Senior Scientist, Clinical Science IMM

jj; Pennsylvania; On-site; USD 109,000 - 175,000; Full time

Benefits offered by this job

401(k) plan

Long-term incentive program

Vacation & leave benefits

Job summary

Johnson & Johnson seeks a Senior Clinical Scientist in Clinical Science to support clinical research within the Therapeutic area. You will work with Study Responsible Physicians and scientists to develop protocols, review data, and prepare regulatory documents for submission.

The role emphasizes collaboration in a matrixed environment, medical data review, and preparation of clinical study reports, with travel up to 10% domestically and internationally.

Qualifications

• Bachelor’s degree in a scientific or related discipline is required.
• An advanced degree (MS/PhD/PharmD) is preferred.
• 1+ year of relevant experience in clinical research and development in pharma/biotech/CRO.
• Understanding of regulatory guidelines and GCP (ICH-GCP).
• Excellent written and verbal communication skills in English.

Responsibilities

• Assist with execution of clinical strategies and protocol development.
• Support clinical trials including initiation, monitoring, and closeout activities.
• Provide training on study protocols and disease evaluation criteria.
• Collaborate with stakeholders to review data and draft patient narratives for adverse events.
• Support medical data monitoring and reporting as per plan.
• Coordinate with cross-functional teams and external partners (CROs).

Skills

Clinical Data Management

Clinical Evaluations

Critical Thinking

Data Savvy

GCP

Project Management

Communication Skills

Education

Bachelor's degree in a scientific field

Advanced degree preferred (MS/PhD/PharmD)

Tools

MS Office

CTMS

Clinical trial management software

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.
• 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).

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.

Required Skills:

Preferred Skills:

Clinical Data Management, Clinical Evaluations, Coaching, Critical Thinking, Data Savvy, Drug Discovery Development, Ethical and Participant Safety Considerations, Good Clinical Practice (GCP), Industry Analysis, Medicines and Device Development and Regulation, Regulatory Affairs Management, Relationship Building, Research Documents, Safety-Oriented, Scientific Research, Standard Scientific Processes and Procedures, Technologically Savvy

The anticipated base pay range for this position is :

$109,000.00 - $174,800.00

Additional Description for Pay Transparency:

subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

The anticipated pay range for this position is $109,000 - $175,000

This position is eligible to participate in the Company’s long-term incentive program.

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits