Ex-Vivo Clinical Specialist II (Silver Spring, Maryland) (Relocation Assistance Available)

The job details are as follows :

What We Do

We build on the strength of our research and development expertise and a distinctive, entrepreneurial culture that encourages diversity, innovation, creativity, sustainability, and, simply, fun.

Since inception, our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases.

Toward this goal we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, and we are working to create an unlimited supply of manufactured organs for transplantation.

We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC).

Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies;

and (b) technologies that expand the availability of transplantable organs. At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization.

Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her.

We are founder-led, and relentless in our pursuit of medicines for life . We continue to research and develop treatments for cardiovascular and pulmonary diseases, and other orphan diseases.

This is an on-site role in Silver Spring, Maryland . Relocation assistance will be provided as needed

How you’ll contribute

The Ex-Vivo Clinical Specialist II will develop the skills necessary to perform the clinical ex vivo lung procedure. This role will evaluate donor lung suitability, manage organ logistics, and coordinate the clinical team.

• Perform Referral Management Responsibilities, to include : Work with contracted call center to triage incoming EVLP referrals;
• Evaluate donor lung suitability from Organ Procurement Organization (OPO) or transplant center EVLP referrals; Review donor medical chart to confirm device inclusion and exclusion criteria;
• Initiate referral documentation in LBE’s data collection platform; At the request of the OPO, assist in identifying EVLP transplant centers;

and Assist OPO or transplant center with pre-EVLP logistics to ensure organs arrive within time frame required to execute EVLP procedure

• Perform EVLP Execution Responsibilities, to include : Coordinate clinical team arrival to LBE EVLP facility for surgical suite set-up;
• Prepare and set up EVLP systems and equipment according to established protocols; Create and control an aseptic zone; Evaluate physical lung condition and lead surgical cannulation / reconstruction of vessels and trachea;
• Operate and maintain the EVLP system and associated equipment; Manage all aspects of the EVLP procedure, including lung assessment, venous gas sampling, bronchoscopy, x-ray collection, recruitment, and deflation;
• Collect and conduct laboratory tests and analysis on preserved lungs to evaluate suitability for transplant; Maintain communication with LBE Medical Consultants and accepting transplant surgeon;
• Address and resolve medical / safety / eligibility questions from accepting transplant centers; Monitor adherence to protocols and determine EVLP case completion in conjunction with LBE Medical Consultant and accepting surgeon;
• Follow OPTN lung packaging procedures and prepare surgical area for next EVLP procedure; Assist the transplant center with post-EVLP logistics;
• Adhere to all safety protocols and procedures including proper handling and disposal of hazardous materials and surgical waste;

and Maintain all regulatory compliance frameworks associated with clinical procedures including, but not limited to FDA, UNOS, OPTN, CLIA, and CMS at the US federal and state level, as well as that of Health Canada

• Perform administrative responsibilities; to include : Participate in clinical review meetings and other administrative and scientific activities;
• Participate in quality control and quality assurance activities, including deviation documentation and SOP review; Collaborate and perform experiments with pre-clinical and translational medicinal colleagues in assessing the potential of new lung therapeutic development as needed;
• Attend staff meetings and provide input, as needed, into operational, clinical and regulatory development plans; Adhere to on call schedule as well as support regular daytime office hours;

and Work within all applicable Lung Bioengineering policies and procedures

Perform all other duties as required

For this role you will need

Minimum Requirements

• Associates Degree or commensurate experience and / or combination of education and experience
• 4+ years of experience as a Procurement Transplant Coordinator with critical care experience managing donor patients
• 1+ years of experience in sterile technique
• 1+ years of experience in direct participating in surgical procedures
• 2+ years of experience in critical care including ventilator management and blood gas interpretation
• Upon hire, ability to train onsite in Jacksonville, FL; Silver Spring, Maryland
• Upon initial training completion, successfully passing any qualification requirements
• Demonstrated specialized knowledge of lung physiology and mechanics
• Skilled with data collection and analysis
• Ability to operate Apple and PC; Microsoft Office Suite skills : Word, Excel, Outlook, PowerPoint required, as well as Adobe Acrobat, etc.
• Must be able to follow procedures and be competent in sterile technique and basic surgical skills, including suturing and tying

Preferred Qualifications

• Bachelor’s Degree or commensurate experience and / or combination of education and experience
• 2+ years of experience in advanced practice organ procurement / transplant
• CPTC - Certified Procurement Transplant Coordinator

At United Therapeutics, you’ll realize quickly that it is not an ordinary place to work! When you join our company, you will learn, grow, contribute, have fun, and be challenged.

all while making a difference in the lives of our patients.

While United Therapeutics does not require vaccination for Covid-19 at this time, we strongly encourage all employees and visitors to remain up to date on vaccinations and boosters to protect one another from illness.

Employees working in customer-facing roles must adhere and comply with customers’ credentialing guidelines, which may require vaccination against Covid -19, the influenza virus, and other illnesses that could be harmful to healthcare staff and patients.

United Therapeutics Corporation is an Equal Opportunity / Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities