Director, Clinical Research and Analytics

Position Description 

Carlsmed is seeking an experienced clinical scientist to lead the design and execution of clinical studies focused on spine surgery patients. This role will oversee multi-center clinical registries and retrospective patient studies to assess predicted versus actual surgical outcomes. Additionally, this position will collaborate with Medical Affairs to develop medical analyses and predictive models that enhance preoperative planning and postoperative assessments for internal quality processes. 

Key Responsibilities 

• Lead and contribute to post-market registry projects involving 15 U.S. study sites. 

• Design and execute clinical studies to address key research questions in spine surgery. 

• Develop and manage sponsored study protocols and supporting documentation, including study agreements, budgets, Case Report Forms (CRFs), site and sponsor guidelines, regulatory binders, and work instructions. 

• Prepare and submit Institutional Review Board (IRB) applications and manage ongoing communications. 

• Develop and apply predictive models for spinal alignment and clinical outcomes to optimize preoperative planning and postoperative evaluation. 

• Collaborate with Medical Affairs to analyze clinical outcomes and support internal quality improvement initiatives. 

• Conduct data analysis and predictive modeling for lumbar and cervical spine disorder treatments. 

• Author and publish clinical evidence through partnerships with internal teams (e.g., Medical Affairs, Marketing, Enabling Technologies), external surgeons, and third-party core laboratories. 

• Support regulatory authority audits for study sites and sponsors as needed. 

Skills 

• Excellent written communication skills, including reviewing and editing others’ work. 

• Study design, data analysis, and manuscript preparation. 

• Strong computer software skills (e.g., MS Word, Excel, Outlook, PowerPoint) 

• Effective communication and presentation skills. 

• Ability to manage subordinates while independently performing high quality work. 

• Continuous issue detection and resolution. 

Qualifications 

• Master’s degree in a biomedical field required; MD or PhD preferred. 

• 10 years of experience in clinical study design and execution, including familiarity with Good Clinical Practice (GCP), Good Documentation Practice (GDP), IRB processes, and FDA and international regulatory guidelines. 

• Experience supervising clinical research associates and data/analytics personnel. 

• Proficiency in statistical methods, data analysis software, and collaborations with consulting statisticians. 

• Strong track record of peer-reviewed publications in spine surgery and/or orthopedics. 

• Experience using and administering Electronic Data Capture (EDC) systems. 

• Ability to travel domestically up to five days per month. 

Equal Opportunity Employer 

Carlsmed is an equal-opportunity employer.  All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.  Carlsmed is committed to providing reasonable accommodation for candidates with disabilities in our recruitment process. If you need any assistance or accommodation due to a disability, please let us know. 

Compensation 

We are pleased to provide a competitive salary and benefits. Our benefits reflect our investment in the overall health and well-being of our employees and their families. including paying 100% of monthly healthcare, dental and vision insurance premiums, a 401(k) plan with employer matching, and unlimited PTO. Compensation may vary based on related skills, experience, and relevant key attributes.