Clora’s Top-tier Team

Access Clora’s subject matter experts to support your clinical programs now across Regulatory CMC, Regulatory Affairs, Quality, Data Mgt & Programming, Clinical Pharmacology, Project Mgt, Supply Chain, and Clinical Operations!

Regulatory & CMC

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Director of Regulatory CMC

  • About: 25+ years of experience preparing CMC regulatory strategies and submissions for biologics, combination products, and small molecules, from pre-IND through clinical trials to market applications and post-approval lifecycle. Extensive experience in FDA CMC submission management, including strategy and authoring CMC sections of 20+ INDs, 3 NDAs, 7+ BLAs, and 2 combination product applications. Successful regulatory negotiator with FDA; strong track record of identifying FDA reviewers’ concerns and meeting regulatory expectations with innovative solutions. M.A. in Cell and Molecular Biology.
  • Name: P.K.
  • Years of Experience: 25+ years
  • Location: Northern CA Area
  • Product Modalities: Biologics, Cell Therapy, Recombinant Therapies, Gene Therapy, mABs, ADCs, Small Molecule
  • Therapeutic Areas: Oncology, Immunology, Hematology
  • Previous Companies: BioMarin, Juno Tx, Pfizer, Pharmacyclics, and various small/mid-sized biotechs
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Director of Regulatory CMC

  • About: Seasoned regulatory expert for large, medium and small-sized biotechs and pharmaceuticals. Has broad global experience having managed regulatory teams in Europe, Australia, and the US. Extensive CMC experience and therapeutic experience in oncology, biologics, and other areas. Managed eCTD’s, late and early-stage drug development and had extensive interaction with the FDA, EMEA and other regulatory bodies. Filed several successful NDA’s and MAA’s and numerous other regulatory submissions.
  • Name: E.N.
  • Years of Experience: 25+ years
  • Location: Greater Boston Area
  • Product Modalities: Biologics, DNA & RNA Therapies, Gene Therapy, mABs
  • Therapeutic Areas: Oncology, Rare Diseases, CNS
  • Previous Companies: Genzyme, Shire, Takeda, Translate Bio, and various small/mid-sized biotechs
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Director of Regulatory CMC

  • About: PhD global regulatory affairs leader with over 20+ years of experience. Has led multiple regulatory teams including CMC and Operations successfully. Served as regulatory liaison for regulatory agency interactions for the development of clinical programs and complex regulatory issues including CMC. Accomplished approval of NDAs, sNDAs and MAAs. Successful interactions with the FDA across ODE I-ODEV, OGD, CDRH, DDMAC and other regulatory agencies in Canada and Europe.
  • Name: M.A.
  • Years of Experience: 20+ years
  • Location: NY/NJ Area
  • Product Modalities: Biologics, DNA & RNA Therapies, Cell Therapy, mABs, ADCs
  • Therapeutic Areas: Oncology, Immunology, Rare Diseases, CNS, Vaccines
  • Previous Companies: BMS, Sesen Bio, and various small/mid-sized biotechs

Regulatory Affairs

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Director of Regulatory Affairs

  • About: 5-star rated (3 Clora clients). Accomplished regulatory leader with over 15 years of industry experience in biologic and pharmaceutical development, with an emphasis in oncology and rare disease products. Experienced in global Phase I-III clinical trials, cell, combination and gene therapy products, management of multiple projects simultaneously in a fast-paced environment, orphan designation, fast track designation, CRO management, project management, gap analysis and risk management, and liaison with global regulatory bodies such as FDA, MHRA, EMA and Health Canada.
  • Name: S.Z.
  • Years of Experience: 15+ years
  • Location: Greater Boston Area
  • Product Modalities: Biologics, Combination Products, Cell Therapy, Gene Therapy
  • Therapeutic Areas: Oncology, Anti-inflammatory, Autoimmune Diseases, Rare Diseases
  • Previous Companies: AbbVie, Verastem, Ziopharm, and various small/mid-sized biotechs
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Director of Regulatory Affairs

  • About: Seasoned regulatory leader and strategist. Global experience includes liaising with FDA, Health Canada, and EU submissions and EU MDR. Able to support products from concept to regulatory approval and post marketing supplements, technical file remediation, and collaborating with other departments such as Quality Assurance, Business Development, Management, Clinical, Medical and Marketing to ensure product success. Highlights include 4 INDs, 3 BLAs, 2 EUAs, 20 EU Compassionate Use Applications, 7 NDAs, 4- 510ks, 1 HCTP, 1 PMA, 3 PMA Amendments, 1- 351k, 15 OPDP 2253s, 4 Annuals Reports, 3 PBRER, 2 PSURs, 1 DSUR, 65 EU MDR Technical File Remediations, and 5 483 Remediations.
  • Name: N.A.
  • Years of Experience: 15+ years
  • Location: Southeast Area
  • Product Modalities: Biologics, Combination Products, Cell Therapy, Gene Therapy
  • Therapeutic Areas: Oncology, Cardiology, Women’s Health, CNS, Rheumatology, GI
  • Previous Companies: Regeneron, Valeant, Iterum Tx, Inovio, Bayer, Sanofi, and various small/mid-sized biotechs
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VP/Sr. Director of Regulatory Affairs

  • About: PhD regulatory strategist and leader with 25+ years of experience. Has held different Regulatory and Quality management positions in the biopharma industry covering CMC and clinical trials with extensive experience in coordination, compilation and submission of product BLAs, defining CTD/eCTD structure for product BLAs, preparing a chronology index listing all supplements, noting initial submission contents, and mapping contents to m3 sections. In addition, active in developing, coordinating, and filing applications for national and international registration of drugs, biologics, and devices, along with their amendments and supplements, as well as pre-approval inspection for the products under development and post marketing support for the marketed products while coordinated and developed yearly programs, strategic plans, and annual project budgets. Built and managed teams of up to 60 members.
  • Name: K.A.
  • Years of Experience: 25+ years
  • Location: Southeast Area
  • Product Modalities: Biologics, Cell Therapy, Vaccine
  • Therapeutic Areas: Oncology, CV, Infectious Diseases, Vaccines
  • Previous Companies: Argos, Osiris, Merck, Regeneron, and various small/mid-sized biotechs
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VP/Sr. Director of Regulatory Affairs

  • About: PhD regulatory strategist and leader with almost 20 years of experience. Extensive experience with cell therapies, ADC, small molecules, biologics, drug/device combination products and biomarker development with hands-on experience across a wide range of therapeutic areas including Rare Diseases, Immunology, and Oncology. Hands-on experience in eCTD submission and managing regulatory documents (new INDs and IND amendments, CTAs, Pre-IND, EOP2, Type C meetings, Adaptive Licensing, CHMP Scientific Advice, PMDA consultations, CDE meetings, Orphan Designation, Fast Track, Breakthrough, Pediatric Investigation Plan, BLA, NDA, IB, DSUR etc). Extensive writing experience with clinical protocols, IBs, CSRs, DSURs, Annual Reports, RMPs, Meeting briefing package, and other documents for regulatory submissions. Experience of leading regulatory teams and 30-people projects across US, EU, and Asia
  • Name: P.S.
  • Years of Experience: 20 years
  • Location: Greater Boston Area
  • Product Modalities: Biologics, Cell Therapy, DNA & RNA Therapies, Gene Therapy, mABs, ADCs, Vaccine
  • Therapeutic Areas: Oncology, Immunology, Rare Diseases, Vaccines
  • Previous Companies: Daiichi, Dendreon, Regeneron, and various small/mid-sized biotechs
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Director of Regulatory Project Management

  • About: Top-rated (5 Clora clients). 15+ years of experience in multi-disciplinary life science roles including project management, product development, regulatory, tech ops /engineering, and manufacturing. Has held leadership and consulting roles at top pharmaceutical and medical device organizations. Experience includes hands-on project management of high profile quality systems compliance, integration, product development and IT implementations. Strong skills in communication, strong data analysis, problem-solving skills and achieving project deliverables within negotiated timelines.
  • Name: S.K.
  • Years of Experience: 15+ years
  • Location: Midwest Area
  • Product Modalities: Biologics, Combination Products, Gene Therapy, mABs, ADCs, Small Molecules
  • Therapeutic Areas: Oncology, CV, Immunology, Rare Diseases
  • Previous Companies: Pfizer, J&J, Baxter, GSK, and various small/mid-sized biotechs
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Director of Project Management, Regulatory

  • About: Top-rated (4 Clora clients). 25+ years of experience in multi-disciplinary life science roles including project management, product development, regulatory, tech ops /engineering, and manufacturing. Has held leadership and consulting roles at top pharmaceutical and medical device organizations. Experience includes hands-on project management of high profile quality systems compliance, integration, product development and IT implementations. Strong skills in communication, strong data analysis, problem-solving skills and achieving project deliverables within negotiated timelines.
  • Name: E.W.
  • Years of Experience: 25+ years
  • Location: Greater Boston Area
  • Product Modalities: Biologics, Combination Products, Cell Therapy, Gene Therapy, mABs, ADCs, DNA & RNA Therapies, Small Molecules
  • Therapeutic Areas: Oncology, Hematology, Immunology, Rare Diseases
  • Previous Companies: BMS, J&J, Shire, Spero, and various small/mid-sized biotechs

Quality

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Head of Clinical Quality

  • About: Top-rated (2 Clora clients). Seasoned Clinical Quality Consultant with expertise in the strategic assessment of compliance risk of premarket drug trials. Expertise include GCP and SOP gapassessment, interim GCP/GLP Quality function leadership, inspection readiness, clinical document review, SOP authorship/review and hosting/supporting EMA/FDA BIMO inspections. Track record includes cross-functional and direct management, GCP training, auditing and implementation of riskbased compliance strategies. Auditing includes: site, vendor, document, trial master file (TMF), mock Regulatory Inspections and internal system audits (Data Management and Biometrics, Pharmacovigilance and Medical Monitoring, Clinical Operations, Regulatory Operations and Clinical Supply). Expert at TMF QC and review.
  • Name: K.H.
  • Years of Experience: 15+ years
  • Location: Greater Boston Area
  • Product Modalities: Biologics, Combination Products, Cell Therapy, Drug Delivery
  • Therapeutic Areas: Oncology, Inflammation, Ophthalmology, CV
  • Previous Companies: Avedro, BMS, Shire, Synta, and various small/mid-sized biotechs
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Head of Clinical Quality

  • About: Top-rated (1 Clora client). Accomplished Quality leader with over 20 years of experience. Expertise includes global GCP, GMP, GLP regulations and ISO standards, QMS development and implementation, gap analysis and mitigation, and global QMS, GMP, GLP, GCP, GCLP, GVP and REMS audit expertise.
  • Name: D.S.
  • Years of Experience: 20+ years
  • Location: Mid-Atlantic Area
  • Product Modalities: Biologics, Small Molecules
  • Therapeutic Areas: Oncology, Hematology, Immuno-Oncology, Immuno-Inflammatory, Anti-Infectives, Rare Diseases
  • Previous Companies: J&J, GSK, PRA, and various small/mid-sized biotechs
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Head of Clinical Quality & Operations

  • About: Seasoned leader in biopharmaceutical development, R&D Program and Project Management, Global Clinical Trial Execution, Operational Excellence and Process Improvement; Organizational and Change Management Leadership; Clinical Quality Assurance and Auditing, Quality Management Systems, Systems Excellence, Stakeholder influence and Management, Training and Development. Key accomplishments include 20 new product approvals, eTMF Implementation with One Week Turn-around for visual access, 5 successful clinical development/R&D M&A integrations, Global Quality Leadership Award, 12 successful regulatory inspections (FDA/EMA/MHRA/HC), reduced QA audit findings by 30%.
  • Name: D.S.
  • Years of Experience: 25+ years
  • Location: Greater Boston Area
  • Product Modalities: DNA & RNA Therapeutics, Recombinant Product, Small Molecules, Vaccine
  • Therapeutic Areas: Oncology, Hematology, Immuno-Oncology, Immuno-Inflammatory, Anti-Infectives, Rare Diseases
  • Previous Companies: AbbVie, Karyopharm, Shire, and various small/mid-sized biotechs
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Head of Clinical Quality & Operations

  • About: 5-star rated (4 Clora clients). GCP Quality Assurance and Project Management. Proven record of success implementing technological and operational solutions to clinical operations management, regulatory compliance, Quality System creation, and eTMF services. Highly skilled at managing a large number of projects in multiple countries with an impressive level of expertise. Strong leadership and managerial skills, with the ability to develop and empower cross-functional and culturally diverse team members to achieve peak performance. Additional expertise includes SOP Development, CAPA Process & Resolution, Traditional and Risk Based Monitoring, and GCP/GLP Quality Assurance Auditing.
  • Name: D.S.
  • Years of Experience: 30 years
  • Location: Greater Boston Area
  • Product Modalities: Biologics, Cell Therapy, DNA & RNA Therapeutics, Gene Therapy, Small Molecules, mABs, ADCs, Vaccine
  • Therapeutic Areas: Oncology, Hematology, Immunology, Ophthalmology, Infectious Diseases
  • Previous Companies: Astrazeneca, C4, Pathways Tx, and various small/mid-sized biotechs
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Director of GMP QA

  • About: 5-star rated (1 Clora client). Over 29 years of experience in the pharmaceutical industry with strong Regulatory & Quality leadership including validation, auditing, compliance, analytical and confident interaction with U.S. and international government organizations. Provide expertise guidance for quality system development, regulatory compliance and auditor as a consultant over the last 18 years for domestic and international companies. As Director of Global Compliance and a validation/compliance consultant, has carried out over 3 dozen direct interaction with FDA, Health Canada, EMA, and other regulatory bodies. Primary interface with U.S. and international regulatory agencies and certifying bodies for over two dozen site inspections, presentations, and submissions, as well as matters regarding compliance with quality system requirements, and product problems
  • Name: G.P.
  • Years of Experience: 25+ years
  • Location: Greater Boston Area
  • Product Modalities: Biologics, Cell Therapy, DNA & RNA Therapeutics, Gene Therapy, Small Molecules, mABs, ADCs, Vaccine
  • Therapeutic Areas: Oncology, Hematology, Immunology, Ophthalmology, Infectious Diseases
  • Previous Companies: Astrazeneca, C4, Pathways Tx, and various small/mid-sized biotechs
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Director of GMP QA

  • About: 30+ years of hands on, managerial and consulting experience in Opera-tions, Quality Assurance/Quality Control, and project management of commer-cial cGMP and ISO-9001 process design, process development and contract manufacturing of biologics, biopharmaceuticals, bulk antigens & immunochemicals, sterile fill-finish of liquid parenterals and diagnostic reagents and kits. Over 20 years of expertise, experience and documented achievements in the commercial cGMP bio-manufacturing facility design, construction, validation and turn-key operations in compliance with the FDA, Health Canada and the EU requirements.
  • Name: R.Z.
  • Years of Experience: 30+ years
  • Location: Southeast Area
  • Product Modalities: Biologics, Cell Therapy, Gene Therapy, Recombinant Product, mABs, Vaccine
  • Therapeutic Areas: Oncology, Immunology, CV, GI, Infectious Diseases, Vaccines
  • Previous Companies: Meridian Bio, Roche, Viragen, and various small/mid-sized biotechs

Data Management & Programming

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Clinical Data Manager

  • About: Experience in managing databases and ensuring proper collection of relevant and accurate data. Proficient in the use of clinical industry standard computer programs and applications, as well as a strong track record of EDC system implementation, having worked with a variety of platforms (RedCap, Rave, Inform, IBM Clinical, to name a few), as well as collaboration with cross functional clinical teams to ensure data quality.
  • Name: A.W.
  • Years of Experience: 10+ years
  • Location: Southeast Area
  • Development Phases: Ph I-III
  • Therapeutic Areas: Oncology, CNS, Ophthalmology, CV, Infectious Diseases, Dermatology
  • Previous Companies: Omni Bio, Takeda, and various small/mid-sized biotechs
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Clinical Data Manager

  • About: Over 20 years of experience as a data manager with a focus in Oncology. Has worked for both large and small sponsors. Experience in phase 1 through submission, over 15 years of experience as a lead for both in-house and outsourced studies.
  • Name: M.B.
  • Years of Experience: 20+ years
  • Location: Pacific NW Area
  • Development Phases: Ph I-III
  • Therapeutic Areas: Oncology, Infectious Diseases
  • Previous Companies: Astellas, Genentech, Nektar, and various small/mid-sized biotechs
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Clinical Data Manager

  • About: Highly experienced Clinical Data Manager with over over 25 years of industry expertise. Supported clinical trials in multiple therapeutic areas across Phase I-IV. Worked for both the Pharma and CRO sectors. Expertise in study build development as well as maintenance.
  • Name: J.M.
  • Years of Experience: 25 years
  • Location: Southern California Area
  • Development Phases: Ph I-IV
  • Therapeutic Areas: Oncology, Immunology, Infectious Diseases, Dermatology
  • Previous Companies: Aventis, Pfizer, and various small/mid-sized biotechs
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Statistical Programmer - SAS

  • About: Over 30 years of clinical SAS programming experience including safety and efficacy programming. Collaborated on writing SOPs and programming guidance documents for several companies during my career. While employed at Pfizer Global R&D, managed a cross-functional global team responsible for defining companywide standards for the collection and reporting of clinical data using CDISC standards.
  • Name: J.F.
  • Years of Experience: 30 years
  • Location: Southern California Area
  • Development Phases: Ph I-IV
  • Therapeutic Areas: Oncology, CV, Ophthalmology
  • Previous Companies: Pfizer and various small/mid-sized biotechs
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Statistical Programmer - SAS

  • About: Lead Programmer with a MS degree and 10+ years of experience in the CRO and biotech industry as a SAS Programmer. Strong background across multiple therapeutic areas and have worked across phases I-IV. Currently leading two studies as a Sr. SAS Programmer capacity.
  • Name: J.R.
  • Years of Experience: 10+ years
  • Location: RTP Area
  • Development Phases: Ph I-IV
  • Therapeutic Areas: Oncology, CNS, CV, Ophthalmology
  • Previous Companies: Arcutis, Medimmune, Prometrika and various small/mid-sized biotechs

Clinical Pharmacology

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Head of Clinical Pharmacology

  • About: 4.8-star rated (2 Clora clients). 20 years of innovation experience in US pharmaceutical/biotech. Contributed to development activities of 15+ NMEs (IND/Phase I to NDAs and Global Registration trials). Scientific Advisor for INDdose, an app that calculates the estimated maximum safe starting dose in initial clinical trials for therapeutics in adult healthy volunteers. Part of multiple approved NDA products. Expertise includes leading IND-enabling studies, IND filing, Clinical Pharmacology gap analysis, First in Human Dose calculation, study design, protocol writing, Phase 1, Phase 2 POC and Phase 3 program management, PK/PD/Pop PK strategy and analysis, NDA, sNDA regulatory advice, BA/BE and DDI studies, safety review, Medical and Scientific affairs support, due diligence expertise.
  • Name: A.B.
  • Years of Experience: 20 years
  • Location: NY/NJ Area
  • Product Modalities: Biologic, Combination Product, DNA & RNA Therapeutics, Gene therapy, mABs, Small Molecules
  • Therapeutic Areas: Oncology, Hematology, CV, Infectious Diseases
  • Previous Companies: Cyclerion, Novartis, Roche and various small/mid-sized biotechs
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Head of Clinical Pharmacology

  • About: 5-star rated (1 Clora client). Clinical pharmacologist MD with experience in oncology pharmacology and immunology. 20+ years of experience in drug development from preclinical research through Ph I-III and drug approval. Team leader of large international research groups down to small biotech as well as performing as an individual contributor to produce a number of succesful NDAs. Clinical Pharmacology expertise includes innovative study design, biomarkers, surrogate markers, PK, population PK and modeling, Have served as CMO for 2 biotechs with cell therapy and I/O therapies.
  • Name: A.B.
  • Years of Experience: 20 years
  • Location: NY/NJ Area
  • Product Modalities: Biologic, Cell Therapy, mABs, Small Molecules
  • Therapeutic Areas: Oncology, Immunology, CNS, Metabolic Diseases
  • Previous Companies: Cyclerion, Daiichi, Roche and various small/mid-sized biotechs

Project Management

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Project Manager

  • About: Top-rated (1 Clora client). Seasoned global strategy, portfolio, program, and project management expert. Background in drug development and clinical trial management in biopharmaceutical manufacturing environments. Accomplished in building project management offices (PMOs) from the ground up with all necessary processes, templates, and tools. Trains and leads cross-functional, multi-disciplinary teams end-to-end to complete deliverables within budget and deadline. Knowledgeable in new product development, pre-clinical drug development, regulatory filings, clinical trials (Ph I-III), and best practices. Adept in Agile/Scrum, Waterfall, Kanban, and Lean Six Sigma methodologies. Team player and collaborator with excellent budget, resource, and financial planning skills.
  • Name: D.R.
  • Years of Experience: 25+ years
  • Location: Greater Boston Area
  • Product Modalities: Biologics, Recombinant Products
  • Development Phases: Discovery, Preclinical, Ph I-III
  • Therapeutic Areas: Hematology, Inflammation, Respiratory Diseases
  • Previous Companies: Takeda and various small/mid-sized biotechs
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Project Manager

  • About: 5 star rated (1 Clora client). Strategic C-Level Executive and Advisor with a proven record of driving infrastructure and innovation as a trusted thought partner to biopharmaceutical decision makers. Success achieving milestones and growing innovation portfolios with diverse, cross-functional team engagement. Brings a broad and deep blend of corporate executive, advisory board, and consulting experience for emerging and established biotech companies. Industry knowledge includes strategic portfolio planning, project/program management, business analytics and communications, operations contracting, and productivity optimization. 20+ years of experience in developing operational, strategic and leadership coherence to reach milestones and bring innovation to fruition with diverse teams that enhance overall organizational performance.
  • Name: E.B.
  • Years of Experience: 25+ years
  • Location: Bay Area
  • Product Modalities: Biologics, Cell Therapy, Recombinant Products, Small Molecules
  • Development Phases: Preclinical, Ph I-II
  • Therapeutic Areas: Oncology, Inflammation, Respiratory Diseases, Rare Diseases
  • Previous Companies: Bayer, Origin Bio, Vivacitas Oncology, and various small/mid-sized biotechs
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Project Manager

  • About: Accomplished R&D Project Manager for drug, device and combination products with experience in design control and establishment of business processes and best practices. Expertise includes long term experience managing large, virtual teams, cross-functional team leadership, timeline execution, risk mitigation, & sound program governance, in-depth regulatory & quality systems understanding, and leadership and execution in procurement of external vendors.
  • Name: T.J.
  • Years of Experience: 20+ years
  • Location: Bay Area
  • Product Modalities: Biologics, Cell Therapy, Recombinant Products, Small Molecules
  • Development Phases: Discovery, Preclinical, Ph I-IV
  • Therapeutic Areas: CV, Rare Diseases
  • Previous Companies: Quark, J&J, and various small/mid-sized biotechs

Supply Chain

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Clinical Supply Chain Manager

  • About: 10+ years’ clinical supply in the pharmaceutical drug development business and progressive management experience in forecasting, planning, packaging, and delivering clinical trial materials (IMP and non-IMP) for Phase I-III trials. Experience in global supply logistics operation includes temperature excursion management, maintaining GMP/GCP compliance and export/import classifications (HTSUS, ECCN, Country of Origin), and preparing and auditing clinical documents to comply with regulations of CBP, FDA, USDA, ICH, and GCP. Well versed in IRT, SAP, Agile, Excel, PPT, and Smartsheets
  • Name: K.H.
  • Years of Experience: 10+ years
  • Location: Midwest Area
  • Product Modalities: Biologics, Cell Therapy, Small Molecules, Drug Delivery
  • Development Phase: Ph I-III
  • Therapeutic Areas: Oncology, Inflammation
  • Previous Companies: Nantkwest, RemeGen, and various small/mid-sized biotechs
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Clinical Supply Chain Manager

  • About: 20+ years of progressive accomplishments leading operations, logistics, and project management initiatives. Strong strategic planner, problem solver, and persuasive leader. Committed to managing operations and projects flawlessly while consistently delivering desired results and contributing to revenue producing activities. Experience includes packaging & labeling, vendor selection & management, IRT implementation and management, preparation of regulatory filings, temperature handling, and SOP development
  • Name: K.H.
  • Years of Experience: 20+ years
  • Location: Southern California Area
  • Product Modalities: Biologics, Cell Therapy, Small Molecules, Drug Delivery
  • Development Phase: Ph I-IV
  • Therapeutic Areas: Oncology, Inflammation, CNS, Respiratory, Hematology, Infectious Diseases, Rare Diseases
  • Previous Companies: BMS, Intercept, Novo Nordisk, and various small/mid-sized biotechs
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Clinical Supply Chain Manager

  • About: 5-star rated (1 Clora client). 20 years of industry experience: 8 yrs in manufacturing, 12 yrs in clinical supply chain supporting Ph I-IV trials. Has managed several multi-million dollar inventories as well as saved millions of dollars through various optimization models. Has managed supplies globally, authored and implemented SOPs across CMOs and internal manufacturing partners. Experience also includes packaging & labeling, IRT implementation & management,
  • Name: J.I.
  • Years of Experience: 20+ years
  • Location: Midwest Area
  • Product Modalities: Biologics, Cell Therapy, Gene Therapy, Combination Products, mABs, Small Molecules, Drug Delivery
  • Development Phase: Ph I-IV
  • Therapeutic Areas: Oncology, Inflammation, Immunology, Infectious Diseases
  • Previous Companies: Celgene, Pfizer, Sierra Oncology, and various small/mid-sized biotechs
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Clinical Supply Chain Manager

  • About: 5-star rated (2 Clora client). 25+ years experience in providing clinical supplies for investigational studies worldwide. Experience includes packaging and labeling, understanding of label requirements for multiple countries, import/export requirements, development of IVR specifications and monitoring system for duration of clinical study.
  • Name: J.K.
  • Years of Experience: 25+ years
  • Location: Southeast Area
  • Product Modalities: Biologics, Small Molecules
  • Development Phase: Ph I-IV
  • Previous Companies: Gilead, GSK, and various small/mid-sized biotechs

Clinical Operations

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Clinical Trial Manager

  • About: Experienced, results-driven senior clinical operations consultant with proven pharmaceutical clinical trial experience. A high level of integrity and commitment to Good Clinical Practices, with 15 years of drug development and research experience, in North America and Europe, involving all aspects of clinical trial management, clinical monitoring, budget creation and negotiation, study document writing and editing. Strong written and verbal communication skills and adept at interpreting clinical and scientific data and presenting clinical information for multiple and diverse audiences.
  • Name: S.M.
  • Years of Experience: 15+ years
  • Location: Ontario, CN
  • Development Phases: Ph I-IV
  • Therapeutic Areas: Oncology, Immunology, Respiratory Diseases, Infectious Diseases
  • Previous Companies: Monte Rosa Tx, H3 Bio, and various small/mid-sized biotechs
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Clinical Trial Manager

  • About: Over 25 years of experience in the clinical research and pharmaceutical industry. The last 10+ years have been supporting biotech and small pharmaceutical companies in delivering oncology trials. Has managed trials in all phases I, II, III, and IV trials, which includes the implementation of study protocols, research development/bench science, first in human, immuno-oncology, autologous cancer vaccine, cell therapy, gene therapy, master protocols (basket trials) and pediatric trials across North America, Asia Pacific, and Europe in multiple indications.
  • Name: A.S.
  • Years of Experience: 25+ years
  • Location: Texas/SW Area
  • Development Phases: Ph I-IV
  • Therapeutic Areas: Oncology, Immunology, Hematology, Respiratory Diseases, Infectious Diseases
  • Previous Companies: AstraZeneca, PPD, and various small/mid-sized biotechs