Study Director (In-Vivo) - Simply Biotech - TalentZok
San Diego, CA
About the Job
Study Director (In-Vivo)- Simply Biotech
OVERVIEW
Are you looking for a new career opportunity with an exciting biotech company?! Then we've got the right team for you! In this role, you're responsible for the duties listed below.
Immediate opening for a Study Director (In-Vivo) with a biotech company in San Diego, CA who possesses:
- 8+ years of experience as a Study Director or Principal Investigator in pre-clinical studies or related research fields.
- Must have CA vet license or plan to obtain it within 1 year of joining company
- Prior experience in a research or vivarium setting is preferred.
- Previous experience in GLP-regulated environments
- Prior management experience (will be managing 15-20 reports)
Email resumes to kbrace@simplybiotech.com or call 858.683.8559
FULL DESCRIPTION: We are seeking an experienced Study Director with a Doctor of Veterinary Medicine (DVM) to join our innovative Research and Development team. This role is crucial in overseeing the colony management of small and large animals, driving Vivarium Operations, and ensuring the successful execution of research studies. The ideal candidate will bring expertise in surgical procedures, study design, business acumen, and leadership to support high-impact research initiatives. Responsibilities include overseeing study quotations, resource allocation, protocol adherence, and department revenue while mentoring other Study Directors, developing training programs, and driving continuous improvements. The role also involves evaluating current processes, streamlining husbandry operations, and enhancing overall operational efficiencies. The Attending Veterinarian/Study Director will work closely with the Business Development team to support study quotations and design.
The selected candidate will be responsible for:
- Oversee all studies to ensure they are conducted efficiently, effectively, and within 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.
- 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.
- Licensed to practice veterinary medicine in California, required.
- Doctor of Veterinary Medicine (DVM) degree from an accredited institution, required.
- DACALM Certification preferred (Diplomate of the American College of Laboratory Medicine) preferred.
- Ph.D. in a relevant field, such as toxicology, pharmacology, or biomedical sciences, preferred.
- Board certification in a relevant surgical specialty is highly desirable.
- Extensive experience in conducting surgical procedures on laboratory animals.
- Strong knowledge of biomedical research methodologies and objectives.
- Exceptional communication, collaboration, and business acumen.
- Proven leadership skills, with the ability to mentor and develop others.
- Ability to excel in a fast-paced, dynamic research environment.
- Optional but desired: Diplomate of the American Board of Toxicology.
The selected candidate will also possess:
- 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
For immediate and confidential consideration, please email your resume to kbrace@simplybiotech.com or call 858.683.8559. More information can be found at www.simplybiotech.com
Source : TalentZok