U

United Therapeutics Corporation

Biotech company develops PAH therapies

Clinical Project Manager 2 / Senior Clinical Project Manager

Full-TimeUpdated on 10/23/2026
No salary listed
Senior, Expert
Bachelor's, Master's
Durham, NC, USA
HybridHybrid schedule: 4 days per week in office and 1 day from home; travel up to 30%. In-office requirements may change based on business needs.
Biology & BiotechClinical Research Operations

About the job

Requirements
  • A bachelor's degree in a related field and at least 8 years of related clinical study management or project management experience in CRO/pharmaceutical operations and development for the Clinical Project Manager II level.
  • A master's degree in a related field and at least 6 years of related clinical study management or project management experience in CRO/pharmaceutical operations and development for the Clinical Project Manager II level.
  • A bachelor's degree in a related field and at least 10 years of related clinical study management or project management experience in CRO/pharmaceutical operations and development for the Senior Clinical Project Manager level.
  • A master's degree in a related field and at least 8 years of related clinical study management or project management experience in CRO/pharmaceutical operations and development for the Senior Clinical Project Manager level.
  • Ability to interact and communicate effectively, verbally and in writing, with colleagues, upper management, Key Opinion Leaders, vendor personnel, clinical investigators, and site personnel, both within and outside clinical operations.
  • Strong working knowledge of Good Clinical Practice and International Council for Harmonisation regulations and guidelines.
  • A strong overall scientific and clinical/medical research background.
  • Experience working independently and as part of a cross-functional team.
  • Proficiency with Microsoft Office Suite, including Word, Excel, PowerPoint, and Outlook.
  • Experience with electronic data capture and clinical trial management systems.
  • Commitment and ability to handle high workloads, demanding situations, and deadlines.
  • Ability to proactively identify potential issues and formulate potential courses of action.
Responsibilities
  • Work independently to ensure the success of a local or regional clinical trial.
  • Provide oversight and coordination for operational delivery of ongoing local or regional clinical trials, ensuring required timelines are met and budget, quality, and performance expectations are followed.
  • Serve as the primary study contact for study-related communication, using advanced expertise and coordinating with teams, management, and vendors.
  • Oversee the entire lifecycle of clinical trials, from start-up to close-out.
  • Direct local or regional clinical trials, ensuring cross-functional activities align with study objectives.
  • Administer study budgets and timelines while maintaining quality standards and performance metrics.
  • Identify, resolve, or promptly escalate concerns regarding study timelines and deliverables.
  • Proactively escalate performance-related concerns with appropriate line management.
  • Manage protocol deviations and violations, reducing their occurrence through proactive collaboration.
  • Collaborate with Clinical Operations to monitor key performance indicators and enhance study efficiency.
  • Provide consistent study progress updates to the project team and management.
  • Manage insourcing and outsourcing partners, ensuring compliance with standards and expectations.
  • Contribute to developing study concepts, protocols, and critical study documents.
  • Contribute to developing policies, guidelines, and standard operating procedures for Clinical Operations and Study Management.
  • Assess current processes and recommend improvements to management.
  • Ensure study conduct aligns with standard operating procedures, International Council for Harmonisation/Good Clinical Practice guidelines, and local regulations.
  • Manage vendor relationships, including selection, negotiation, implementation, and statement of work oversight.
  • Ensure comprehensive protocol and process training for study team members.
  • Manage resources allocated to the study, excluding staff management.
  • Review and endorse team member transition plans as necessary.
  • Assist in preparing interim and primary analysis reports.
  • Organize and oversee Investigator Meetings.
Desired Qualifications
  • A master's degree.
  • At least 3 years of related experience as a clinical research associate, Clinical Manager, and/or Project Manager in the biopharmaceutical industry.
  • Registered Nurse state licensure and/or compact state licensure.
  • Previous experience with all phases of clinical research.
  • Demonstrated leadership experience, including motivating teams, providing advanced planning analysis, and providing strategic guidance by evaluating risks against departmental deliverables.

About the company

U

United Therapeutics Corporation

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Website

United Therapeutics develops therapies for life-threatening diseases, with a focus on pulmonary arterial hypertension and rare conditions. Its approved medicines, including Remodulin, Tyvaso, Orenitram, Adcirca, and Unituxin, treat PAH and pediatric neuroblastoma and are delivered by injections, inhalations, or oral tablets. The company also pursues regenerative medicine and xenotransplantation through its Lung Biotechnology PBC and Revivicor units to create bioengineered organs for transplant. It differentiates itself by combining drug development with organ engineering and by operating as a Public Benefit Corporation that balances profits with social and environmental goals, aiming to extend lives and increase access to transplantable organs.

Company Size

N/A

Company Stage

IPO

Headquarters

Silver Spring, Maryland

Founded

1996

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Simplify's Take

What believers are saying

  • FDA accepted ralinepag NDA August 2026 and nebulized Tyvaso sNDA September 2026.
  • Q2 2026 net income rose to $333 million; buybacks retired 5.84% shares.
  • Phase 3 ADVANCE OUTCOMES and TETON showed improvement across PAH and IPF programs.

What critics are saying

  • Q2 2026 revenue fell 2%; Tyvaso sales dropped, exposing heavy product concentration.
  • Liquidia’s appeals and labeling fights can still blunt Treprostinil economics by 2027.
  • If ralinepag and IPF filings disappoint FDA, United Therapeutics remains a single-portfolio biotech.

What makes United Therapeutics Corporation unique

  • Martine Rothblatt built United Therapeutics around PAH drugs plus xenotransplantation, with three operating organ sites.
  • September 2026 Delaware ruling strengthened its treprostinil patent moat against Liquidia’s Yutrepia.
  • Stewartville’s August 12, 2026 DPF facility expands gene-edited pig organ production capacity.

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Benefits

  • Health Insurance
  • Dental Insurance
  • Vision Insurance
  • Life Insurance
  • Disability Insurance
  • Health Savings Account/Flexible Spending Account
  • 401(k) Retirement Plan
  • 401(k) Company Match
  • Paid Time Off
  • Paid Holidays
  • Paid Vacation
  • Parental Leave

Company News

Associated Press
Oct 20th, 2026
United Therapeutics opens third pathogen-free xenograft facility in Houston to scale organ production

United Therapeutics has opened its third Designated Pathogen-Free (DPF) facility, in Houston, Texas. The site produces xenografts, which are animal organs for transplant into humans. The first facility opened in Christiansburg, Virginia, in 2024 to supply clinical trials. The second opened in Stewartville, Minnesota, on August 12, 2026. The Houston and Stewartville sites are built to scale commercial production if regulators approve the products. The facilities use air and water filtration, filtered feed, and decontamination entryways to keep out pathogens. Solar arrays offset a significant part of their energy use. "Every day, people with end-stage organ disease die waiting for an organ that never comes," said chief executive officer Martine Rothblatt. The products remain investigational and are not approved anywhere.

MarketScreener
Oct 20th, 2026
United Therapeutics expands organ manufacturing capabilities with opening of third Designated Pathogen-Free Xenograft Production Facility.

United Therapeutics expands organ manufacturing capabilities with opening of third Designated Pathogen-Free Xenograft Production Facility. Named for Dr. Bartley P. Griffith and Dr. Robert A. Montgomery, pioneers in xenotransplantation, the biosecure facility is purpose-built to manufacture United Therapeutics' xenokidneys and xenohearts for its rapidly advancing xeno-organ manufacturing program Published on 10/20/2026 at 07:03 am EDT Business Wire United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced the opening of its third Designated Pathogen-Free (DPF) facility, The Dr. Bartley P. Griffith and Dr. Robert A. Montgomery Xenograft Production Facility, in Houston, Texas. United Therapeutics opened its first DPF facility in Christiansburg, Va. in 2024 to produce xenografts for ongoing clinical trials. The company celebrated the opening of its second facility, The Thomas E. Starzl Xenograft Production Facility, in Stewartville, Minn. on August 12, 2026. The two new facilities in Stewartville and Houston are designed to enable United Therapeutics to scale commercial production of its xeno-organs following approval of these products. All three facilities are crucial for advancing the company's organ manufacturing program. These facilities are a feat of biotechnology engineering, requiring a strictly controlled, biosecure barrier environment, including air filtration, filtered water, filtered feed supplies, and state-of-the-art decontamination entryways. They include hundreds of miles of carefully calibrated air and water conduits to support the transplantability of the final xenograft products and to help prevent contamination from pathogens. United Therapeutics also installed solar arrays on the remaining land for all three facilities, allowing them to offset a significant portion of their energy use with solar power. "Every day, people with end-stage organ disease die waiting for an organ that never comes. With our third xenograft production facility now open and clinical trials underway, United Therapeutics is moving closer to its goal of providing transplantable organs to the people who need them. It is fitting that this facility is named for Dr. Griffith and Dr. Montgomery, whose first-in-human surgeries turned xenotransplantation from a theoretical possibility into a clinical reality," said Martine Rothblatt, Ph.D., Chairperson and Chief Executive Officer of United Therapeutics. Bartley P. Griffith, MD, FACS, FRCS revolutionized medicine by pioneering artificial hearts that have now been implanted over 15,000 times. He made history by successfully conducting the world's first transplants of United Therapeutics' xenohearts in 2022 and 2023. Dr. Griffith's creation of a nationwide network of expert organ procurement surgeons has supported United Therapeutics' Lung Bioengineering program, which uses ex vivo lung perfusion technology to enable transplant surgeons to evaluate marginal donor lungs that frequently go untransplanted, and it has led to hundreds of lung transplants. Robert A. Montgomery, MD, DPhil, FACS is known for many transformative innovations in transplantation that have enabled thousands of successful transplants. His research efforts led to "kidney exchanges" and passage of the Norwood Act, which allows living kidney donors who are biologically incompatible with their own intended recipients to swap with another incompatible pair. Dr. Montgomery's work drastically improved treatment for antibody-mediated organ rejection, a significant obstacle to successful xenotransplantation. In 2025, Dr. Montgomery successfully transplanted the first xenokidney into a patient with end-stage renal disease (ESRD) in United Therapeutics' EXPAND clinical trial, a watershed moment for United Therapeutics' vision to broaden access to transplantable organs. About United Therapeutics Xenotransplantation Program United Therapeutics is advancing clinical trials intended to support a Biologics License Application with the U.S. Food and Drug Administration for each of its three investigational xenotransplantation products, UKidney(TM), UThymoKidney(TM), and UHeart(TM): * EXPAND (NCT06878560) is a multicenter, open-label, safety and efficacy study of UKidney in patients with ESRD; * EXTEND (NCT07224763) is a multicenter, open-label, safety and efficacy study of UThymoKidney in patients with ESRD; and * EXPRESS is an open-label, safety and efficacy study of UHeart in patients with advanced heart failure. It will start at a single center with potential to include other centers if the initial data are supportive. The UKidney and UHeart are derived from a pig with 10 gene edits. Six human genes are added to the pig genome to facilitate immunological acceptance and compatibility of the organ in the human recipient. Four porcine genes are inactivated or "knocked out" to reduce the risk of organ rejection and to moderate organ growth. The UThymoKidney is derived from a pig with a single gene edit together with tissue from the pig's thymus. The pig's thymus tissue is intended to condition the recipient's immune system to recognize the UThymoKidney as "self" and reduce the likelihood of rejection. Alternative organ sources are needed, as demand for organ transplants far exceeds the supply of available organs. If clinical trials are successful, the UKidney, UThymoKidney, and UHeart have the potential to mitigate the world's organ shortage crisis. United Therapeutics' xeno-organs are all investigational-stage products which have not been approved in any jurisdiction for any indication. About United Therapeutics Founded by CEO Martine Rothblatt to discover a cure for her daughter's life-threatening rare disease, pulmonary arterial hypertension, United Therapeutics transforms the treatment of rare diseases and pioneers alternatives to expand the supply of transplantable organs. From our innovative therapies to our groundbreaking manufactured organs, we are bold and unconventional. We move quickly from scientific theory to practical technologies that can save lives. As a public benefit corporation, even our legal structure reflects our commitments. We serve patients, act with integrity, create long-term shareholder value, and operate with sustainable practices that protect the future we are working to build. Visit us at www.unither.com and follow us on LinkedIn, Facebook, and Instagram. Forward-Looking Statements Statements included in this press release that are not historical in nature are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, among others, statements regarding: our plans to develop and obtain FDA approval for our xeno-organ products; the potential for our UKidney, UThymoKidney, and UHeart products to mitigate the world's organ shortage crisis; the potential for our DPF facilities to enable us to scale the manufacturing of our xeno-products following regulatory approvals; and our goals of expanding the supply of transplantable organs, developing practical technologies that can save lives, creating long-term shareholder value, and operating with sustainable practices. These forward-looking statements are subject to certain risks and uncertainties, such as those described in our periodic reports filed with the Securities and Exchange Commission, that could cause actual results to differ materially from anticipated results. Consequently, such forward-looking statements are qualified by the cautionary statements, cautionary language, and risk factors set forth in our periodic reports and documents filed with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. We claim the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We are providing this information as of October 20, 2026, and assume no obligation to update or revise the information contained in this press release whether as a result of new information, future events or any other reason. UKIDNEY, UTHYMOKIDNEY, and UHEART are trademarks of United Therapeutics Corporation. View source version on businesswire.com: https://www.businesswire.com/news/home/20261020627473/en/ (C) Business Wire - 2026

The Business Journals
Oct 20th, 2026
United Therapeutics opens xeno-organ facility in Generation Park, marking Houston's continued pharma growth.

United Therapeutics opens xeno-organ facility in Generation Park, marking Houston's continued pharma growth. Oct 20, 2026 Preview this article 1 min United Therapeutics has been working toward a Houston presence for over a year, and its newly opened facility will soon call pharma giants Eli Lilly and Bristol Myers Squibb its neighbors. Don't Stop Here - Continue Reading For $1 Per Week Secure 4 weeks of award-winning news and trusted insights Subscribe for only $4

Yahoo Finance
Oct 16th, 2026
Two cash-rich stocks to watch, United Therapeutics and Core Natural Resources, and one to avoid

StockStory has named two cash-generating stocks to watch and one to avoid, arguing that strong cash flow alone does not guarantee good returns. It passes on Simply Good Foods, the maker of Atkins products. Revenue grew 5.2% annually over three years, sales are estimated to fall 9.9% in the next 12 months, and operating margin dropped 31.9 percentage points. The stock trades at $11.12, or 6.5x forward earnings. United Therapeutics, with a free cash flow margin of 34.6%, grew revenue 14.7% a year over five years and posts a 29.1% return on capital. It trades at $541.55, or 18.3x forward earnings. Core Natural Resources, a coal miner with a 6.1% free cash flow margin, grew revenue 15.6% annually over ten years to $4.27 billion. Its shares cost $89.05, or 20.7x forward earnings.

PYMNTS
Oct 14th, 2026
Liquidia, United Therapeutics reach $381 million deal to end lung drug litigation.

Liquidia, United Therapeutics reach $381 million deal to end lung drug litigation. By CPI | October 14, 2026 Liquidia has agreed to pay approximately $380.7 million to United Therapeutics and other parties to resolve a yearslong legal conflict over its lung disease treatment Yutrepia, ending six lawsuits involving patent infringement, trade secrets, contractual disputes and antitrust allegations. The settlement, announced Tuesday, allows Liquidia to continue selling Yutrepia for pulmonary arterial hypertension, or PAH, while requiring the company to stop promoting and commercializing the treatment for pulmonary hypertension associated with interstitial lung disease, known as PH-ILD, according to Reuters and company disclosures. The agreement marks the conclusion of a prolonged dispute between two competing developers of treprostinil-based treatments. Liquidia's Yutrepia is a dry-powder inhaled formulation of the drug, while United Therapeutics markets the competing Tyvaso franchise. Under the financial terms disclosed by Liquidia, the company will make an initial net payment of $175 million to United Therapeutics within 30 business days. Two additional installments of $72.7 million each are scheduled for January 31 and April 30, 2027. Liquidia will separately pay $60.3 million in October to parties holding interests in related antitrust litigation involving Treprostinil Injection. Together, the payments represent the approximately $380.7 million settlement cost. Deal follows Delaware patent ruling. The settlement comes two weeks after a federal court in Delaware ruled against Liquidia in a patent dispute concerning Yutrepia's use for PH-ILD. On September 30, the court found that two claims of United Therapeutics' U.S. Patent No. 11,826,327 were valid and infringed by Liquidia. The patent covers methods of treating PH-ILD with inhaled treprostinil, including dry-powder formulations. As part of the settlement, Liquidia agreed not to appeal the decision and submitted a request to the U.S. Food and Drug Administration to remove the PH-ILD indication from Yutrepia's approved labeling. The company also agreed to discontinue clinical trial cohorts investigating Yutrepia for PH-ILD and stop publication of related study data, according to a United Therapeutics regulatory filing cited by Reuters. The settlement includes mutual legal releases and does not constitute an admission of liability by either company. Following the initial payment, the companies are expected to file documents formally dismissing the pending litigation with prejudice, preventing those claims from being brought again between the parties. The six proceedings span patent infringement allegations, claims involving the alleged misuse of trade secrets, contractual disputes and antitrust litigation concerning treprostinil products. Yutrepia retains access to key treatment market. The commercial provisions are central to the agreement because they preserve Liquidia's ability to compete in PAH, even as the company relinquishes its position in PH-ILD. PAH is a progressive disorder involving elevated blood pressure in the pulmonary arteries. PH-ILD, by contrast, develops in association with lung diseases that cause inflammation and scarring. Please add Competition Policy International to your preferred sources list so its news, data and interviews show up in your feed. Thanks! Both conditions can be treated with inhaled treprostinil, making the two indications important to the commercial strategies of Liquidia and United Therapeutics. Yutrepia will remain available for PAH patients without interruption, Liquidia said. The company will also continue developing its broader clinical portfolio, including L606, an experimental extended-release treprostinil treatment being studied for PAH and PH-ILD. For United Therapeutics, the restrictions on Yutrepia reduce competition for Tyvaso in the PH-ILD market. Jefferies analyst Roger Song said the agreement could improve visibility into the future growth of the Tyvaso franchise, according to Reuters. Liquidia plans to fund payments through existing operations. Liquidia said it expects to finance the settlement through existing cash holdings and ongoing Yutrepia sales rather than seek additional capital. The company reported preliminary, unaudited Yutrepia net product sales of $222.7 million for the third quarter of 2026 and cash and cash equivalents of $396.1 million as of September 30. Chief Operating Officer and Chief Financial Officer Michael Kaseta said the company expects to meet its settlement obligations while continuing to invest in its commercial operations and clinical programs. Liquidia also terminated a promotional agreement involving Treprostinil Injection and will cease commercial support for that product as part of the broader resolution of the antitrust-related matters. The agreement drew a positive response from analysts, who viewed the removal of legal uncertainty as significant for Liquidia's commercial outlook. JPMorgan analyst Jessica Fye said the financial payment was more favorable to United Therapeutics than expected, according to Reuters. Liquidia shares rose nearly 37% in premarket trading Wednesday after losing more than half their value following the September court decision.