Principal Scientist, Clinical Process Development

Neurocrine Biosciences • San Diego, CA

1d

About The Position

About the Role: Responsible for leading the advancement of assigned assets from pre-clinical through commercial phases, including internal process or product development experimentation and collaboration with external partners for development and manufacturing. Good working understanding of investigational product handling in a clinical setting is required. Advanced scientific contributions are required to enable process establishment, optimization, and characterization to ensure robust delivery of the pipeline. The position also entails contribution to regulatory documentation, quality and cGMP knowledge, and an ability to build strong relationships with cross-functional and external partners. May train and mentor other scientists and/or team members.

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 OR MS/MA in pharmacy, chemistry, biochemistry, biology, or similar scientific discipline and 6+ years of similar experience noted above OR 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

Nice To Haves

• Experience with patient handling, usability, or human factors is a plus
• Experience working with CROs, clinical sites, investigators, and external vendors is a plus

Responsibilities

• Strategizes and oversees clinical in-use studies to assess material compatibility, in-use shelf life, and define the appropriate clinical handling procedures for investigational products
• Design, author, and oversee the execution of Pharmacy Manuals supporting early-phase clinical trials
• Contributes to clinical protocol design, amendments, and execution of studies assessing dosing, administration, and product handling
• Apply advanced scientific principles to complex challenges in product development lifecycle encompassing definition, optimization, characterization, and validation
• Plans and manage projects.
• 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

Benefits

• Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree