Title: Clinical Development Postdoctoral Fellowship
If you are interested in the below position, please send your resume to [email protected] and REFERENCE THE POSITION TITLE within the subject line.
Duration: Up to 24 months
Start Date: June 27, 2022
This two-year fellowship offers an opportunity to gain extensive experience within Clinical Development at a fast-paced, innovative, patient centric, biopharmaceutical company focused on developing and delivering therapies for patients with B-cell diseases. Through the TG Therapeutics fellowship program, the fellow will develop and strengthen core competencies that are key to a successful career within the biopharmaceutical industry. These competencies include technical and foundational capabilities as well as strategic and analytical thinking and project planning. Attention to detail and the ability to deliver results effectively and efficiently as well as strong communication and presentation skills are also refined throughout a 2-year fellowship at TG Therapeutics. In addition, building a strong drug development acumen in combination with scientific expertise and regulatory knowledge will bolster the fellow’s versatility and ability to succeed as a biopharmaceutical professional.
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.
Over the course of 2 years, fellows will experience a comprehensive training program with gradual development of skills and technical capabilities. The first year focuses on establishing a solid foundation in the clinical development process. The second year offers the fellow to assume more responsibility and contribute independently on projects with the option to rotate across different functional areas that complement drug development. The following is a snapshot of what can be expected in the 1st and 2nd years of the fellowship:
––Developing an understanding of regulatory documents and processes
––Acquiring a mastery of therapeutic disease areas, pipeline assets, and competitive compounds
––Assist with summarizing clinical data for publications, conference materials, etc.
––Managing competitive intelligence resources for senior management
––Reviewing regulatory submissions and trial documents (i.e. IND, IB, protocol) ensuring accuracy and consistency
––Presenting on a related drug development topic to department and other key stakeholders
––Authors sections of clinical trial documents (IBs, protocol, etc.)
––Contributes to trial design discussions
––Authors sections of regulatory submissions (i.e. Breakthrough Therapy Designation requests)
––Analyzes patient-level clinical data providing context with metrics reported for competitive compounds
––Takes ownership of generating content for assigned congress presentation
––Optional: One to two 3-month rotations in other areas of interest.
PharmD by May 2022 from a US accredited program