United Therapeutics Manager, Investigator Contracts in Durham, North Carolina
The Job Details are as follows:
What we do
United Therapeutics is a biotechnology company that focuses on the development and commercialization of unique products to address the unmet medical needs of patients with chronic and life-threatening conditions.
We currently have five approved products on the market and a long-term mission of providing an unlimited supply of transplantable organs for those who need them.
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, pediatric cancers and other orphan diseases.
How you’ll contribute
Provide oversight to the clinical trial agreement (CTA) team and process; ensure procedures, compliance, documentation and data captured across the team is consistent and allows for detailed metrics to be distributed to internal stakeholders.
Provide leadership to Investigator Contracts team
Oversee Clinical Contracts Specialists, providing both technical and strategic guidance
Review and provide input into overall CTA process, including budget development, CTA review, and compliance process. Oversee maintenance for processes across all studies
Analyze agreements, providing data and metrics review to evaluate current agreements for:
Validity and expiration tracking of NDAs
Rates across sites
Rates across studies
Rates across company (Lung, EVLP, UTC - where are there gaps?)
Provide technical expertise in CTA process and negotiation
Interact with internal stakeholders including legal, compliance, finance, clinical, and medical affairs in relation to CTA processes; and with institutions and PIs regarding contract and budget negotiation
Perform other duties as assigned
For this role you will need
BA/BS degree; business-related field preferred
8+ years of clinical trial agreement (CTA) experience in the pharmaceutical/CRO industry, with 5+ years of experience leading and managing direct reports
Demonstrated strength in leading, overseeing, and providing guidance to a team
Technical expertise with institutional agreements and clinical site negotiations
Strong analytical skills with ability to review and evaluate metrics across clinical sites and across clinical studies to suggest improvements and efficiencies for procedures and negotiations
Ability to multitask, managing and prioritizing multiple projects/data at once
Excellent communication skills with internal and external stakeholders
Strong organization and attention to detail
Proficiency with MS Office, specifically with MS Excel (must have experience writing formulas and with pivot tables, etc.)
Ability to travel up to 10% as needed
Clinical Project Management or related clinical management experience preferred
Experience with GrantPlan/Compliance FMV Tool
Life as a Unitherian
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.
We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success.
We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level of job performance and provides state of the art facilities to flourish. This is what makes United Therapeutics a stimulating place to work.
United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities
United Therapeutics currently has five approved products on the market, and a long-term mission of providing an unlimited supply of transplantable organs for those who need them! Our employees can be found collaborating across the United States, Europe and Asia.
We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high level job performance, and provide state of the art facilities in which to flourish. This is what makes United Therapeutics a stimulating place to work. We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation, and achievement into success.