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Biologics Product Development & Investigational Drug Trial Design and Management Fellowship

The fellowship includes elements of formulation and process development as well as investigational drug trial design & trial management for biologics.

Janssen

The Pharmaceutical Company 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 & Investigational Drug Trial Management 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 (DPD). The Fellow will have an opportunity to work with the investigational drug trial design and execution group on the design and execution of an investigational drug study from conception to execution.  

Biologics Product Development & Investigational Drug Trial Design and Management (2 years)

The two-year Biologics Product Development & Investigational Drug Trial Design and Management fellowship offers two unique rotations that enable fellows to advance and apply skills in biologic drug product development and management of investigational drug trials.   

Biologics Product Development (18-months)

Fellow responsibilities may include but are not limited to:

  • Provide support in the areas of drug product design, dosage preparation, administration and instructional training.
  • Support the collaboration with DPD Formulation Scientists, Global Trial Mangers, Study Responsible Physicians, Study Managers and Pharmacists to ensure that drug preparation and administration can be flawlessly executed at investigational sites for Phase 1 to Phase 3 clinical studies.
  • Support the creation of workflows for drug product in-use stability and compatibility studies.
  • Support the creation of Investigational Product Preparation and Administration Procedures and associated training materials for use at investigational study sites.
  • Support the creation, execution and reporting of In-Use Drug Studies.
  • Support studies to develop optimal formulation for drug products.
  • Support studies to evaluate the manufacturing process of drug product formulations.
  • Assist in technology transfer of drug product and process to fill/finish sites.
  • Author/review technical reports documenting results and conclusions from formulation 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 team
    • 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.

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

Current Fellow

Joseph Weidman, PharmDJoseph Weidman, PharmD
University of Pittsburgh, Class of 2020
First Year Fellow
JWeidman@ITS.JNJ.com  

 

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