Staff Scientist, Clinical Development & Research

Johnson & Johnson Innovative Medicine • Warsaw, IN

2d • $109,000 - $174,800 • Hybrid

About The Position

This role is within the Orthopaedics division of Johnson & Johnson, which is developing next-generation treatments at the intersection of biology and technology. The company is in the process of separating its Orthopaedics business to form a standalone company, DePuy Synthes. If hired, the employee would transition to DePuy Synthes employment. The Staff Scientist, Clinical Development & Research will be responsible for developing clinical evidence generation (EGS) and evidence dissemination (EDS) strategies for New Product Development (NPD) and Life-Cycle Management (LCM) projects. This is a field-based role available in the United States, with potential for remote work on a case-by-case basis. The role requires a strong understanding of clinical research science, processes, and global regulations, with a proven track record in delivering clinical projects on time, within budget, and in compliance with regulations.

Requirements

• A Bachelor’s or equivalent degree in Biological Science or related discipline.
• A minimum of 6 years related scientific / technical / clinical research experience.
• Understanding of Good Clinical Practices.
• Understanding and application of regulations and standards applied in clinical areas/regions.
• Good presentation skills and ability to influence others.
• Written and oral communication skills.
• Leadership in a professional and ethical manner.
• Technical writing skills.
• Good understanding of clinical research science and processes.
• 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 a clinical / surgical research setting, on time, within budget, and in compliance with 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 and meet business objectives.
• Demonstrated ability to build collaborative relationships with key internal and external partners and stakeholders.
• Leadership 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 compliance program-related activities.

Nice To Haves

• Background or experience in Biomaterials and/or Spine.

Responsibilities

• Contributes to the development and delivery of appropriate Global EGS / EDS to support NPD and LCM within assigned platforms, collaborating with Clinical R&D, R&D, Global Strategic Marketing, Medical Affairs, Regulatory Affairs, and 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 EGS / EDS.
• Develops and drafts clinical trial protocols, informed consents, investigator brochures, and other study materials.
• Plans for study budgets and collaborates with Clinical Operations to manage the development of Investigator agreements, site contracts, vendor agreements, payments, and financial disclosures.
• Responsible for the delivery of assigned clinical programs through partnership with Clinical Operations and Biostatistics and Data Management teams, ensuring delivery on time, within budget, and in compliance with regulations and SOPs.
• Develops collaborative relationships with the study core team to ensure study progress and timely issue identification and communication.
• Drafts study reports, including annual reports, study close-out reports, and clinical sections for regulatory submissions (IDE, PMA, 510(k)).
• Responsible for critically assessing literature and drafting Clinical Evaluation Reports (CERs) for new products.
• Supports clinical scientific discussions with regulatory agencies/notified bodies regarding clinical and regulatory strategy, review of clinical evidence for marketing authorization, and sponsor regulatory inspections.
• Contributes to the interpretation and dissemination of evidence, including abstracts, manuscripts, CSRs, and the use of clinical data 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 impacting clinical strategy and portfolio management.
• May be involved in other tasks to support clinical research activities as needed.
• Manages work with limited supervision; senior staff may review work.
• Responsible for communicating business-related issues or opportunities to the next management level.
• Responsible for ensuring personal and Company compliance with all applicable regulations, policies, and procedures.
• Performs other duties assigned as needed.

Benefits

• Vacation – 120 hours per calendar year
• Sick time - 40 hours per calendar year (varies by state)
• 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 period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Senior