The Clinical Development Fellowship program is designed to provide hands-on experience across the drug development process spanning Investigational New Drug (IND) submissions to New Drug Application (NDA) / Biologics License Application (BLA) filings. Under the mentorship of the Fellowship Preceptor and senior leadership, the fellow will have the opportunity to undertake key responsibilities within Clinical Development, including (but not limited to):
- Summarizing disease areas and therapeutic landscapes for regulatory filings (NDA/BLA)
- Providing scientific rationale for clinical trial protocols
- Contributing to trial design process
- Developing content for Investigator Brochures
- Preparing data for Data Safety Monitoring Board review
- Analyzing clinical safety and efficacy data for publications and conference presentations
- Developing congress materials: abstract submissions and poster/oral presentations
- Leading competitive intelligence initiatives
As the fellow achieves competency in the Clinical Development department, they will have the opportunity to gain experience in other functional areas of interest, such as but not limited to Medical Affairs, Medical Information, Regulatory Affairs, Drug Safety, Pharmacovigilance Operations and Quality.
Requirement: A Doctor of Pharmacy degree from an ACPE-accredited college of pharmacy with strong academic track record completed by May 2022.
Legal U.S. employment eligibility - TG Therapeutics will not be sponsoring applicants for work visas as this time.
TG Therapeutics was founded in 2012 with one goal in mind: to leverage significant advances in the understanding of B-cell tumor biology to create the best possible treatment options for patients with B-cell diseases. TG has about 300 employees, 5 medicines in development, and 35 clinical trials. The TG team is fiercely focused on patients!