Senior Scientist, Clinical Science IMM

Biopharma Careers; Northern (KY); Hybride; USD 109 000 - 175 000; Plein temps

Avantages offerts par ce poste

Pension plan

401(k) plan

Paid time off

Résumé du poste

Johnson & Johnson is seeking a Senior Clinical Scientist, Clinical Science to support clinical research across therapeutic areas. The role collaborates with physicians, scientists, and cross-functional teams to develop protocols, monitor data, and prepare regulatory documents.

A bachelor’s degree is required, with an advanced degree preferred, and at least 1 year in clinical development. The position emphasizes collaboration in a global matrix environment, travel up to 10%, and proficiency in MS

Qualifications

• Bachelor’s degree in a scientific or related discipline required; advanced degree preferred (MS/PhD).
• 1+ year of relevant clinical research and development experience in pharma/biotech/CRO.
• Familiarity with regulatory guidelines and ICH-GCP; proficient in MS Office; English communication skills.

Responsabilités

• Assist in execution of clinical strategies for protocols within the development plan.
• Support clinical trials: initiation, medical data monitoring, closeout.
• Prepare study documents and regulatory submissions; review data and draft patient narratives for adverse events.
• Collaborate with cross-functional teams and external partners to meet milestones.
• Provide training on study protocols and disease evaluation criteria.

Connaissances

Clinical Data Management

Regulatory & GCP

Data Analysis

Scientific Writing

Communication

Formation

Bachelor's degree in science

MS/PhD preferred

Outils

Excel

Word

PowerPoint

Clinical trial management software

Description du poste

## About this opportunityAt 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.comAs 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.**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 - $174,800.00Additional Description for Pay Transparency:ubject 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 - $175,000This 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 yearSick 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 yearHoliday pay, including Floating Holidays –13 days per calendar yearWork, Personal and Family Time - up to 40 hours per calendar yearParental Leave – 480 hours within one year of the birth/adoption/foster care of a childBereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar yearCaregiver Leave – 80 hours in a 52-week rolling period10 daysVolunteer Leave – 32 hours per calendar yearMilitary Spouse Time-Off – 80 hours per calendar yearFor additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits