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 investigational drug trial design and management 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.
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, study-responsible 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
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
Provide effective communication with other fellows and team members on supported projects
Investigational Drug Trial Execution (~6 months)
Fellow will work to support the operational aspects of at least one complex Early Development Investigational Drug study, with variation across all phases of a trial (planning, start-up, execution, data analysis, reporting and closure).
Fellow will work in support of the Global Operations Head (GOH), Global Program Leader (GPL), and Global Trial Leader (GTL) to ensure successful cross-functional delivery of the assigned global clinical trial within agreed timelines and budget and in alignment with all applicable SOPs and regulatory requirements.
Fellow responsibilities may include but are not limited to:
External service selection and set-up, including ensuring that scope of work and specifications are consistent with protocol requirements, budget, and timelines.
Tracking of project deliverables & timelines using functional planning tools.
Transparent communication across all members of the cross-functional
Creation and update of study-specific documents such as Monitoring Guidelines, Informed Consent Form(s), IMP related documentation, and safety related documents.
Support of risk identification and mitigation strategy creation and roll-out.
Support of study training creation and roll-out (at central, local, and site level).
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
Other activities as delegated by the investigational drug trial management team.
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 who progress to the final round of interviews will be provided additional information on how to formally apply to the position after the interview at Midyear. This will be completed through the Janssen Application Portal.
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.
About Janssen Research and Development & 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.