Associate Director, Clinical Research- Knee

Education

• Bachelor’s degree in Life Sciences, Health Sciences, Engineering, or a related discipline (required)

• Advanced degree (Master’s or PhD) in a scientific or clinical discipline (preferred)

• Minimum of 8 years of progressive clinical research or clinical operations experience, including leadership / management role within Clinical Research.

• A minimum of 2 years people management experience is required for this role

• Demonstrated experience managing medical device clinical studies across multiple phases of execution

• Understanding and application of Good Clinical Practices

• Understanding and application of regulations and standards applied in clinical areas/regions is required

• Demonstrated professional and ethical leadership in a matrixed organization

• Experience supporting global regulatory submissions, post-market clinical follow-up, investigator-initiated research, or externally sponsored research for medical devices.

• Clinical research experience in orthopedics, joint replacement, trauma, spine, sports medicine, or other implantable or surgical medical devices.

• Experience using registry or real-world data to identify evidence gaps, support post-market surveillance, evaluate device performance, or inform clinical, regulatory, reimbursement, or market access strategies.

• Knowledge of global medical device research environments, including local ethics, governance, regulatory, site, and investigator requirements.

• Demonstrated utilization of real-world evidence datasets to deliver evidence that supports medical device regulatory submissions, reimbursement and market access needs, and drive surgeon adoption

• Language: English proficiency required.

• Travel: Up to 20% domestic and international

• Certifications: Clinical research or project management certifications (e.g., ACRP, SOCRA, PMP) preferred.

• Lead a team of clinical research professionals to develop and deliver global evidence-generation and evidence-dissemination strategies for the Knee Reconstruction platform, supporting new product development and life-cycle management.

• Partner with Clinical Operations and Biostatistics and Data Management teams to deliver assigned clinical programs on time, within budget, and in compliance with applicable regulations and internal procedures; oversee study milestones, enrollment projections, risks, and the quality of deliverables.

• Partner with regional clinical leaders and Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Market Access, R&D, and other cross-functional stakeholders to identify evidence gaps and integrate clinical practice, customer, regulatory, and reimbursement needs into aligned global evidence priorities and plans.

• Lead clinical research scientists in designing clinical studies to address prioritized evidence gaps and new product development and life-cycle management needs; partner with Clinical Operations on feasibility, site selection, study start-up, execution, and close-out.

• Lead the interpretation and dissemination of clinical evidence through clinical study reports, Post Market Clinical Follow Up plans & reports, abstracts, and manuscripts; partner with internal stakeholders to ensure accurate use of evidence in value briefs and technical summaries supporting market access and reimbursement.

• Lead clinical scientific discussions with regulatory agencies and notified bodies to support global clinical and regulatory strategies, proposed clinical investigations, marketing authorizations, and line extensions; provide clinical scientific support during regulatory inspections.

• Build and maintain relationships with key opinion leaders, orthopedic investigators, clinical sites, research networks, ethics committees, professional societies, and associations to advance clinical research collaborations and inform relevant evidence policies.

• Develop collaborations with national and international joint replacement and medical device registries to support data requests, analyses, research partnerships, and interpretation of real-world evidence that informs global evidence strategies.

• Ensure clinical programs comply with Good Clinical Practice, relevant country regulatory and ethics requirements, and internal quality procedures, with oversight of informed consent, safety reporting, essential documentation, and data integrity.

• Provide clear program status reporting, evidence-based decision support, and coordination across regions and time zones; escalate business issues, opportunities, and risks to the appropriate management level.

• Support audit and inspection readiness through complete study documentation, coordinated responses, interview preparation, and timely completion of corrective and preventive actions for study-related findings.

• Follow applicable Company Health, Safety and Environmental guidelines; ensure team members follow these guidelines and have the resources needed to do so.

• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

• Performs other duties assigned as needed