Senior Product Development Scientist/Associate Director
Advanced Clinical
- Durham, NC
- Permanent
- Full-time
- 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 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
- 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
- Master’s degree or
- Doctor of Pharmacy (PharmD) or
- Doctor of Philosophy (PhD)