LifeCell Corporation's portfolio of products includes our well-known soft-tissue repair products for abdominal wall reconstruction, breast reconstruction and breast plastic surgery. Our portfolio began with AlloDerm® Regenerative Tissue Matrix (RTM), which launched in 1994, and expanded with the launch of Strattice™ Reconstructive Tissue Matrix in 2008. In 2012, LifeCell further expanded its portfolio with the launch of AlloDerm® RTM Ready to Use.
In 2011, LifeCell introduced SPY Elite® System into the marketplace. The SPY Elite® system helps surgeons to intraoperatively assess tissue perfusion.
In June 2013, LifeCell introduced the REVOLVE™ System to offer fast and efficient fat transfer processing for use in a range of aesthetic and reconstructive procedures.
Position Summary: LifeCell is seeking a Job Title to work in a dynamic, innovative, entrepreneurial spirited environment where together we are transforming surgery. If you are self-motivated, enjoy a challenge and seek satisfaction knowing your efforts are making a difference in someone’s life, then this opportunity is for you.
Business critical role directing all global clinical development and execution of complex strategic clinical plans, in fully compliant fashion throughout LifeCell’s global regions to support regulatory requirements and obtain desired claims and indications.
Leads the Clinical Development & Operations function and works closely with other key internal stakeholders and external customers to assist in the strategic development of LifeCell’s global clinical plans and trial protocols, and ensure alignment with all regulatory and compliance requirements, and with strategic approved operating plans established by top management and executive leadership
Plan, at the earliest stages, coordinate, design, manage, implement and document clinical studies for Medical Devices and Tissue products, to ensure that appropriate and accurate clinical data on safety, efficacy, and/or health economics & reimbursement, are collected, stored, analyzed and delivered back to key internal and external customers to meet regulatory and business needs.
While directly managing North American clinical development and operations, this role will significantly support the EMEA Clinical Operations functions in a matrix structure. The EMEA Clinical Operations team will report both to EMEA Clinical and Scientific Affairs and in a dotted line to the Global Senior Director of Clinical Development and Operations. This team-based matix structure allows for local management (EMEA) of tactical operations while working very closely with the Global Director of Clinical Development and Operations to plan, approve and execute strategically aligned and fully compliant clinical studies.
Management and/or integration of Clinical Operations group across multiple disciplines and departments, including providing input into overall safety surveillance programs, to include post-marketing surveillance and post-market plans; supporting LifeCell regulatory filings by providing clinical data and/or describing clinical phenomena; providing input into multi-year publication plans.
Maintains a thorough knowledge of industry expectations and provides guidance and assistance to ensure that LifeCell sustains effective and efficient systems in support of global GCP compliant clinical studies and minimizes risks to the company by meeting regulatory standards.
Update management/internal customers/external customers as appropriate and necessary of clinical research projects, by providing business critical analysis and forecasting on clinical influences to the nature of the business and the market. Integrates clinical perspectives and outcomes data with strategic business measures to determine strategy around major corporate initiatives. Clarifies and resolves critical issues. Creates opportunities for growth and change through revisions to current industry practices. Develops and manages interpersonal relationships to influence decisions of senior leaders both within and outside of the company.
Manage departmental budget, to include annual forecasting and updating. Manage departmental personnel; identify, qualify and overseeing CROs and other vendors that may implement LifeCell sponsored clinical research projects.
Demonstrated experience in developing clinical strategy and study protocols. Coordination of Clinical studies for Class II and III Medical Devices (7 yr. Minimum in Medical Devices). Experience in working with IRB approval processes and contract negotiation. Demonstrated competence in compiling, writing and presenting protocols and final reports. Strong communication, presentation and influencing skills, leadership and ability to work cross functionally
Baccalaureate degree in health related science, preferably a health care professional
MS Degree in Nursing or Science is required
Our mission today is the same as it was when we began almost twenty years ago: to improve quality of life for those most in need of our help. It takes committed, caring people to achieve that vision—people with the expertise, creativity and dedication to bring new innovations to life. Maybe someone like you.
LifeCell is an Equal Employment Opportunity/Affirmative Action, Federal Contractor employer. All qualified applicants are encouraged to apply and will be considered without regard to race, sex, color, religion, national origin, age, genetic information, disability, protected veteran, or other legally protected status.
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