Director Clinical Research, Spine

Johnson & Johnson Innovative Medicine•Warsaw, IN

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. 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 jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. 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. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Orthopaedics? Ready to join a team that’s reimagining how we heal? Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

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
Demonstrated competencies in the following areas are required:
Leadership in a professional and ethical manner
Technical writing skills Functional and technical competencies
Deep expertise in 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 lead a team of scientists to provide strategic and scientific clinical research input across new product development and legacy projects.
Proven track record in delivering clinical programs within clinical / surgical research setting, on time, within budget and in compliance to procedures and regulations.
Comprehensive understanding of clinical trial regulations across multiple regions.
Ability to lead teams to deliver critical milestones.
Ability to collaborate across different functional areas within Clinical Research execution 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 progression.
Experience in effective management of project budget processes.

Responsibilities

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.
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.

Benefits

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.
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