Janssen Pharmaceuticals, Inc.

Biotherapeutic Drug Product & Clinical Trial Development Fellowship

Pharmaceutical Companies of Johnson & Johnson
Locations: Malvern & Spring House, PA
Recruiting: 1 Position for a 2-Year Fellowship

The fellowship will include elements of formulation, manufacturing, delivery design, and strategy for novel biologics including antibody, cell, and gene therapies. Additionally, fellows will gain experience in early-stage clinical trial development.

Janssen Research and Development, part of the Johnson & Johnson family of Companies, aims to transform individual lives and fundamentally change the way diseases are managed, interpreted, and prevented. At Janssen, we strive to foster a diverse, equitable, and inclusive environment consistent with our Credo values to bring out the highest potential of each contributing individual. 

The Biotherapeutic Drug Product & Clinical Trial Development fellowship program provides the fellow with an opportunity to work on new modalities and technologies within Biotherapeutics Drug Product Development & Delivery. The fellow will be integrated into a team of scientists, engineers, and pharmacists to engage in the development of new biologic and combination drug products using hands-on, laboratory-based techniques. The fellow will also work alongside the global trial development team to plan and execute early-stage clinical trials. We are recruiting one fellow for this program to begin in 2024.

This fellowship offers a two-fold experience in which the fellow will be exposed to the following:

Biotherapeutic Drug Product Development (~75% of experience)

• Plan and lead a research project that meaningfully contributes to scientific understanding and business needs
• Design and execute laboratory-based studies that support drug development activities and regulatory filings, such as formulation and excipient selection, ancillary compatibility, product stability, delivery feasibility, and dose accuracy 
• Utilize pharmacy knowledge to provide clinical insight on preparation and administration techniques that impact instructional training for investigational sites
• Identify areas of risks to patients based on preparation and administration strategies to ensure positive outcomes in clinical trials
• Collaborate with scientists to optimize drug products, and engage with cross-functional team members to address complex formulation, manufacturing, and delivery challenges
• Author technical reports, maintain laboratory notebooks and present project findings
• Conduct literature searches and present updates on current clinical practices to scientific teams to incorporate a patient and provider-centric approach to the drug development process 

Clinical Trial Development (~25% of experience)

• Support the development of at least one complex early development drug study, with variation across all phases of a trial (planning, start-up, execution, data analysis, reporting, and closure) 
• Collaborate with multi-functional groups (primary investigators, study responsible scientists, trial leaders, etc.) to ensure successful cross-functional delivery of the assigned global clinical trial
• Additional responsibilities may include but are not limited to:
  • Authoring study-specific documents to be used during patient recruitment and clinical trial start-up
  • Assisting with external vendor selection and set-up, including ensuring that scope of work and specifications are consistent with protocol requirements, budget, and timelines  
  • Coordinating and participating in internal and external study specific meetings as necessary to document outcomes, actions, and decisions
  • Supporting risk identification and mitigation strategy creation and roll-out
  • Working with internal partners to assist in management of activities such as country and site feasibility
  • Ensuring that trial activities are consistent with global regulations and requirements
  • Establishing transparent communications across all members of the cross-functional team
  • Supporting other activities as delegated by the investigational drug trial management team

*Pharmacy licensure is required by September 1st, 2024