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Senior Clinical Drug Development Scientist / Clinical Drug Development Associate Director

United Therapeutics

Research Triangle Park, NC

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JOB DETAILS
SKILLS
Biotech and Pharmaceutical, Budgeting, Cardiovascular Disease, Case Report Form (CRF), Clinical Practices/Protocols, Clinical Support, Clinical Trial, Consulting, Contract Research Organization (CRO), Customer Relations, Data Collection, Data Management, Database Administration, Disease, Disease Investigation, Diversity, Drug Development, Drug Products, Electronic Publishing, Energy & Utilities, Entrepreneurship, Establish Priorities, FDA (Food and Drug Administration), FDA Requirements, GCP (Good Clinical Practices), Healthcare, ICH Regulations, Informed Consent, Medical Products, Microsoft Office, Organ Transplant, Pharmacokinetics, Pharmacy, Phase I Clinical Trials, Phase IV Clinical Trials, Philosophy, Pre-Clinical Trials, Presentation/Verbal Skills, Product Development, Product Testing, Project Development, Project Planning, Project/Program Coordination, Project/Program Management, Protocol Design, Publications, Pulmonary Disease, Realtime Transport Protocol, Regulations, Regulatory Requirements, Regulatory Submissions, Reporting Skills, Research & Development (R&D), Standard Operating Procedures (SOP), Sustainability, Team Player, Vaccination, Viruses, Work From Home, Writing Skills
LOCATION
Research Triangle Park, NC
POSTED
30+ days ago
California, US residents click here (https://www.unither.com/docs/UNITHER%20Applicant%20Notice%20-%20%2812-22-23%29%20Final%202.15.24%20Combined%20EN%20and%20French.pdf#page=9) .


The job details are as follows:


Who we are


We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.


United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter’s pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF).


The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.


Who you are


We are seeking a highly motivated Clinical Drug Development Scientist to join our team. You will support the design, implementation, and oversight of early to late-phase clinical trials. The successful candidate will have experience with designing clinical studies, authoring protocols and general proficiency with drug development strategy.


The Clinical Drug Development Scientist will assist with the coordination, management and execution of Phase I through Phase IV clinical studies and support the conduct of preclinical studies to ensure the successful submission and approval of a drug product by regulatory agencies. This role will provide scientific insight into study design and disease process, and lead protocol development and writing.


Minimum Requirements


+ For Senior Clinical Drug Development Scientist level:

+ 10+ years of pharmaceutical company experience in clinical drug development with a bachelor's degree or

+ 8+ years of pharmaceutical company experience in clinical drug development with a master's degree or

+ 5+ years of pharmaceutical company experience in clinical development with a PhD/PharmD

+ For Clinical Drug Development Associate Director level:

+ 10+ years of product development experience with hands-on experience managing across Phase 1-4 clinical trials with a master's degree or

+ 7+ years of product development experience with hands-on experience managing across Phase 1-4 clinical trials with a PharmD/PhD/MD

+ Demonstrated understanding of the overall drug development process with clinical trial design, study implementation, sponsor/site interactions, external committee management (DMC, Steering Committees), scientific and clinical methodology, protocol design, project management and regulatory requirements for clinical studies to be reviewed by health authorities

+ Knowledge of GCP, ICH, and PhRMA guidelines

+ Knowledge of relevant FDA regulations and guidelines

+ Ability to work independently, prioritize tasks efficiently and meet expected timeframes


Preferred Qualifications


+ Master’s degree or

+ Doctor of Pharmacy (PharmD) or

+ Doctor of Philosophy (PhD)


Job Location & Travel


This position is located at our Durham, NC office. Currently this is a hybrid role requiring at least four days per week in the office. In office requirements could increase based on business needs. This position has a travel expectation of up to 20% and can include both domestic and international travel.


At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good.


Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities


United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.


_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 job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work._

About the Company

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United Therapeutics

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