Job Function:
Discovery & Pre-Clinical/Clinical Development
Job Sub Function:
Clinical Development & Research 64 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 bachelors 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:
ubject to the terms of their respective plans, employees are eligible to participate in the Companys 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 Companys 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 60 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado 68 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 60 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
