Company Profile:

Founded in 1996 and headquartered in San Luis Obispo, CA, FzioMed, Inc. is a vertically integrated medical device company, that develops, manufactures and commercializes absorbable surgical biomaterials used by surgeons to improve surgical healing.  A 2023 Best Places to Work – SoCal winner, FzioMed is the recognized global leader in providing absorbable adhesion barriers, based on its patented dual-polymer technology and markets and distributes its products in more than 70 countries. 

Job Summary:

Reporting to the Vice President of Operations, the Clinical Affairs Manager will be responsible for planning, executing and managing initiatives and activities associated with the company’s global clinical trials, including developing, overseeing, monitoring US randomized clinical trials and OUS post-marketing studies, as well as supporting pre-clinical studies and providing key input to support the company in its upstream and business expansion projects and processes. 

Duties / Responsibilities:

Oversee clinical operations and data collection function; develop infrastructure to support clinical trials;

Lead team participation in planning for and supporting submissions and interactions with the FDA;

Establish and approve methods for design and implementation of clinical protocols, data collection systems and final reports;

Plan, write and execute clinical studies in conjunction with the Marketing and Research & Development departments, as well as medical experts;

Oversee conversion rate optimization and/or clinical data processing, including form design, data tracking, data entry codes and document processing; plan and review data analysis and determine final presentation of results;

In conjunction with Regulatory Affairs department, support timely submission of IDE Annual Reports with all divisions of Center for Devices & Radiological Health;

Review and analyze new and evolving International Conference on Harmonization (ICH) guidelines, European Union regulations and assist appropriate areas of company to support the quality management systems;

Act as the primary contact for interaction with FDA and other regulatory agencies, relative to agency inspections, compliance documentation and information related to clinical trial activity;

Lead team participation in providing direction, coordination and evaluation of outside clinical consultants. 

Qualifications:

Bachelor’s Degree in Biotechnology, Pharmaceuticals, Medical Device Engineering, or similar discipline;

At least 5 years of successful related experience in a similar managerial capacity;

In-depth experience with Contract Research Organizations (CROs), developing clinical study protocols and managing randomized clinical trials;

Thorough understanding of clinical development, clinical research and related regulatory requirements, particularly Good Clinical Practice guidelines;

Proficiency with the Microsoft Office suite of products and industry-related software applications;

Exemplary oral and written communication and interpersonal skills;

Astute time management, organizational, attention to detail, accuracy, multi-tasking, problem-solving and follow-through skills;

Ability to understand company needs, build strong alliances/networks internally and externally, utilize innovative approaches to improve processes and provide inspirational leadership;

Ability to work effective and efficiently alone and within a team environment;

Ability to travel. 

Working Hours:

8:00AM – 5:00PM Monday - Friday 

Compensation:

$110,000 - $140,000 annual base salary DOE, for this full-time, exempt position. 

Benefits:

Paid time off (vacation/sick time) of 17 days annually;

1 week paid time off between Christmas and New Year;

9 paid public holidays annually, plus 1 floating holiday;

401(k) with annual company match;

Medical, dental, vision subsidized 100% for the employee and partially subsidized for employee’s dependents;

Cafeteria 125 Plan. 

Location:

San Luis Obispo, CA.  This is a complete in-office role and not a remote/hybrid work possibility.

Relocation assistance possible.