PCP Pharmaceutical Industry & Education Fellow – Johnson & Johnson Biotherapeutic Drug Product & Clinical Trial Development (2 year)

Position Title:

Time Type:

Position Summary and Qualifications:

NOTE - ABOUT UPLOADS

All applicants should include the ALL of following attachments into the Resume/CV field of their application: a letter of intent; a curriculumvitae; unofficial college transcripts both undergrad and professional; a document listing (3) references with their name degree(s) title email address and phonenumber for each reference; and a writing sample (e.g. example of drug information response; other non-peer reviewed materials are acceptable. No posters slide presentations group activities or peer reviewed publications). The online application system only allows for 5 total attachments please consider this as you upload your attachments.

Fellowship Objectives

• 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 guidances 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.
• Essential Duties & Responsibilities

Industry-based Responsibilities:

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 manufacturing process development ancillary compatibility product stability delivery feasibility and dose accuracy
• Author technical reports maintain laboratory notebooks and present project findings
• 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
• 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 clinical trial with opportunity to gain exposure to various phases of end-to end trial execution (planning start-up execution data analysis reporting and closure)
• Support 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 and in a compliant manner
• Additional responsibilities may include but are not limited to:
  • Supporting the development of study-specific documents plans and manuals
  • Assisting with external vendor selection and set-up including ensuring that scope of work and specifications are consistent with protocol requirements budget and timelines
  • Supporting risk identification and mitigation strategy creation and roll-out within a clinical trial
  • Working with internal partners to assist in management of activities such as country and site feasibility
  • Assisting in trial regulatory submissions and interactions such as protocol amendments and responding to health authority and ethic committee Requests for Information
  • Collaborate across all members of the cross-functional team including members from clinical operations clinical pharmacology biostatistics regulatory affairs and data management
  • Participating in medical monitoring of clinical trial data and identifying trends in patient outcomes
  • Supporting other activities as delegated by the study team

*Pharmacy licensure is required by September 1st 2026

University-based Responsibilities:

• Completion of a one-year teaching certificate program with responsibilities for didactic and experiential teaching and a continuing education (CE) presentation for pharmacists
• Actively participate in professional development seminars and workshops designed to enhance professional growth and leadership
• Contribute to the successful functioning of the fellowship program such as facilitating student outreach recruitment marketing social media team building etc.

Secondary Duties & Responsibilities

As a training program all the duties and responsibilities are considered primary and necessary for successful completion of the fellowship.

Minimum Qualifications

Required:

• Doctor of Pharmacy degree from an ACPE-accredited college of pharmacy (by the start of the fellowship program)
• It is expected that the fellow will be able to commute to both the university and the company to fulfill fellowship requirements.

Preferred:

• Computer skills: Microsoft Office email and calendar proficiency
• Sufficient technology aptitude to learn new technology systems including virtual conferencing if necessary
• Medical writing proficiency
• Communication skills including formal presentations
• Ability to work cross-functionally with a diverse team

Physical Requirements

This position does not require lifting or pulling as part of the day-to-day activities.

Unusual Work Hours

• Throughout the year there will be periodic times when the fellow will be responsible for attending conferences webinars or meetings outside the usual work hours either in the evenings or on the weekends.
• Travel may be required to represent the fellowship at various recruitment sessions such as university career fairs and professional conferences.

Required Documents: see NOTE at the top of this posting

• Curriculum vitae / resume
• Letter of intent
• Example of drug information response (other non-peer reviewed material is acceptable)
• Unofficial transcript(s)
• Contact information for 3 references

Saint Josephs University is a private Catholic Jesuit institution and we expect members of our community to be knowledgeable about and to make a positive contribution to our mission. Saint Josephs University is an equal opportunity employer that seeks to recruit develop and retain a talented and diverse workforce. The University is committed to the diversity of its faculty and staff so that our students our disciplines and our community as a whole can benefit from the multiple perspectives it offers. The University seeks qualified candidates who share our commitment to equity diversity and inclusion. EOE

Saint Josephs University prohibits discrimination on the basis of sex in its programs and activities including admission and employment in accordance with Title IX of the Education Amendments of 1972. The Title IX Coordinator is responsible for overseeing compliance with Title IX and other civil rights laws and regulations. To contact the Title IX Coordinator e-mail visit Campion Student Center suite 243 or call . To learn more about the Universitys Title IX policies the process for filing a report or formal complaint of sex discrimination sexual harassment or other form of sexual misconduct and the Universitys response to reports and/or formal complaints please visit Inquiries may also be directed to the Federal agency responsible for enforcing Title IX the U.S. Department of Education Office for Civil Rights.

Pay Transparency & Benefits Overview

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