Research Development Associate Jobs in Waterloo, ON

This role is a temporary 18 - Month contract.

Job Summary

The Scientific Director (SD)is the primary individual responsible for the management and integrity of the design, conduct, and reporting of a research project and for managing,monitoringand ensuring the integrity of Sponsor relationships. The SD is charged to conduct objective research that generates independent, high quality, and reproduceable results. Additionally, the SDis responsible forthe direction and oversight of regulatory compliance, compliance withTranspharmationand Sponsor policy, financial, personnel, and other related aspects of the research project. The SD will have a solid understanding ofeach individual'sroles and responsibilities within the company and within research studies. The SD will also be involved in business development working closely with the Chief Scientific Officerand the Sales team. The SD will also work closely with the Chief Scientific Officer to help guide scientific development/advancement of company services.The SD may also be recognised as having specialist knowledge in a particular therapeutic or platform technology area. As such, the individual may be called up to act as an expert tofacilitatesponsor interactions,and alsoto provide insights into market trends and scientific developments to support service growth. The SD may also be expected toinitiateand oversee internal studies for this purpose. Contribution to the publication of scientific materials either through newsletters, peer reviewed journals and/or formal presentations at scientific meetings is also expected.

DUTIES AND RESPONSIBILITIES

Key Activities

• Create study proposals outlining summary of study design anddeterminecost of studies for quotations.

• Ability to work with clients todeterminewhetherTranspharmationcan meet theclient'sneeds.

• Provide Scientificexpertiseto clients by introducing efficacy animals models that provide translational value and help accelerate the clients' research programs.

• Optimizestudy and costing procedures by increasing efficiency, ensuring cost recovery, and reaching the company's projected profit goals.

• Develop study protocols, overseeprojects,and prepare final reports on contracted studies.

• Collaborate with client and Study Coordinator toestablishan appropriate studydesign based onclient'sneeds.

• Act as a bridge between client and operations throughout the study, keeping both parties informed of progress andfeedbackas necessary.In the event ofdeviations/unforeseen issues be able to effectively communicate between internal and external contacts.

• Maintain close communication with business development and finance departments for client accounts and invoicing upon each milestone.

• Evaluate resources based on the workload and proactivelyanticipateandallocateadditionalresources ifrequired.

• Develop andoptimizestudy and costing procedures.

• Develop new study models based on market interest/requirements.

• Ensure quality standards aremaintainedwith respect to project deliverables and Sponsor interactions.

• Provide a level of scientific interaction to enable discussions with client to move forward effectively. Also to be able to understand where client needs may not be met.

• In discussion with CSO/otherSDsbe prepared toidentifyand discuss areas for future assay development within that area for the purpose of revenue growth.

• Provide advice re. study pricing to Sales/Marketing (costultimately determinedby Sales but the SD should be able to comment on final pricing and raise comment where necessary).

• Be available for internal discussions with sales team re. operational capacity, limitations, opportunities to meet emerging client needs.

• Complete cost amendments andsubmitto finance. Understand potential cost implications of study amendments and help advise the sales team onappropriate costimplications.

• Maintain close contact with relevant departmental managers to ensure leadership/composition of the team reflects market trends and demands.

• File study amendments/deviations/memos/incidentsas necessary.

• Perform technical procedural workand surgical proceduresasneeded(basic and advanced).

• Ensure that all experimental data, including unanticipated responses, are accurately recorded andensure completeness and integrity of data collected during the study.

• At study conclusion be able to provide interpretation of ongoing/completed studyresultsto the client and addressfeedbackas necessary.

• Ensuringappropriate analysisand interpretation of study outcomes.

• Together with SC and report writer, prepare a report and be prepared to sign-off when necessary.

• Providescientific insight to help developnew serviceofferings orhelp advance existing service offerings.

• Participate in internal working groups as requested (animal care committee,healthand safety, CTLS,etc).

• Other duties asdeemednecessary.

Supervisory

• Act as the company's primary resource in area of expertise, providing leadership direction on all related issues.

• Share technical and competitive information with colleagues and provideexpertiseto others whenrequired.

• Promote cooperation within own team as well as between groups and with other departments.

• Participate in business development activities as subject matter expert on areas of expertise.

• Represent and market company atscientific meetings and/or client site visitson an as-needed basis up to 10% US and international travel.

• Explain techniques to new employees and visitors.

• Provide training to staff asrequired.

• To form close dialog and trust with study coordinator(s) and the technical team.

• Ensure both studylogisticsand timelines are understood at all stages.

• Understand the current technical capability of internal resources.

• Provide hands-on support to technicalteamas necessary.

• Beaware of ongoing study issues and co-ordinate communication betweenTranspharmationand sponsor during the in-life study stage.

INTERACTION

This position requires the individual to serve as an important interface between internal departments (i.e.technical team, sales team, accounting team, other scientists,qualityassurance), as well as external groups, (i.e.Sponsors, scientific community, ACC). This position may also require the individual torepresentthe company at trade shows,conferencesand sales trips.The individual must therefore be well versed in communication skills.

COMMUNICATION

Communications are withalldepartmentsand employees within the organization as well as communication with externalcompanies. Collaboration, execution, and reporting of the quality assurance program. Verbal communicationisrequiredto requestandreceiveinstructions for work,to reporton activities, results, problems, and toparticipatein planning and scheduling of work and equipment use. Written communication isrequiredforaccurateand detailed recording of procedures, for reportingresultsand for completing documentation. Reading and comprehension ofscientific publications,writtenprotocolsand manuals is essential.

WORKING CONDITIONS

ENVIRONMENT

Generally working indoors.Occasional periods of several hours per day exposed to noxious odours from diagnostic materials and/or samples. There will also be the occasional need to work with chemicalsand/or biohazardsin a controlled environment.

RISK TO HEALTH

There will be the occasional exposure to small quantities of toxic irritant or corrosive chemicalsas well as exposure to freezers (-80C) and liquid nitrogen (-200C) while storing, retrieving, shipping, and receiving materials. There will be exposure to zoonotic diseases. There will also be repetitive physical activities.There will beoccasional periods of several hours per day performing physically repetitive procedures (typing, etc.).There is also a potential for digital eye strain resulting from prolonged computer use.

PHYSICAL REQUIREMENTS

PHYSICAL DEMANDS

The demands of this positioninclude:standing,bending, twisting,lifting, carrying liquid containers,carryingboxes weighing up to 20 kg and daily periods of keyboarding.

PHYSICAL DEXTERITY

Agility,accuracyand consistency will berequiredwhile handling precision instruments such as, pipettes, balances, pH meters, surgical instruments.Strong fine motor skills in fingers, hands, and arms.

Qualifications

EDUCATION

• Veterinaryor graduate level science degreeor B.Sc. degree in a relevant field (e.g.,Pharmacology, Pharmacokinetics, Veterinary Sciences, Biochemistry) with at least3years of direct experience.

• A higher degree ofmastersor PhD is consideredadvantageousbut not essential to the role.

Experience

• 3-5 years'experiencemanaging projects, research activities, and collaborative initiatives in a science delivery environment.

• Demonstrated experience and comfort in managing animal studies.

• Experience in the delivery of diagnostic or reference laboratory services under a system of quality.

• Experience in planning and managing human and financial resources.

• Experience in managing communications and high-level preparation of study related documentation.

• Experience conducting safety and efficacy studies.

• Experience handling confidentiallaboratoryand scientific data.

• Experience executing administrative strategies.

• Proven organizational skills and attention todetails.

• Demonstrated ability to communicate effectively orally and in writing.

• Demonstrated ability to work in a team environment and to meet timelines and budgets.

• Experience within a laboratory environment.

• Experience training staff.

• Well versed in Microsoft Office suite (Excel, Word, PowerPoint).

Knowledge

• Knowledge of the basic principles of biology,immunologyand chemistry.

• Knowledge of the principles of safe handling of potentially pathogenic substances and contaminated materials.

• Knowledge of CCAC and OMAFA regulations.

• Familiar with the following acts and regulations: ISO 17025 (2017), OECD Principles on GLP, CCAC guidelines and policies and the Animals for Research Act.

• Knowledge of occupational health and safety practices.

• Knowledge of the basic principles of scientific research.

• Knowledge and understanding ofTranspharmationCanada'sStandard Operating Procedures.

• Knowledge of computers, including word processing,spreadsheetsand databases.

• Knowledge of therapeutic development regulatory guidelines.

• Familiar withdevelopmentof new products for human and animal health care.

• Familiar with new methodologies and processes in relevantareaof specialization.

Disclaimer

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We are committed to fair, inclusive, and biasaware hiring practices and comply with Ontario legislation. If you require accommodation at any stage of the recruitment process, please let us know.