Clinical Outcomes Director jobs in North Carolina

OVERVIEW

We are currently searching for a skilled professional to join a well-known client's team as a Senior Product Development Scientist/Associate Director. The Sr. Product Development Scientist/Associate Director 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. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.

RESPONSIBILITIES

• 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

EXPERIENCE

• For Senior (Clinical) 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 (Clinical) 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

EDUCATION

• Master's degree or
• Doctor of Pharmacy (PharmD) or
• Doctor of Philosophy (PhD)

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.

Regarding your application

Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.