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Biologics Product Development & Clinical Trial Design and Execution Track (Two years)

The fellowship will include elements of formulation & process development and clinical trial design & execution for biologics. 

Janssen Research and Development

Pharmaceuticals Companies of Johnson & Johnson
Malvern & Spring House, PA 

Janssen R&D, part of the Johnson & Johnson family of Companies, aims to transform individual lives and fundamentally change the way diseases are managed, interpreted and prevented.  

The Biologics Product Development & Clinical Trial Design and Execution fellowship program provides fellows 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 the clinical study from conception to execution.   

Biologics Product Development & Clinical Trial Design and Execution (2 years) 

The two-year Biologics Product Development & Clinical Trial Design and Execution fellowship offers two unique rotations that enable fellows to advance and apply skills in biologics drug product development and execution in the clinical trials.   

Biologics Product Development (18-months) 

  • Provide support in the areas of drug product design, dosage preparation, administration and instructional training. 
  • Support the collaboration with DPD Formulation Scientists, Global Trial Managers, Clinical Physicians, Study Managers and Pharmacists to ensure that drug preparation and administration can be flawlessly executed at clinical sites for Phase 1 to Phase 3 clinical studies.
  • Support the creation of workflows for drug product in-use stability/compatibility studies.
  • Support the creation of IPPIs (Investigational Product Preparation Procedures) and associated training materials for use at clinical study sites.
  • Support the creation, execution and reporting of Pharmacy Manual Studies.
  • Support studies to develop optimal formulation for drug products (NMEs).
  • Support studies to evaluate processability of drug product formulations. Perform studies to evaluate process design space. Assist in technology transfer of drug product formulation 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.
  • Enhance interpersonal communications.

Clinical Trial Execution (6-months) 

  • Fellow will work to 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).  
  • Fellow will work in support of the Global Operations Head (GOH), Global Program Leader (GPL), and Global Trial Leader (GTL) to track study timelines and budget, to support protocol and country feasibility, site selection, trial and vendor set-up, study execution and trial closure.  
  • Fellow responsibilities may include but are not limited to:
  • Assist in study specific document creation and ancillary supply management, including ordering, distribution, and tracking
  • Ensure the current study status and tracking of trial related information is always available in the appropriate clinical trial management system(s) (CTMS). 
  • Support study coordination activities and tracking of study timelines and study deliverables to ensure trial delivery according to the agreed upon timelines/milestones.
  • Support running Global Clinical Development Organization (GCDO) dashboards & metrics reports with option 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 medication related activities e.g. shipment tracking for non IWRS trials, coordination of relabeling, recall, product quality compliant, and Temperature out of Range (TOR) management and follow-up.
  • 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 GOH, GPL, GTL.

*Pharmacy licensure is required by September 1st for first-year 

Contact:

James M. Hollands, PharmD, BCPS
Director, Industry and Education Fellowship Programs

Address:

University of the Sciences, Philadelphia College of Pharmacy
Box 34
600 South 43rd Street
Philadelphia, PA 19104-4495

Phone:

215-596-8882

Email:

j.hollands@usciences.edu