Senior Scientist, Clinical Science IMM

Johnson Johnson; Spring House (PA); On-site; USD 110,000 - 160,000; Full time

Job summary

Johnson & Johnson is seeking a Senior Clinical Scientist, Clinical Science, to support clinical research within the therapeutic area. You will collaborate with physicians, scientists and cross-functional teams to develop protocols, monitor data, and prepare regulatory documents.

Requirements include a bachelor’s degree in a scientific field, 1+ year in clinical research, and strong English communication. Advanced degrees and AI/trial-management tools are a plus. Travel up to ~10% may be required.

Qualifications

• Minimum Bachelor's degree in a scientific or related discipline.
• Advanced degree (MS, PharmD, PhD) preferred.
• At least 1 year of relevant clinical research experience.
• Understanding of regulatory guidelines and ICH-GCP.
• Proficiency with Microsoft Office; familiarity with AI and trial management software advantageous.
• Excellent written and verbal English; strong communication.
• Ability to work in cross-functional, global matrix teams.

Responsibilities

• Assist in developing clinical trial protocols and study materials.
• Review medical data and draft patient narratives for adverse events.
• Collaborate with Study Responsible Physicians/Scientists and cross-functional teams.
• Support medical data monitoring and reporting per the plan.
• Provide training on study protocol, disease criteria, and development processes.
• Liaise with CROs and external partners to support trials.
• Review relevant medical literature to support trial execution.

Skills

Communication skills

Teamwork

Time management

Analytical thinking

Problem solving

English proficiency

Education

Bachelor's degree in a scientific or related discipline

Advanced degree (MS, PharmD, PhD) preferred

Tools

Microsoft Office

Clinical trial management software

AI familiarity

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Clinical Development & Research - Non-MD

Job Category:

Scientific/Technology

All Job Posting Locations:

Spring House, Pennsylvania, United States of America

Job Description:

Senior Clinical Scientist, Clinical Science

Position Summary

The Senior Clinical Scientist, Clinical Science is responsible for supporting clinical research activities within the Therapeutic area. This position involves close collaboration with Study Responsible Physicians, Study Responsible Scientists, Clinical Leads, and other cross-functional team members to contribute to the development and execution of clinical studies. Responsibilities include supporting the development of clinical trial protocols and study materials, performing medical data review, and assisting in the preparation of clinical study reports and regulatory documents. This role requires effective collaboration within a matrixed organizational structure, emphasizing strong communication and teamwork across diverse disciplines to support the successful execution of clinical trials.

Essential Job Duties and Responsibilities

• Assist with the execution of clinical strategies for clinical trial protocols of the clinical development plan, ensuring compliance with scientific, organizational and regulatory standards.
• Assist to support clinical trials, including study initiation, medical data monitoring, and closeout activities.
• Assist with providing training on study protocol, disease evaluation criteria, and other essential components to enhance the understanding of clinical development processes.
• Collaborate with Study Responsible Scientists and Study Responsible Physicians to review aggregate and participant-level data, analyze clinical laboratory results, and draft patient narratives for adverse events within the context of study endpoints.
• Support medical data monitoring activities in partnership with Study Responsible Scientist and Study Responsible Physician, including the evaluation, documentation, and reporting of ongoing clinical trial data per defined medical data review plan.
• Collaborate with cross-functional partners to support clinical strategies with overall product development goals.
• Develop and maintain relationships with internal and external stakeholders, including cross-functional trial teams, and external partners/vendors (e.g. CRO).
• May review relevant medical literature in support of clinical trial execution.

Education and Experience

• A minimum of a bachelor's degree in a scientific or related discipline is required.
• An advanced degree (e.g., MS, PharmD, PhD) is preferred.
• Requires at least 1 year of relevant experience in clinical research and development within the pharmaceutical industry, biotech, CRO, or equivalent.
• Understanding of regulatory guidelines and Good Clinical Practice (ICH-GCP).
• Ability to survey and interpret scientific literature related to specific projects effectively.
• Proficiency in Microsoft Office Suite, especially Excel, Word, and PowerPoint, and familiarity with generative artificial intelligence and clinical trial management software are advantageous.
• Excellent written and verbal communication skills in English; ability to effectively present information to the stakeholders.
• Strong interpersonal skills with a collaborative approach to working within cross-functional and global matrix teams.
• Good organizational skills with the ability to multi-task and prioritize assignments.
• Proven analytical and problem-solving capabilities, with a detail-oriented mindset.
• Ability to proactively identify study level issues/discussions that require escalation.
• Ability to handle study projects and meet deadlines, even under pressure.
• Strong project and time management skills.
• Willingness to travel domestically and internationally, approximately 10%, as required by project needs.
• A commitment to maintaining high ethical standards and fostering a culture of inclusivity in the workplace.

Preferred Skills:

Clinical Data Management, Clinical Evaluations, Coaching, Critical Thinking, Data Savvy, Drug Discovery Development, Ethical and Participa