Clinical Development Fellowship

The fellow will function as a clinical scientist and will support medical directors/senior level clinical scientists on the following activities:

• Serve as a clinical science representative on cross-functional sub-teams (i.e., protocol execution, clinical, biomarkers, pharmacokinetics)
• Create, review and present clinical slides for internal (i.e., BeOne) and external meetings (e.g. Investigator meetings, scientific congresses, advisory boards, site visits, site staff training)
• Develop understanding of Good Clinical Practice (GCP), International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), FDA, EMA, NICE and other relevant guidelines and regulations
• Draft abstracts, posters, manuscripts for scientific meetings
• Author and review of clinical documents (i.e., clinical trial protocols, clarifications and amendments, informed consents, investigator brochures, clinical study reports, investigational new drug submissions)
• Respond to inquiries from health authorities (e.g., FDA, EMA) and study site ethics committees
• Partner with the data management team to assist with the development of case report forms
• Serve as a primary point of contact for study inquiries
• Contribute to ongoing review of the integrity of clinical trial data
• Develop understanding of the entire clinical development process from Phase I-IV

Clinical Development (Hematology) Leadership

Amit Agarwal, M.D., Ph.D.
Chief Medical Officer,
Hematology

Remus Vezan, MD, Ph.D.
Vice President,
Clinical Development, Hematology

Toay Foster-Ortiz, M.A.O.M.
Executive Director,
Chief of Staff to Hematology Chief Medical Officer (CMO)

Fellowship Program Steering Committee

Sheel Patel, PharmD
Director, Clinical Science

Charity Henrich, PharmD
Senior Manager, Clinical Science

Wai Chan, Ph.D.
Senior Director, Clinical Science

Candidates must have earned a PharmD from an ACPE accredited college of pharmacy before the start of the fellowship term. Candidates must be legally authorized to work in the United States at the time of hire and must maintain valid work authorization for the duration of the fellowship. University of the Pacific does not provide immigration sponsorship (e.g., H-1B petitions or green card sponsorship) for fellowship positions. All candidates must satisfy applicable employment eligibility verification (Form I-9) requirements.

Candidates must submit via email (pharmfip@pacific.edu) all the following application materials by the deadline listed on the University’s website:

• Letter of intent
• Updated curriculum vitae (CV)
• Three (3) letters of recommendation emailed directly from the letter writer
  • Please address letters of recommendation and letters of intent to:
    Sachin A. Shah, PharmD, FACC, FAHA
    Director, Fellowship in Industry Program
    Professor of Pharmacy Practice
• One professional writing sample that demonstrates medical writing ability
• Unofficial pharmacy school transcript emailed to FIP director

Timelines

• For application timelines, please refer to the University of the Pacific Fellowship in Industry Program Website.

For any questions, please contact pharmfip@pacific.edu