Daiichi Sankyo Fellowship

St. John's University & Daiichi Sankyo Inc.
   Post-Doctoral Industry Fellowship

About Daiichi Sankyo, Inc.

Daiichi Sankyo, Inc. is the U.S. subsidiary of Daiichi Sankyo Co., Ltd, a global pharmaceutical company with headquarters in Tokyo. Our goal is to improve patient lives through the development of high-quality pharmaceutical products and we do this by drawing upon the scientific expertise of our researchers a swell as the creative talents and diverse thinking of all our global employees.

Program Objectives

This two year post Pharm. D. pharmaceutical industry fellowship is designed to develop and expand the fellow’s skills to effectively practice in the pharmaceutical industry.The program provides a broad understanding of the global drug development process and assists each fellow’s understanding of the key role that regulatory affairs has in the Drug Development Process, including the opportunity to gain “hands on” experience concerning the requirements to develop, approve and market new medications. Additionally, the fellow will enhance his / her knowledge through educational and research activities at St. John’s University.

Fellowship Structure

This fellowship is designed to focus in the area of Regulatory Affairs. Below is a summary of activities and outcomes by program year. 

Year One

• At least one full year spent within the Regulatory Affairs department at DSPD which is based in the Edison, New Jersey office
• Work with preceptors and other regulatory functional leaders in Regulatory Affairs (CMC, FDA liaison, Regulatory Operations, Labeling Group) to develop skills and understanding of the regulations (federal /local) required to file and maintain INDs, NDAs primarily in the U.S.
• Acquire a working knowledge of global / international requirements(ICH Guidances, local / regional regulationsi.e. EMA, PMDA, etc) to support the conduct of clinical studies (pre and post marketing) with a global focus
• Participate on an International Project Team (IPT) to support global studies for registration
• Develop the necessary skill set to provide project teams with rational and scientifically driven regulatory strategic guidance for all phases of drug development
• Participate via project teams on large multi-national Phase 3 registration trials and Life Cycle Managemen tprograms
• Attend national scientific conferences, medical meetings, FDA Advisory Committee meeting, and key opinion leader meetings
• Prepare and present poster / abstracts/scientific papers
• Collaborate cross-functionally with global colleagues and scientists, representing diverse backgrounds, knowledge, and expertise on a varietyof issues and topics

Year Two

Rotate (3-6 months) through various departments at DSPD, dependent on fellow’s level of interest and / or projects with a high priority level within the organization.
Rotations may include but not be limited to:

• Translational Medicine and Clinical Pharmacology
• Clinical Pharmacovigilance and Drug Safety
• Clinical Development (several therapeutic areas)
• Project Management

St. John’s University Component

Each fellow will have opportunities at the University to participate in activities to promote professional development including:

• Formal and informal educational opportunities
• Collaborative research projects with St. JohnUniversity’s faculty
• Development of continuing education courses
• Resident and fellow seminar series with the College of Pharmacy and Health Professions
• On-campus teaching opportunities within the Doctor of Pharmacy Program
• Graduate degree programs available at the University to further his or her educational development (Master’sor PhD degrees)
• Individual research project(s)

Benefits

The fellowship provides a competitive stipend and a benefit package, including comprehensive health insurance through St. John’s University.

Certificate of Completion

Upon successful completion of the fellowship program, a certificate of completion will be awarded by St. John’s University College of Pharmacy and Allied Health Professions and Daiichi Sankyo Pharma Development.
 
Eligibility Requirements

To be eligible, candidates must be graduates of an Accreditation Council forPharmacy Education (ACPE) accredited Doctor of Pharmacy Program before July 1 of the fellowship term and have a strong interest in a career in the pharmaceutical industry. Participation in the American Society of Health-Systems Pharmacists (ASHP) Midyear Clinical Meeting / PPS is strongly encouraged, but not required

HOW TO APPLY

Please send all correspondence (electronic and hardcopy) to:

 Joseph Brocavich, Pharm.D.
Associate Dean for Pharmacy Programs
Associate Clinical Professor
College of Pharmacy and Allied Health Professions
St. John’s University
8000 Utopia Parkway
Queens, NY, 11439
Email:  brocavij@stjohns.edu