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Study Director

3 months ago

West Sacramento, United States RPM ReSearch Full time
Job DescriptionJob Description

Study Director-Drug Discovery


Job Description



Join Our Cutting-Edge Team in Sacramento, California: Study Director- Drug Discovery




The Opportunity:


How would you like to pioneer a significant role in an exciting new division of a leading life sciences R&D provider? With a vision to revolutionize our business, and delve into novel research areas, we invite you to seize this golden opportunity and contribute to our bold ambitions.




About Us:


For over 25 years, At our client's growing CRO, we have united in our mission to accelerate the discovery, development, and production of new drug therapies, ensuring they reach those in need more swiftly.


This site was initially focused as a CDC quarantine facility but has grown to a center of excellence for discovery phase biopharmaceutical studies focusing on NHPs for non-GLP gene therapy, early discovery studies, and model development.


The site offers a flexible and dynamic work environment where staff can engage in various aspects of research, working closely with sponsors both virtually on onsite. The work environment is friendly and on the smaller side with 35 employees, so you will get to know everyone by name and have access and visibility to senior management. But dont let the size fool you, this is one of 4 large animal research facilities across the country giving you access to a wider variety of scientific expertise and the ability to collaborate with colleagues.



As a study director, You will be allowed to work on a variety of different studies such as cell and gene therapy, pharmacology, early discovery Non-GLP, and model development.








Your Role and Impact:


As Study Director, you'll provide pivotal oversight for in-vivo studies focused on immunology dealing with NHP models.





Key Responsibilities:


Responds to inquiries from clients and other relevant parties regarding scientific aspects


of studies. Actively participates in client discussions regarding studies.


Serve as scientific expert for studies during audits, on project teams, committees, and


other assignments.


Functions as departmental representative for interdepartmental communications and


initiatives as required.


Designs and/or implements new experimental approaches to support studies and develop


new capabilities for the company.




Functions as an independent Study Director with overall responsibility for the technical


conduct of assigned studies.




Demonstrates the ability to plan complex study designs by effectively utilizing available


information and technical expertise.Consult with Sponsors, contributing scientists, and other key individuals during Protocols and guidelines.



Description:




Coordinates all phases of a nonclinical study in collaboration with internal departments,


external vendors, and clients.


Confirms with management that study personnel have the training and education to


perform their assigned function(s).




Prepares the Project Review Form and obtains approval of the study by the IACUC.


Monitors, and communicates study milestones effectively to all contributors


(internal and external), including the Sponsor.


Assures that all experimental data, including observations of unanticipated responses of


the test system, are accurately recorded and verified.


Assures that unforeseen circumstances that may affect the quality and integrity of the


nonclinical laboratory study are evaluated for their potential impact on the study and


communicated to the Sponsor.


.


Stays informed of current industry practices through research and review of scientific


literature and regulatory documents.


Reviews and presents data from assigned studies in a comprehensive manner to peers.


Mentors technical staff in areas such as protocol interpretation, method development


and refinement, and study-related problem resolution.


Serves as a mentor to other scientists and assists in the training of new scientist staff.



What We're Looking For:


A Ph.D. degree coupled with 3+ years of laboratory animal research experience. Post-doctoral graduates are welcome to apply.


In Vivo and Immunology experience.


CRO experience is a plus but not required.


NHP experience is a plus but not required.






Make Waves in Sacramento


This role is more than just a jobit's a chance to reshape the landscape of life sciences and make history. Join us and be a part of our thriving community in the heart of Sacramento, California. You will have the opportunity to develop your career and skills.




Ready to embark on this exhilarating journey? Let's achieve wonders together.