Study Director

2 days ago

San Diego, California, United States Simply Biotech Full time
Job Title: Study Director

Job Summary:

We are seeking an experienced Study Director to join our Research and Development team at Simply Biotech. The ideal candidate will have a strong background in veterinary medicine, research, and leadership, with a focus on pre-clinical studies and laboratory animal care.

Key Responsibilities:

  • Oversee the conduct of studies to ensure efficiency, effectiveness, and regulatory compliance.
  • Act as the Study Director/Principal Investigator for designated projects and serve as a backup Study Director when needed.
  • Mentor and oversee other Study Directors on study quotation, design, and execution.
  • Develop, implement, and continuously improve Study Director training programs.
  • Evaluate current processes and recommend improvements to streamline operations and enhance efficiency.
  • Manage efficient resource allocation, accurate study quotations, and cost-effective study designs.
  • Collaborate closely with the Business Development team on study quotation and design, ensuring alignment with client needs and company capabilities.
  • Serve as the key point of contact for clients, and internal teams, ensuring clear communication and strict protocol adherence.
  • Uphold the ethical and humane treatment of animals, ensuring compliance with all welfare standards and implementing effective pain management and post-operative care protocols.
  • Develop, review, and endorse study protocols, amendments, and schedules in accordance with regulatory guidelines and client specifications.
  • Lead pre-initiation meetings and other study-related discussions.
  • Manage study files, documenting all correspondence, schedules, and protocol deviations.
  • Utilize business acumen to ensure accurate study quotations, efficient resource allocation, and effective protocol management.
  • Oversee the preparation and finalization of study reports, ensuring documentation accuracy and thoroughness.
  • Respond promptly and professionally to audit findings and client inquiries.
  • Perform and oversee complex surgical procedures on laboratory animals, with a preference for Non-Human Primates (NHP) and other large mammals.
  • Maintain proficiency in diverse surgical techniques aligned with research objectives.
  • Supervise the care and management of laboratory animal colonies, ensuring compliance with AAALAC, USDA.
  • Develop and implement health monitoring programs to ensure the well-being of research animals.
  • Provide primary veterinary care and medical treatment as needed, focusing on animal welfare and disease prevention.
  • Streamline husbandry operations to improve efficiency and animal care.
  • Maintain and inspect vivarium facilities ensuring compliance with regulatory standards.
  • Collaborate with researchers in both the In Vivo & In Vitro departments and other team members to design and execute studies that align with research objectives and business goals.
  • Conduct standard physical evaluations and provide expertise in research proposal development, aligning with business objectives.
  • Offer input and expertise in the development of research proposals and grant applications.
  • Collect, record, and maintain accurate data related to surgical procedures and outcomes, ensuring regulatory compliance.
  • Train research staff on veterinary, surgical, dosing, and sampling techniques, promoting best practices and continuous learning within the team.
  • Stay informed on advancements in surgical procedures and share knowledge with colleagues.
  • Develop and implement continuous improvement initiatives for study directors and operational processes.
  • Ensure adherence to all relevant regulations, ethical standards, and guidelines, collaborating with regulatory affairs professionals for documentation and approval processes.
  • Monitor and ensure that all studies comply with regulatory standards, addressing any deviations promptly.

Requirements:

  • Minimum of 4 years of experience as a practicing veterinarian with a focus on survival surgery.
  • Minimum of 8 years of experience as a Study Director or Principal Investigator in pre-clinical studies or related research fields.
  • Prior experience in a research or vivarium setting is preferred.
  • Previous experience in GLP-regulated environments is highly preferred.

Salary Range: $250k-$260k/yr

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