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
The Strategic Development Clinical Operations Manager is responsible for the execution of study-level activities including but not limited to creating and updating trial-specific documents, vendor oversight & delivery, compound training and country and regional oversight of CRO operational delivery through trial close out in compliance with UT processes and GCP/ICH and regulatory requirements. This individual will have a strong background in clinical development and clinical trial management with the ability to operate independently in a fast-paced environment.
Manage integration of project team activities, leveraging internal and external resources, expertise and knowledge, along with optimizing CRO resources, expertise and knowledge
Provide input on trial level operational strategies for clinical trials from protocol design to the final clinical study report for specified studies
Provide input into global subject/patient recruitment plans
Relationship management between study sites and vendors
Manage aspects of CRO/vendor identification and the day to day operational management activities of CROs & other vendors including set up, statement of work creation and budget oversight
Manage strategic study operations including: study sites and tracking systems for regulatory submissions, drug supply and use, enrollment of subjects, regulatory document flow, study timelines, all budgetary and financial information, performance metrics and data flow
Create and update critical trial-specific documents and plans
Support development of compound and protocol level training materials
Review and provide input into budgets, timelines, and forecasts for assigned clinical studies
Interface with internal key stakeholders including, but not limited to; Finance, Safety, Quality Assurance, Operations, Regulatory, Product Development, Medical Affairs; which may include acting as a liaison between groups
Provide support for inspection readiness activities and on identification of risks and mitigation plans at the trial level
Participate in process improvement activities at a trial and department level as needed
Perform other duties as needed and assigned
For this role you will need
Minimum Requirements
Bachelor's Degree in life sciences or relevant scientific discipline
8+ years of clinical research experience gained with a CRO, Biotech, or Pharmaceutical Company working on Phase 1-3 global clinical trials with a Bachelor's degree or
6+ years of clinical research experience gained with a CRO, Biotech, or Pharmaceutical Company working on Phase 1-3 global clinical trials with a Master's degree
2+ years leading aspects of global clinical trials
Experience with all trial components supporting Phase 1-3 studies
Computer literate with experience in Microsoft software suite and other relevant packages
Knowledge of Good Clinical Practice, regulatory processes, and clinical development processes
Demonstrated & reproducible results in clinical operations
Demonstrated ability to resolve issues with minimal supervision, and to understand when to escalate
Embraces training, mentoring and professional development of staff
Ability to work effectively under pressure
Ability to influence without authority
Ability to resolve issues with minimal supervision, escalating as needed
Demonstrated negotiation and conflict resolution skills
Advanced experience with successful collaboration across functions in a matrix environment
Project Management experience
Experience with Microsoft Office product suite required
Preferred Qualifications
Master's Degree in life sciences or relevant scientific discipline
3+ years of people management experience
Job Location
This hybrid role is located in Durham, NC, and requires at least four in-office days a week. Expected travel for this role is up to 20%
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.
