Clinical Research Director Jobs

About The Position

Requirements

• Bachelor’s degree in Life Sciences, Health Sciences, Engineering, or a related discipline.
• At least 8 years of progressive clinical research or clinical operations experience, including a leadership or management role within Clinical Research.
• At least 2 years of people-management experience.
• 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 applicable to clinical areas and regions.
• 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.
• English proficiency.

Nice To Haves

• A Master’s or PhD in a scientific or clinical discipline.
• 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 use of real-world evidence datasets to support medical device regulatory submissions, reimbursement and market access needs, and surgeon adoption.
• Clinical research or project management certifications, such as ACRP, SOCRA, or PMP.

Responsibilities

• Lead a team of clinical research professionals in developing and delivering 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 to deliver clinical programs on time, within budget, and in compliance with regulations and internal procedures; oversee study milestones, enrollment projections, risks, and deliverable quality.
• Work with regional clinical leaders and cross-functional stakeholders to identify evidence gaps and align global evidence priorities and plans with clinical practice, customer, regulatory, and reimbursement needs.
• Lead clinical research scientists in designing studies to address prioritized evidence gaps and product development and life-cycle management needs; partner with Clinical Operations on feasibility, site selection, start-up, execution, and close-out.
• Lead interpretation and dissemination of clinical evidence through clinical study reports, Post Market Clinical Follow Up plans and reports, abstracts, and manuscripts.
• Partner with internal stakeholders to ensure evidence is accurately used in value briefs and technical summaries supporting market access and reimbursement.
• Lead clinical scientific discussions with regulatory agencies and notified bodies in support of global clinical and regulatory strategies, proposed 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.
• Develop collaborations with national and international joint replacement and medical device registries to support data requests, analyses, research partnerships, and real-world evidence interpretation.
• Ensure clinical programs comply with Good Clinical Practice, country regulatory and ethics requirements, and internal quality procedures, including oversight of informed consent, safety reporting, essential documentation, and data integrity.
• Provide 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 and ensure team members follow the guidelines and have necessary resources.
• Ensure personal and Company compliance with applicable Federal, State, and local regulations and Company policies and procedures.
• Perform other duties as assigned.

Benefits

• Participation in the Company’s consolidated retirement plan (pension) and savings plan (401(k)), subject to plan terms.
• Eligibility for the Company’s long-term incentive program.
• Vacation: 120 hours per calendar year.
• Sick time: 40 hours per calendar year, with different state-specific amounts for Colorado and Washington residents.
• 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 a child’s birth, adoption, or foster care placement.
• Bereavement Leave: up to 240 hours for an immediate family member and 40 hours for an extended family member per calendar year.
• Caregiver Leave: 80 hours in a 52-week rolling period.
• Volunteer Leave: 32 hours per calendar year.
• Military Spouse Time-Off: 80 hours per calendar year.