Director Clinical Research, Spine

le 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.

Job Summary: 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.

Duties & Responsibilities: This leader will be responsible for Clinical Research & Development activities for multiple complex projects across the Spine platform, including:
• 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.

Qualifications: 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: o Leadership in a professional and ethical manner o Technical writing skillsFunctional 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. Through transparent leadership, be a key leader in developing a high-performing team with a global culture. 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. Up to 20% travel domestic/international

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone Orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against based on disability.

Required Skills: Business Alignment, Clinical Data Management, Clinical Evaluations, Developing Others, Drug Discovery Development, Entrepreneurship, Good Clinical Practice (GCP), Inclusive Leadership, Industry Analysis, Leadership, Medicines and Device Development and Regulation, Regulatory Affairs Management, Relationship Building, Safety-Oriented, Scientific Research, Stakeholder Engagement, Strategic Change, Study Management

Preferred Skills: Business Alignment, Clinical Data Management, Clinical Evaluations, Developing Others, Drug Discovery Development, Entrepreneurship, Good Clinical Practice (GCP), Inclusive Leadership, Industry Analysis, Leadership, Medicines and Device Development and Regulation, Regulatory Affairs Management, Relationship Building, Safety-Oriented, Scientific Research, Stakeholder Engagement, Strategic Change, Study Management

The anticipated base pay range for this position is: $164,000.00 - $282,900.00

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 period 10 daysVolunteer 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: -