Director of Clinical Affairs

SI-BONE is a fast-growing, publicly traded medical device company that is an industry pioneer in minimally invasive sacropelvic solutions. Our mission is to help patients rise up and reach for the stars, and our vision is to work together as the global leader to make sacropelvic conditions universally recognized and effectively treated through innovation, evidence, education, and advocacy.

Director of Clinical Affairs

Santa Clara, CA

Travel: Occasional

Salary range:

SI-BONE is focused on helping patients in one of the most under-served, under-diagnosed, and under-treated areas in orthopedics, the sacroiliac (SI) joint. SI-BONE developed an innovative, patented implant to fuse the SI joint. The iFuse Implant System provides a less invasive alternative to traditional sacroiliac (SI) joint fusion surgery and has been used in over 90,000 procedures to date.

We are a medical device company that is focused on improving the lives of patients with sacroiliac pelvic conditions. We are looking for people who are passionate about our mission and who are willing to work hard to achieve it. We are also looking for people who are:

• Agile: We work in a fast-paced environment and need to be able to learn and adapt to change quickly.
• Creative: We embrace creativity, and we need people who are not afraid to challenge the status quo.
• Team Players: We roll-up our sleeves and work together as one team to achieve our goals.
  
  

General Responsibilities:

The Director of Clinical Affairs reports directly to the Sr. VP of Clinical and Regulatory Affairs and is a key member of the clinical affairs team. This individual:

• Leads the planning, design and execution of all clinical affairs activities, including prospective and retrospective studies. Studies focus on SI-BONE devices but may involve adjacent technologies or therapeutic areas.
• Develops and implements clinical study strategies and operational processes to ensure successful planning, execution, and completion of clinical trials in alignment with company objectives.
• Ensures compliance to procedures and protocols in execution of clinical studies.
• Provides clinical leadership in cross-functional teams, partnering closely with R&D, Commercial and Regulatory to ensure evidence generation aligns with product development and business strategy
• Oversees and participates in analysis of clinical study data, ensuring data integrity and clinical relevance, guiding decisions based on insights and trends.
• Identifies and addresses complex clinical or medical issues through proactive evaluation of study data and collaboration with internal and external partners.
• Oversees monitoring and identification of trends in data capture or data quality to improve overall processes and drive continuous improvement.
• Identifies and assesses emerging device- or procedure-related adverse events trends as a result of clinical data collection and initiates timely actions to mitigate risk.
• Champions a culture of compliance, ensuring adherence to and promotion of the Company's Compliance Program, the AdvaMed Code of Ethics, the Company Code of Conduct, FDA regulations, privacy laws, federal anti-kickback statute, foreign corrupt practices act, anti-bribery and anti-corruption laws and all other applicable international, federal, state and/or local laws and regulations as it relates to execution of clinical studies.
• Sets an overall approach to clinical study execution that ensures high quality and efficiency.
  
  

This individual interacts with the following staff members at SI-BONE:

• Directs clinical research specialists and project managers within SI-BONE's clinical affairs department.
• Quality Affairs
• Regulatory Affairs
• R&D
• Marketing
• Reimbursement
• Finance and Legal
  
  

Specific Responsibilities:

• Executes and aids in the development of comprehensive clinical strategies, operational plans, resources, deliverables, budget and detailed timelines that will allow the achievement of the Company's clinical study goals
• Develops and writes effective US and OUS clinical study designs.
• Oversees all aspects of clinical operations, including obtaining internal approvals for clinical studies, IRB/EC approvals for studies, start-up activities such as approved investigator agreements, institutional contractual agreements, data collection and security, effective database management, data monitoring and analysis
• Aids in the writing of clinical trial reports for internal purposes, FDA, IRB, EC, Competent Authorities, as required, to support regulatory approval or product claims
• Manages the Clinical organization to ensure development of study documents, including informed consent forms, case report forms and instructions, site selection materials, investigator brochures and updates, and other project-specific documents required for the conduct of assigned studies
• Ensures clinical trial compliance with applicable regulations, guidelines and corporate policies.
• Develops, implements and maintains a robust project-specific tracking system to enable proper trial management and monitoring activities. Provide routine status reports and updates to the SVP, management team and employees.
• Supports the SI-BONE Quality System
• Other duties as assigned from time-to-time
  
  

Knowledge, Education and Experience:

• Master's degree or higher in science-related discipline
• Familiarity with statistical analysis of clinical studies
• Able to review data in Excel or other simple tools to screen for data issues
• Successful history of directing clinical studies in medical device companies manufacturing products used in the spine
  
  

Expertise and Attritbutes:

• Strong sense of urgency, discipline, commitment and organization skills with regard to clinical study execution
• Strong commitment to data quality and efficient processes
• Strong team player and team leader with excellent interpersonal skills
• Exceptional communicator with excellent written and verbal skills
• Ability to thrive in a challenging and fast paced environment and to proactively identify and resolve potential issues related to successful achievement of clinical goals
• Results-oriented, hands-on, entrepreneurial and self-motivated
• Accomplished and pragmatic decision-maker
• Creative, flexible problem solver who is able to think "outside the box"
• Demonstrated positive "can do" attitude
• Highly intelligent with effective analytical and problem-solving skills
• Proactive person who attacks problems, displaying initiative and perseverance to bring about meaningful change; and open and responsive to new ideas
• High integrity, sound character, a tremendous work ethic and the passion to succeed
• Knowledge and familiarity of applicable regulations/standards (e.g. ISO 14155, 13485, 14971, FDA 21 CFR 820, EU MDR 2017/745) as required to perform the job function
  
  

Salary range: . The compensation range for this position is specific to the location and is in good faith what SI-BONE expects to pay for the position taking into account the wide variety of factors that are considered in making compensation decisions, including job-related knowledge; skillset; experience, education and training; certifications; and other relevant business and organizational factors.

Supplemental pay: bonus and stock

There are potential risks associated with the iFuse Implant System. It may not be appropriate for all patients and all patients may not benefit. For additional information on the company or the products including risks and benefits, please visit www.si-bone.com/risks.

We are aware of active recruitment scams using the SI-BONE name, in which individuals pose as our recruiters and post fake remote job openings and make fake job offers on the Internet. Please note, we will never make an offer of employment without conducting multiple rounds of interviews face-to-face using secure video-conferencing technology. We will never ask candidates to cash checks or make a payment in order to be considered for a position. SI-BONE only uses company email addresses, which contain "@si-bone.com" to communicate with candidates.

If you believe you've been a victim of a phishing scam, please visit the Cybersecurity & Infrastructure Security Agency at https://www.cisa.gov/be-cyber-smart/report-incident learn how to report it.