PCP Pharmaceutical Industry & Education Fellow – Johnson & Johnson Biotherapeutic Drug Product & Clinical Trial

Time Type:
Full time

This 2-year Biotherapeutic Drug Product & Clinical Trial Development fellowship program provides the fellow with an opportunity to work on new modalities and technologies within the Drug Product Development & Delivery function of Johnson & Johnson. The fellow will be integrated into a team of scientists and engineers to engage in the development of new biologic and combination drug products using hands‑on, laboratory‑based techniques.

The fellow will also work alongside a Trial Delivery Leader to plan and execute clinical trials. This fellowship prepares individuals to pursue a career in the pharmaceutical industry. Weekly responsibilities are split between Saint Joseph’s University (20%) and Johnson & Johnson (80%). The fellow will successfully complete projects related to industry, the fellowship program, and teaching responsibilities. It is expected that as the fellow progresses through the program, the individual will be able to practice with increasing levels of independence.

• Develop and cultivate core skills and competencies in analytical reasoning, critical and strategic thinking, problem solving, communication, influencing, and teamwork.
• Develop professional responsibility and enhance leadership presence.
• Enhance interpersonal communications with healthcare providers, strategic business partners, and consumers.
• Strengthen ability to critically evaluate, interpret, synthesize, and communicate scientific information.
• Instill knowledge of laws, compliance regulations, and guidance’s pertaining to medical and regulatory affairs.
• Advance critical thinking skills through industry‑based projects and cross‑functional teamwork.
• Strengthen leadership and professionalism through participation in academic and industry initiatives.
• Apply and communicate clinical knowledge to projects and project teams.

Industry-based Responsibilities:

• Plan and lead an innovative 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, manufacturing process development, ancillary compatibility andin-use stability, and delivery feasibility and dose accuracy.
• Author technical reports, maintain electronic laboratory notebooks, and communicate project findings.
• Leverage clinical and pharmacy expertise to optimize drug product preparation and administration approaches and instructions, identify patient risks, and address unique challenges in biologic drug delivery.
• Conduct literature searches and present updates on current clinical practices to scientific colleagues to encourage a patient and provider‑centric approach to the drug development process.
• Support the development of study‑specific documents, plans, and manuals.
• Assist in trial regulatory submissions and interactions, such as protocol amendments and responding to health authority and ethics committee Requests for Information.
• Participate in medical monitoring of clinical trial data and identifying trends in patient outcomes.

Clinical Trial Development:

• Support the development of clinical trials, with opportunity to gain exposure to various phases of end‑to‑end trial execution (planning, start‑up, execution, data analysis, reporting, and closure).
• Work with the cross‑functional trial team to build and deliver the trial operational plan, identifying and mitigating risks to effectively deliver assigned trials on time, on budget,…