  • Years of Experience: 25+ years experience in Clinical Operations, successfully building clinical operations departments and deep expertise in vendor oversight, GCP auditing, US and EU regulatory submissions, and BIMO inspections
  • Previous Companies: Previously held positions at Millennium, Biogen, and Sepracor (Sunovion)

DM / Stats / MW

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Senior Clinical Data Manager

  • Initials: R.C.
  • Location: New England
  • Therapeutic Areas: Oncology, Nephrology, Musculoskeletal
  • Years of Experience: 20+ years experience in Data Management, working on early to late phase studies for Oncology programs
  • Previous Companies: Previously held positions at Takeda, Biogen and various small/mid-sized biotechs
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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
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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