Senior Product Development Scientist/Product Development Associate Director

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. How you’ll contribute 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 is a hybrid position with 4 days a week onsite in our RTP, NC office and 1 day a week work from home. Independently perform the following responsibilities under the direction of the Product Development Manager and/or Program Head to coordinate, manage, and lead the overall execution of clinical studies or group of clinical studies while following appropriate GCPs and SOPs: Provide scientific insight into study design and disease process; Lead protocol development and writing; Develop the case report forms (CRF) for collection of patient data; Supervise the informed consent composition; Review consultant reports (e.g., pharmacokinetics reports); Oversee database generation and production of tables and listings; Ensure clinical trial material (CTM) is available for sites and/or Contract Research Organizations (CRO); Lead final clinical study report writing to summarize the methods and results; Work with other internal functional areas (e.g., Regulatory, Safety, Data Management) to support the study Independently perform the following responsibilities under the direction of the Product Development Manager and/or Program Head to support the conduct of preclinical studies: Review protocols and reports in conjunction with the preclinical department; Review consultant reports (e.g., pharmacokinetics/toxicokinetics) Perform the following tasks related to clinical product development with limited oversight: Work with Program Head to lead the generation and updates of the clinical investigator brochure; Draft publications (e.g., abstracts, posters, manuscripts); Assist in the evaluation of new products and in-license opportunities; Participate in preparation of regulatory submissions (e.g., IND, NDA, sNDA); Assist with project planning, including developing project timelines and budgets; Provide scientific literature review; Participate in interactions with Steering Committees, Advisory Committees, Data Monitoring Committees, and Publication Committees in conjunction with the Project Leader; Maintain SOPs, GCPs, training, and continuing education Perform all other duties as required For this role you will need Minimum Requirements For Senior Product Development Scientist level: Bachelor’s degree with at least two years of relevant clinical development experience 10 years of pharmaceutical company experience in clinical development with a bachelor's degree or 8 years of pharmaceutical company experience in clinical development with a master's degree or 5 years of pharmaceutical company experience in clinical development with a PhD/PharmD For Product Development Associate Director level: Master’s degree or 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, 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 time frames Ability to interact collaboratively with various departments, regulatory agencies and investigators Strong communication (oral and written) and analytical skills Proficient in Microsoft Office Preferred Qualifications Master’s degree or Doctor of Pharmacy (PharmD) or Doctor of Philosophy (PhD) 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 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.