San Diego, CA30+ days ago
Requirements: • BS/BA in pharmacy, pharmaceutical sciences, chemistry, biochemistry, biology, or similar scientific discipline and 8+ years of experience in formulation research, clinical research, experience managing laboratory, maximizing productivity is desirable • ORMS/MA in pharmacy, chemistry, biochemistry, biology, or similar scientific discipline and 6+ years of similar experience noted above • PharmD or PhD in Pharmaceutical Sciences or similar scientific discipline and 4+ years of relevant experience; may include fellowships in academia or industry • Experience supporting clinical trials, especially in-use/actual-use studies • Familiarity with clinical protocol development, amendments, and clinical study reports • Good understanding of GCP, GLP, and relevant FDA/ICH guidance • Experience with patient handling, usability, or human factors is a plus • Experience working in a regulated environment • Excellent laboratory and productivity skills • Experience working with CROs, clinical sites, investigators, and external vendors is a plus • Demonstration of cross-functional understanding related to drug development • Advanced knowledge and demonstrated ability to work with / recommend a variety of laboratory equipment/tools • Maintains broad knowledge of scientific principles and theories and possesses intellectual mastery of one or more scientific areas • Develops and drives creative solutions to technical challenges • May develop an understanding of other areas and related dependencies • Ability to work as part of and lead multiple teams • Exhibits leadership skills, typically leads junior levels and/or indirect teams • Excellent interpersonal communications, problem-solving, and analytical thinking skills • See broader picture, impact on multiple programs, teams and/or departments • Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency • Excellent project management skills. Represents development in cross-functional teams • Maintains accountability for deliverables including production plans for development projects • Independently designs, plans and executes advanced activities towards the goals of one or more development projects to support preclinical through commercial activities • Supervises laboratory work and/or lab personnel and ensures safe laboratory practices • Proactively identifies process or product challenges and drives necessary optimization activities including trouble-shooting experimentation • Identifies and recommends novel approaches to improve product quality, product stability, or to achieve cost effectiveness • Manages contract manufacturing activities and directly interacts with contractors • Author or contribute to clinical protocols, study reports, regulatory briefing documents, and responses to health authority questions • May provide supervision of laboratory personnel and guidance for their professional development • Build and enhance internal and external professional relationships • Other duties as assigned.