JamesSPartyka

Summary

• You will find I'm a multifaceted pharmaceutical professional and innovator with a proven record of successes spanning the Pharmaceutical, Biotechnology, Hospital and Academic Industries; with over 20 years immuno-oncology patient care, teaching, clinical research, and medical affairs experience; knowledge in writing clinical research and regulatory documents. I have a broad background in financial reporting with budget preparations, managing monthly and annual spend. I've been successful in trial management delivering high quality results within budget and I'm proficient in medical writing for protocols, informed consents, INDs, study reports, presentations and manuscripts.
  
  I was the Founding Director of the Clinical Trials Office and the Oncology Pharmacy Residency program at H. Lee Moffitt Cancer Center in Tampa, Florida.
  
  I am a Board Certified Pharmacotherapy Specialist (BCPS) and a Registered Pharmacist in the state of Florida.
  
  A few of my key accomplishments include:
  
  ★ Clinical Lead for the Marketing Authorization Application and the successful approval of Adcetris (brentuximab vedotin)
  
  ★ Founder of Pharmative, a Global Medical Communications Company for Patients, Scientists and Healthcare Professionals
  
  ★ Global Publication Lead for Nexavar (sorafenib)
  
  ★ Clinical research and / or product commercialization support for cabozantinib, CC-122, neratinib, brentuximab vedotin, TAK-441, sorafenib, motesanib, panitumumab, pegfilgrastim, filgrastim, darbepoetin alfa, palifermin, romiplostim, denosumab, and topotecan.