Perrigo Fellowship

St. John's University & Perrigo Pharmaceuticals
Post-Doctoral Pharmaceutical Industry Fellowship in Clinical Affairs

About Perrigo Pharmaceuticals

Based in Allegan, Michigan, U.S.A., Perrigo Company is a leading global healthcare supplier that develops, manufactures and distributes OTC and generic prescription (Rx) pharmaceuticals, infant formulas, nutritional products, active pharmaceutical ingredients (API) and pharmaceutical and medical diagnostic products. The Company is the world's largest manufacturer of OTC pharmaceutical products for the store brand market.

The Company is noted for its focus on best in class innovation leading to more OTC ANDA approvals than any other competitor. Since 1976, Perrigo Company has participated in 80% of prescription to over the counter medication conversions. Additionally, Forbes Magazine has named Perrigo as one of the 100 fastest growing companies two years running. The Company currently has over 2700 products available in more than 70 countries worldwide. It is estimated that the use of these products have saved consumers more than $10 billion over the past 15 years.

Fellowship Objectives

The two year fellowship program at Perrigo is designed to provide an in-depth development and learning opportunity for a Doctor of Pharmacy graduate with career interest in the Clinical Affairs discipline.  This pharmaceutical industry fellowship is designed to develop and expand the fellow’s skills to effectively practice in Clinical Affairs in the Pharmaceutical Industry.

The program will provide hands-on learning and independent research associated with designing and executing clinical trials and will include: Project Management of Phase I - IV clinical trials, protocol development, participation in cross functional efforts necessary for the drug development process, and Good Clinical Practice (GCP).  It will also provide a broad exposure to the pharmaceutical product pipeline in the emerging Generic Pharmaceutical arena, working on cross-functional projects with Perrigo’s Global Scientific Affairs Organization. 

Additionally the fellow will enhance his/her knowledge through educational and research activities at St. John’s University.

Program Structure

Perrigo Company
The Fellow will be exposed to a variety of areas within the Pharmaceutical Research & Drug Development structure and responsibilities with a main focus on Clinical Affairs.  The following is a summary of activities/outcomes.

The Fellow will spend their time in a project management capacity with various responsibilities to maximize their knowledge of the overall clinical affairs function and grow their overall expertise in the profession.  The Fellowship will be designed with a combination of hands-on participation with Clinical Affairs Experts; managing and implementing a major value-added project or initiative; conducting and applying research; and participating in cross-functional project teams within the company.

Perrigo will provide the Fellow with the opportunities, materials, and resources necessary to conduct required activities.  Preceptors will guide the Fellow on a daily basis.

Key components of the curriculum at Perrigo

1.   Hands-on Learning and Cross Functional Engagement

• Receive mentoring from Clinical Affairs Project Managers (PMs) and follow them on Clinical Endpoint (CEP), Pharmacokinetics (PK), Pharmacodynamics (PD), VCA and dermal safety studies. Learning outcome: Develop clinical trial design and management, strategic planning, and problem solving skills.
   
• Engage in cross functional collaboration on product development, clinical design and regulatory strategy and approval. Learning outcome: Drug development process & challenges, Improved communication skills, learning to influence without authority, risk mitigation and quality, budget development and management, and integration into Global teams and Global functions.

2.   Formal Training

• Day to Day in depth engagement in programs, strategic planning and cross functional teams
• Internal & External Project Management training opportunities
• Good Clinical Practice (GCP) and Good Manufacturing Practices (GMP) internal training
• Clinical Affairs standard operating procedures internal training
• In-vitro in-vivo correlation (IVIVC) and different models of research internal training

Learning Outcome: Understanding of drug development process and challenges; familiarity with Code of Federal Regulations and FDA issued Guidance’s, Trial Design & Modeling, standard operating procedures; and risk mitigation planning.

3.   Independent Learning

• Literature review (publications, summary basis of approval (SBA), package insert (PI), guidance’s, Industry tools/websites, etc.) for:
  a. Product evaluation
  b. Protocol development
  c. Specific clinical questions

• Preparation of an upcoming program:
  a. Define processes
  b. Ensure compliance with Code of Federal Regulations and Guidances
  c. Learn and utilize Managed Service Providers (MSP) software

St. John’s University, College of Pharmacy and Health Sciences

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

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 Health Sciences and Perrigo Pharmaceuticals Company.

ELIGIBILITY FOR FELLOWSHIP

To be eligible, candidates must be graduates of an 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.
 

APPLICATION PROCESS

Interested candidates should send:

How To Apply 

Please send all correspondence (electronic and hardcopy) to:

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