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Study Director Toxicology & Pharmacokinetics

Boulder, Colorado
Job Type
13 Jun 2022

Study Director - Boulder, CO

Inotiv, Inc. is a contract research organization that provides pre-clinical refs supporting our clients' discovery and development objectives for improved decision-making and accelerated goal attainment. Inotiv Colorado provides a variety of specialized services including histology, pathology, IHC, brightfield imaging and analysis projects. Our In vivo services specialize in models of inflammation, fibrosis, and autoimmune conditions with specific focus on the circulatory, renal, immune, digestive and nervous systems. We have three sites, two located directly in the Boulder Foothills, and one in Westminster, CO, between Denver and Boulder. Our team of leading scientists are driving business to be the best-in-class partners to our vendors.

We are looking to build our team of Study Directors at our Boulder, CO site and have an immediate opening for a Study Director of Toxicology & Pharmacokinetics.

Job Summary and Essential Functions:

The position has responsibilities centered around the execution, planning and management of assigned studies. The ability to communicate succinctly with clients, coordinators, and technicians is key as is a cross-functional, flexible, and collaborative spirit. The successful candidate will have direct knowledge of the time and costs associated with a given amount of scientific work, can communicate their scientific expertise to key stakeholders of client companies, and can execute multiple, concurrent studies in a timely fashion that matches business demand. The right candidate will help manage client projects to ensure they meet client expectations and deadlines along with assisting with business development activities.

The position demands an in-depth understand and working knowledge of translatable pre-clinical drug discovery and development with a focus on Toxicity, tolerability, and pharmacokinetics.

Job Summary and Essential Functions

  • Acts as the main liaison between external clients/sponsors and the internal scientific team
  • Owns and provides leadership for all aspects of the appropriate proposal process (text, quote, budget, and/or response to requests for information) for assigned opportunities, inclusive of managing opportunities autonomously, establishing clear timelines, meeting client requirements, and resolving obstacles
  • Reviews and analyzes client inquiries and documents to ensure adequate information for budget, protocol and proposal preparation is provided. Follows up with appropriate contact for additional information as required.
  • Identifies and resolves issues around client's requirements and the company's capabilities
  • Provides information to the client and scientists concerning standard testing programs, sample preparation, sample submission requirements, program coordination and associated documentation.
  • Perform in-depth analysis of client issues in order to remediate or prevent client dissatisfaction and develop and maintain customized client communication for all therapeutic areas.
  • Oversees and participates in final Technical Report writing
  • Maintain client communication files in an electronically accessible format, in conjunction with principal investigators, develop project timelines and milestones according to the client's needs.
  • Keep track of project timelines for forecasting purposes. Be able to communicate forecasting information in a format usable to other internal departments.
  • Prepares high quality and accurate documents; collaborates with the review team to ensure the responses and strategy meet the sponsor requirements and expectations in the face of changing timelines; based on experience, proactively proposes appropriate potential strategies
  • Identifies and is accountable for driving ways to improve the efficiency and quality of processes and the resulting deliverables, influencing key stakeholders as applicable
  • Performs timely and accurate data entry into departmental and/or corporate databases/systems as appropriate
  • Assist with pricing of new methods during contract/proposal development and manage project process to identify changes in scope that would require revisions to contracts.
  • Performs quality control activities per the appropriate process/requirements

Management and Team:

  • Reports to and works closely with Senior Directors
  • Manages one or more Study Coordinator and/or Lead Animal Research Technician
  • Establishes and maintains training and development objectives for direct reports

What we're looking for:

  • An individual with an in-depth understanding of in vivo models of multi-system rodent physiology and in vitro analyses of pathobiology and disease biomarkers.
  • Demonstrates strong organizational, communication, time management, and interpersonal skills in a cross-functional team.
  • Able to demonstrate strong skills in authoring and managing the production of scientific documents (pre-clinical study protocols, proposals, technical reports, pharmaceutical regulatory documentation and/or publications in peer-reviewed journals).
  • Works collaboratively with others to maintain a safe environment.

Working Conditions:

  • May involve typical office environment and a laboratory setting with potential direct exposure to/handling of laboratory animals
  • Work from home with occasional travel to company facility may be available
  • Typical hours 8am-5:30pm M-F with non-standard hours, evening and weekend work occasionally required

Minimum Education / Experience Requirements:

  • Clinical, preclinical research or scientific experience in one or more of our therapeutic areas is strongly desired: toxicology, pharmacokinetics, inflammation, fibrosis, autoimmune, circulatory, renal, immune, digestive and nervous systems
  • Ph.D. degree in related discipline (Physiology, Biochemistry, Pharmacology, etc.) and at least 1 years of related post-doctoral experience (Preferred).
  • MS degree in related discipline (Physiology, Biochemistry, Pharmacology, etc.) and at least 1 years of related experience or an equivalent combination of education and experience (Required).
  • Previous physiological, pharmacological or life sciences laboratory experience desired.

What we offer:

  • This will be an exempt position and salary range of $90,000 to $150,000 annually, commensurate with your education, experience, and certification.
  • Our benefits package will include health/dental/vision insurance, life and disability insurance, 401k Retirement Plan with employer matching, stock options, paid holidays, vacation, personal and sick leave, 12 weeks paid parental leave, and an enormous opportunity for training and professional growth
  • Relocation assistance available

Please apply directly to our website at .

Inotiv is an equal opportunity and E-verify employer.

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  • Job Reference: 623860217-2
  • Date Posted: 13 June 2022
  • Recruiter: INOTIV
  • Location: Boulder, Colorado
  • Salary: On Application
  • Sector: Healthcare & Medical
  • Job Type: Permanent