Principal Scientist, Clinical Research

onal. 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 https://https://www.jnj.com

Job Function:
Discovery & Pre-Clinical/Clinical Development
Job Sub Function:
Clinical Development & Research - Non-MD
Job Category:
Scientific/Technology
All Job Posting Locations:
West Chester, Pennsylvania, United States of America, Zuchwil, Switzerland
Job Description:

We are searching for the best talent for a Principal Scientist, Clinical Research located in West Chester, PA.

Purpose: Operating on behalf of the Medical Device Group, this individual will have strong scientific expertise to provide insights and strategic direction to develop innovative evidence generation and dissemination strategies (EGS / EDS) for New Product Development and Life-Cycle Management (NPD and LCM) projects.

You will be responsible for:

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• Reports to the Franchise Platform Leader or Sn Clin Res Mgr., MD CR&D;

• Is responsible for Clinical R&D activities for assigned projects, including:

• Develops and deliver appropriate Global EGS / EDS to support NPD and LCM within the assigned platforms, with collaborative relationships with all relevant CR&D partners and cross-functional partners (e.g. Global Strategic Marketing, Medical Affairs, Regulatory Affairs, HEMA, R&D, etc.), ensuring cross- functional alignment;

• Is responsible for delivery of assigned clinical projects, through effective partnership with the Clinical Operations and BSDM teams, to enable optimized engagement leading to delivery of clinical project commitments (delivery on time, within budget and in compliance with regulations and SOP);

• Ensures input and strong alignment from key regional MD CR&D leads and other strategically important countries/regions in the development of the EGS / EDS.

• Leads in study design to develop appropriate clinical trials to meet the NPD / LCM needs.

• Leads in appropriate interpretation and dissemination of all evidence generated, based on EDS, including Clinical Study Reports, abstracts, manuscripts, CERs etc.

• Contributes in 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;

• Is responsible for team's interface and collaboration with key opinion leaders, investigators, IRB's/EC's, Regulatory Agencies, societies, associations, etc.

• Fosters strong relationships with external stakeholders to shape and influence relevant policies, etc.

• Partners with internal stakeholders to ensure accurate dissemination of clinical data/evidence in value briefs and technical summaries for market access and reimbursement

• 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.

FUNCTIONAL AND TECHNICAL COMPETENCIES

• Thorough understanding of clinical research science and processes along with a broad and extensive understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations.

• Ability to provide strategic and scientific clinical research input across NPD and LCM projects, including complex and / or transformational projects.

• Proven track record in delivering clinical programs within clinical / surgical research setting, on time, within budget and in compliance to SOPs and regulations.

• Comprehensive understanding of clinical trial regulations across multiple regions.

• Ability to lead teams to deliver critical milestones, including complex projects.

• Ability to collaborate across different functional areas within CR&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.

• Change agent in team development and progression.

• Experience in effective management of project budget processes

• 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.

Education:

• A Bachelor's degree in Biological Science or related discipline is required. An advanced degree is highly preferred.

• A minimum of 8 years related scientific / technical experience, including leadership / management role within Clinical Research.

Required Skills & Experience:

• 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

  • Technical writing skills

Other:

• This position is based in West Chester, PA, and requires up to 20% travel