Associate Director, Clinical Research

About the role

Johnson & Johnson MedTech, Neurovascular, is recruiting an Associate Director, Clinical Research, to join our team. 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.

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Our Neurovascular team develops leading solutions for hemorrhagic and acute ischemic stroke. You will join a proud heritage of continually elevating standards of care for neurovascular stroke patients. Your unique talents will help patients on their journey to wellness.

Responsibilities

• Lead a team of clinical research professionals to manage clinical trials and deliver evidence generation/dissemination strategies (EGS/EDS) for multiple and/or complex projects within the JJMT Neurovascular Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.
• Responsible for the execution of Clinical R&D activities for multiple and/or complex projects.
• Manage a team of clinical research professionals to oversee clinical trials.
• Serve as the clinical team’s interface and collaborate with key opinion leaders, investigators, IRBs/ECs, regulatory agencies, contractors/vendors, societies, associations, and company personnel.
• Provide inputs on the development and execute the delivery of appropriate Global Evidence Generation Strategies (EGS)/Evidence Dissemination Strategies (EDS) to support New Product Development and Life-Cycle Management for transformational/complex programs.
• Foster collaborative relationships with all relevant Clinical R&D partners and cross-functional partners (e.g., Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics and Market Access, R&D, etc.), ensuring cross-functional alignment.
• Coordinate input and alignment from key regional MD Clinical R&D leads and other countries/regions in the development of the EGS/EDS.
• Lead study design to develop appropriate clinical trials to meet clinical evidence needs.
• Foster strong working relationships with external stakeholders.
• Partner with internal stakeholders to ensure accurate dissemination of clinical data/evidence in value briefs and technical summaries for market access and reimbursement.
• Responsible for delivery of assigned clinical programs through effective partnership with internal/external stakeholders to enable optimized engagement leading to delivery of clinical project commitments (on time, within budget, and in compliance with regulations and SOPs).
• Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders.
• Monitor assigned project budgets to ensure adherence to globally defined business plans.
• Lead clinical scientific discussions with regulatory agencies/notified bodies to drive support of the clinical and regulatory strategy, including the proposed clinical investigations and review process of clinical evidence generated for marketing authorization, line extensions, etc., including during sponsor regulatory inspections, in line with global frameworks.
• Serve as the clinical representative on a New Product Development team.
• Responsible for development of Post-Market Clinical Follow-up (PMCF) Plans and Reports, in line with global frameworks.
• Conduct review of promotional materials to ensure fair-balance, accuracy in clinical claims, and messaging.
• Manage and mentor resources assigned to designated clinical studies to provide quality deliverables while maintaining optimal efficiency.
• Provide performance feedback to direct reports (if applicable) as well as coaching and assistance in their development.
• Responsible for communicating business-related issues or opportunities to the next management level.
• Responsible for following all Company guidelines related to Health, Safety, and Environmental practices as applicable.
• For those who supervise or manage a staff, 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.
• Responsible for ensuring personal and Company compliance with all Federal, State, local, and Company regulations, policies, and procedures.
• Perform other duties assigned as needed.

Requirements

• Minimum of a Bachelor’s Degree, preferably in Life Science, Physical Science, Nursing, or Biological Science.
• A minimum of 8 years of related scientific/technical experience, including a leadership/management role within Clinical Research.
• Significant previous experience in clinical project leadership across multiple studies/programs.
• Experience working well with cross-functional teams.
• Experience with budget planning, tracking, and control.
• Relevant industry certifications preferred (e.g., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR).
• Clinical/medical background is a plus.
• A minimum of 1-2 years of people management-related experience is a plus.
• Medical device experience is highly preferred.

Skills

• 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 cross-functional teams to provide scientific clinical research input across New Product Development (NPD) and Life-Cycle Management (LCM) projects, including complex and/or transformational projects.
• Proven track record in delivering clinical programs within a clinical/surgical research setting, on time, within budget, and in compliance with SOPs and regulations.
• Strong presentation and technical writing skills.
• Strong written and oral English communication skills.
• Comprehensive understanding of clinical trial regulations across multiple regions.
• Ability to collaborate across different functional areas within Clinical R&D to ensure alignment with governance processes and to meet business objectives.
• Through transparent leadership, support shaping a high-performing team with a global culture.
• Ability to lead teams to deliver critical milestones, including complex projects.
• Advanced technical writing skills.
• Strong project management skills with the ability to handle multiple projects.
• Strong people management skills.
• Effective management of project budget processes.
• Ability to influence, shape, and lead without direct reporting authority.
• Change agent in team development and progression.

Leadership Competencies

• Connect: Foster strong partnerships with key internal and external stakeholders to ensure the development and timely delivery of innovative EGS/EDS.
• Shape: Build strong working relationships with external stakeholders and, through efficient use of resources, positively influence and shape the way clinical trial management is conducted and resources are utilized.
• Lead: Continue to develop expertise to provide inputs in the development of scientific clinical research strategies for complex programs, in line with global strategies. Through transparent leadership, ensure appropriate escalation of compliance issues.
• Deliver: Ensure clinical programs are delivered on time, within budget, and in compliance with SOPs and regulations. Ensure all sponsored studies have appropriately trained clinical trial leaders/specialists assigned.

Location & Travel

Primary location for this position is per management discretion. The position may be performed remotely. Ability to travel approximately 20-25% depending on the phase of the program.

Pay

The anticipated base pay range for this position is $137,000.00 - $235,750.00.

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.