BIOLOGICS PRODUCT DEVELOPMENT & CLINICAL TRIAL DESIGN AND EXECUTION FELLOWSHIP
Janssen Research and Development
Janssen Research and Development is partnering with the Philadelphia College of Pharmacy (PCP) at University of the Sciences (USciences) to offer a two-year product development and clinical trial design and execution fellowship focused on biologics. The fellow will divide their time between their Janssen (80%) and USciences (20%) responsibilities. This fellowship is based out of the company's Malvern and Spring House, PA facilities. We are recruiting for one (1) fellow for 2020.
This fellowship provides the fellow with an opportunity to work on new modalities and technologies to create new drug products within Janssen Biologics Drug Product Development. The fellow will have an opportunity to work with the Clinical Trial Design and Execution Group to work on the design and execution of a clinical study from conception to execution.
FELLOWSHIP PROGRAM OBJECTIVES
Develop and cultivate core skills and competencies in analytical reasoning, critical and strategic thinking, problem solving, communication, influencing, and teamwork.
Advance professional responsibility and enhance leadership presence.
Enhance interpersonal communications with healthcare providers, strategic business partners, and consumers.
Instill knowledge of laws, compliance regulations, and guidance documents pertaining to functional role
Develop critical thinking and enhance clinical knowledge from industry-based projects and cross-functional teams.
Strengthen leadership and professionalism through participation in industry and academic initiatives.
Apply and communicate clinical knowledge to projects and project teams.
Biologics Product Development (~18 months)
Provide support in the areas of drug product design, dosage preparation, administration and instructional training
Support the collaboration with Drug Product Development Formulation Scientists, Global Trial Managers, clinical physicians, study managers, and pharmacists to ensure that drug preparation and administration can be executed in Phase 1 to Phase 3 clinical studies
Support the creation of workflows for drug product in-use stability/compatibility studies
Support the creation of Investigational Product Preparation Procedures and associated training materials
Support the creation, execution and reporting of Pharmacy Manual Studies
Support studies to develop optimal formulation for drug products
Support studies to evaluate ability to process drug product formulations
Perform studies to evaluate process design space
Assist in technology transfer of drug product formation and process to fill/finish sites
Author/review technical reports documenting results and conclusions of formulating and process development studies
Clinical Trial Execution (~6 months)
Support the operational aspects of at least one complex early development clinical study, with variation across all phases of a trial: planning, start-up, execution, data analysis, reporting and closure
Work with Global Operations Head, Global Program Leader and Global Trial Leader to track study timelines and budget, to support protocol and country feasibility, site selection, trial and vendor set-up, study execution and trial closure
Assist in study specific document creation and ancillary supply management, including ordering, distribution and tracking
Ensure current study status and tracking of trial-related information is always available in appropriate clinical trial management system
Support study coordination activities and tracking of study timelines and study deliverables to ensure trial delivery according to the agreed upon timelines and milestones
Support running Global Clinical Development Organization dashboards and metrics reports with options to provide status analysis
Coordinate and participate in internal and external study specific meetings as necessary, and document outcomes, actions and decisions; follow-up to resolution when required
Support quality oversight and inspection readiness activities
Work with internal partners to assist in management of activities such as country and site feasibility
Completion of a one-year teaching certificate program with responsibilities for didactic and experiential teaching and a continuing education (CE) presentation.
Participate in professional development seminars and workshops designed to enhance professional growth and leadership.
BENEFITS AND COMPENSATION
Benefits and compensation are provided through Janssen
PPS Interview Request
Interested candidates should submit a request for an interview through the PPS portal with their CV and a letter of intent. Candidates selected for an interview will be notified by email with the interview date & time.
Online Application Portal
Candidates with a continued interest in the program must submit an online application through the Janssen Application Portal. In addition, please submit the following items electronically through the portal or via mail/email to the address listed below:
Letter of intent
Three (3) letters of recommendation
Unofficial transcript(s) for all college coursework
James M. Hollands, PharmD, BCPS Fellowship Program Director PCP/USciences Mailbox 34 600 S. 43rd Street Philadelphia, PA 19104-4495 Pharmafellows@usciences.edu
Have or anticipate receiving a Doctor of Pharmacy degree from an ACPE-accredited college of pharmacy by the start of fellowship.
Obtain pharmacist licensure by September 1st
Demonstrate strong written and verbal communication skills
Communicate a strong interest in pursuing a career in the pharmaceutical industry.
Internal Number: JANP-002
About Philadelphia College of Pharmacy / University of the Sciences
Philadelphia College of Pharmacy is the first pharmacy school in the nation and part of the University of the Sciences. The Department of Pharmacy Practice and Pharmacy Administration is dedicated to educating students in pharmacy, conducting research, and performing service to advance the University, the profession, and society.