Job Function: Discovery & Pre-Clinical/Clinical Development
Job Sub Function: Clinical Development & Research - Non-MD
Job Category:Scientific/Technology
All Job Posting Locations:Colorado Springs, Colorado, United States of America, West Chester, Pennsylvania, United States of America
Job Description:SECTION 1: JOB SUMMARY*On behalf of the Medical Device Group, this clinical research professional will be responsible for the development of clinical evidence generation and dissemination strategies (EGS/EDS) across assigned New Product Development (NPD) and Life-Cycle Management (LCM) projects.
SECTION 2: DUTIES & RESPONSIBILITIES*Under limited supervision, and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
- Contributes to the development and deliver appropriate Global EGS / EDS to support NPD and LCM within the assigned platforms, with collaborative relationships with all relevant Clinical R&D partners and cross-functional partners (R&D, Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics and Market Access).
- Ensures input and strong alignment from key regional MD Clinical R&D leads and other strategically important countries/regions in the development of the EGS / EDS.
- Develops and draft clinical trial protocols, informed consents, investigator brochures, and other study materials with minimal supervision.
- Plans for study budgets and collaborate with Clinical Operations to manage the development of Investigator agreements and site contracts within fair market value (FMV), vendor agreements, payments, and financial disclosures.
- Is responsible for delivery of assigned clinical programs, through effective partnership with the Clinical Operations and BSDM teams, to enable optimized engagement leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOP).
- Develops strong collaborative relationships with the study core team and others to ensure study progress for assigned projects and that issues are identified and communicated to leaders.
- Drafts study reports with minimal supervision for assigned studies to include any annual reports, study close out reports as well as clinical sections for IDE, PMA, 510(k), and other regulatory submissions.
- Is responsible for critically assessing the literature and drafting Clinical Evaluation Reports (CERs) for new products.
- Supports clinical scientific discussions with regulatory agencies / notified bodies to drive support of the clinical and regulatory strategy, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization, line extensions, etc., including during sponsor regulatory inspections.
- Contributes to appropriate interpretation and dissemination of all evidence generated, including abstracts, manuscripts, CSRs, and use of clinical data/evidence for market access and reimbursement.
- Fosters strong relationships with key investigators to deliver evidence.
- Ensures registration on www.clinicaltrials.gov from study initiation through posting of results.
- Develops a strong understanding of the pipeline, product portfolio and business needs.
- Keeps management informed of key developments and issues that impact clinical strategy and portfolio management.
- May be involved in other tasks to support clinical research activities as needed.
- Generally, manages work with limited supervision. Senior staff member may review work during development, dependent on level of complexity, and upon completion.
- Is responsible for communicating business related issues or opportunities to next management level
- For those who supervise or manage a staff, is responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
- Is responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
- Performs other duties assigned as needed
SECTION 3: EXPERIENCE AND EDUCATION*A Bachelor's or equivalent degree in Biological Science or related discipline.
A minimum of 6 years related scientific / technical / clinical research experience.
SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS*
- Requires understanding of Good Clinical Practices
- Understanding and application of regulations and standards applied in clinical areas/regions is required
- Good presentation skills and effectively influencing of others
- Written and oral communication skills
- Demonstrated competencies in the following areas are required:
- Leadership in a professional and ethical manner
FUNCTIONAL AND TECHNICAL COMPETENCIES- Good understanding of clinical research science and processes along with an understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations.
- Ability to provide scientifically strategic and scientific clinical research input across NPD and LCM projects.
- Proven track record in delivering clinical projects within clinical / surgical research setting, on time, within budget and in compliance to SOPs and regulations.
- Ability to lead study teams to deliver critical milestones.
- Ability to collaborate across different functional areas within Clinical R&D to ensure alignment with governance processes (assigning roles and responsibilities, setting priorities, managing deliverables, etc.). and to meet business objectives.
- Demonstrated ability to build collaborative relationships with key internal and external partners and stakeholders.
- Leadership requirement - ability to influence, shape and lead without direct reporting authority;
• Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
• Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
• Performs other related duties as required.
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)).
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
