Johnson & Johnson

Director, Clinical Research – Spine

Johnson & Johnson

full-time

Posted on:

Location Type: Hybrid

Location: Raynham • Florida • Massachusetts • United States

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Salary

💰 $164,000 - $282,900 per year

Job Level

Lead

About the role

  • Operating on behalf of DePuy Synthes, this leader will have deep scientific expertise to provide insights and strategic direction, developing evidence generation / dissemination strategies for transformational / complex programs for Spine.
  • Lead team of clinical research professionals to develop and deliver appropriate global evidence generation strategies to support New Product Development and Life-Cycle Management (NPD/LCM), building collaborative partnerships with leaders across functional groups that include Global Strategic Marketing, Medical Affairs, Regulatory Affairs, HEMA, R&D, etc.
  • Responsible for delivery of assigned clinical programs, through effective partnership with the Clinical Operations and Biostatistics & Data Management teams, to enable optimized engagement leading to delivery of clinical project commitments (delivery on time, within budget and in compliance with regulations and SOP).
  • Ensure input and strong alignment from key regional leads and other strategically important countries/regions in the development of the global evidence generation and dissemination strategies for the Spine platform.
  • Lead team of clinical research scientists to design appropriate clinical trials to meet the NPD / LCM needs.
  • Lead teams to ensure appropriate interpretation and dissemination of key evidence generated, including clinical study reports, post market clinical follow up (PMCF) and clinical evaluation reports, abstracts, manuscripts, etc.
  • Lead 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.
  • Responsible for team’s interface and collaboration with key opinion leaders, investigators, IRB’s/EC’s, Regulatory Agencies, societies, associations, etc.
  • Foster strong relationships with external stakeholders to shape and influence relevant policies, etc.
  • Partner with internal stakeholders to ensure accurate dissemination of clinical data/evidence in marketing collateral, value briefs and technical summaries for market access and reimbursement.

Requirements

  • Minimum of a Bachelor’s Degree in Biological Science or related discipline required.
  • A minimum of 8 to 10 years related scientific / technical experience, including leadership / management role within Clinical Research or with a PhD or Masters, these requirements would be a minimum of 6 years related scientific / technical experience.
  • A minimum of 2-3 years people management-related experience is required for this role.
  • Requires understanding of Good Clinical Practices.
  • Understanding and application of regulations and standards applied in clinical areas/regions is required.
  • Good presentation skills and effective influencing of others.
  • Excellent written and oral communication skills.
Benefits
  • 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 period 10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time-Off – 80 hours per calendar year
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
clinical researchevidence generationclinical trialsdata managementbiostatisticsregulatory strategyclinical evaluationmarket authorizationpost market clinical follow upNew Product Development
Soft Skills
leadershippeople managementcollaborationinfluencingpresentation skillscommunication skillsrelationship buildingstrategic directionteam managementstakeholder engagement
Certifications
Bachelor’s Degree in Biological SciencePhDMasters