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

Position Title:

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

Time Type:

Full time

Position Summary and Qualifications:

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.

All applicants should include the following attachments into the "Resume/CV" field of their application: a letter of intent; a curriculum vitae; unofficial college transcripts, both undergrad and professional; a document listing (3) references with their name, degree(s), title, email address and phone number for each reference; and a writing sample (eg, example of drug information response; other non-peer reviewed materials are acceptable). 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 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.

Essential Duties & Responsibilities

Industry-based Responsibilities:

Biotherapeutic Drug Product Development (~75% of experience)

• •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

Clinical Trial Development (~25% of experience)

• •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, and in regulatory compliance
• •Additional opportunities include:
• •Supporting the development of study-specific documents, plans, and manuals

Assisting in trial regulatory submissions and interactions, such as protocol amendments and responding to health authority and ethics committee Requests for Information

Participating in medical monitoring of clinical trial data and identifying trends in patient outcomes

University-based Responsibilities:

• •Completion of a one-year Teaching and Learning Curriculum 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.
• •Pharmacist licensure is required by September 1, 2027

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

• •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 Joseph’s 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 Joseph’s 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 Joseph’s 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 titleix@sju.edu, visit Campion Student Center suite 243, or call 610-660-1145. To learn more about the University’s 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 University’s response to reports and/or formal complaints, please visit www.sju.edu/titleix