Principal Scientist, In Vivo Pharmacology

Kelly® Science & Clinical is seeking a Principal Scientist, In Vivo Pharmacology for a direct-hire position at a cutting-edge client in San Diego, CA. If you’re passionate about advancing scientific discovery and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Pay: $160k

Schedule: Hybrid with 1-2 days’ work from home

Overview

Our client, an industry leader in pharmaceutical research, specializes in small molecule development and is dedicated to pushing the boundaries of scientific exploration. In this role, you’ll play a critical part in designing and executing in vivo preclinical studies, ensuring strict compliance with regulatory guidelines and fostering a collaborative environment.

Responsibilities:

Study Design and Execution

• Serve as the primary Study Director for pre-clinical studies and other designated research projects.
• Develop, review, and endorse study protocols, amendments, and schedules in accordance with regulatory guidelines and client specifications.
• Utilize business acumen to ensure accurate study quotations, efficient resource allocation, and effective protocol management.
• Maintain strict adherence to protocols, SOPs, and relevant regulatory standards throughout the study lifecycle.
• Act as the principal liaison for communication between clients and internal departments.
• Lead pre-initiation meetings and other study-related discussions.
• Oversee the preparation and finalization of comprehensive study reports, ensuring accuracy and completeness.
• Manage study files, documenting all correspondence, schedules, and protocol deviations.
• Provide timely and professional responses to audit reports and client inquiries.
• Oversee anesthesia administration, euthanasia procedures, and the handling of biological samples, ensuring proper storage and disposal.
• Provide technical expertise in drug formulation, dosing techniques, and necropsy.

Leadership and Mentorship

• Mentor and train technical staff in advanced laboratory techniques.
• Promote a positive and innovative work environment through cross-functional collaboration.
• Oversee complex project design and execution, ensuring high-quality outcomes.

Compliance & Regulatory Affairs

• Ensure compliance with GLP and non-GLP standards and assist with USDA and FDA inspections.
• Work closely with Quality Assurance & Compliance professionals to prepare and submit documentation for regulatory approvals.
• Play an active role in USDA and FDA inspections, ensuring all study activities meet federal regulatory standards.
• Participate in AAALAC inspections, to support the maintenance of accreditation standards for laboratory animal care.
• Effectively collaborate with the Institutional Animal Care and Use Committee (IACUC) to review and gain approval of Animal Care and Use Protocols (ACUPs).
• Author, review, and edit SOPs to standardize laboratory practices, including EHS considerations.
• Maintain meticulous laboratory records, ensuring accurate and up-to-date documentation.

Data Analysis and Reporting

• Analyze and interpret data, preparing detailed reports and managing data finalization.

Laboratory and EHS Management

• Maintain lab organization and oversee equipment calibration, inventory, and safety.

Qualifications:

• Ph.D. in Pharmacology, Biology, or related field or Doctor of Veterinary Medicine (DVM) degree.
• DABT Required; additional certifications in animal care or project management are advantageous.
• Minimum 5 years in an animal-related field, with expertise in GLP and non-GLP studies.
• Demonstrated expertise in Investigational New Drug (IND) application preparation and filing process.
• DEA certification for handling-controlled substances.
• Certified Laboratory Animal Technologist (LATG) through the American Association for Laboratory Animal Science (AALAS) or equivalent advanced certifications
• Six Sigma certifications, such as Green Belt or Black Belt.
• Project management certifications, such as Project Management Professional (PMP) or Certified associate in project management (CAPM).

What happens next:

Once you apply, we will review your qualifications to assess your fit for this role. If selected, you’ll move forward in the hiring process. If this role isn’t a match, joining our network connects you with a range of future opportunities.