Hess Associates - Current Openings 711-170 The Donway West
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Biopharmaceutical Positions

2573B 2576N Laboratory Services Manager N ON 2568 Phase I Clinical Operations Director/Sr. Manager US Midwest 2567 CRO Phase I Bioanalytlical Lab Operations Director GTA 2564N HealthCare Related Sr. RDBMS Data Architect / Modeler USA 2551 Diagnostic Imaging FSE Specialist NYC 2528 GLP/GCP Immunoassay Development Leader GTA 2509N PhD Clinical Psychologist (Adults) f/t or p/t GTA 2490 Associate Director, Preclincal Toxicology Montreal 2456 Sr. GLP QA Auditor (Preclinical CRO) QC 2451 Sr. CRO Study Director Preclinical Toxicology Montreal

Job ID: 2573N
Position: 2573B 2576N Laboratory Services Manager N ON
Location: Owen Sound, ON
Description: Healthcare organization in Cottage Country, Owen Sound, ON is looking for a Laboratory Services Manager. RESPONSIBILITIES: - Lab operations - meeting accreditation, regulatory requirements, QMS, quality patient care services related to lab services. - Operations and HR budgets. - Audits, budget administration, resource allocations, capital purchases. - Staff - hiring, performance appraisals. - Good at working with Clinicians, other Managers re operational and patient care issues. - Helping to develop and implement emergency and disaster planning. REQUIREMENTS: - Bachelor of Medical Laboratory Science OR College Certificate in Medical Laboratory Technology. - CSMLS Certification. and registered with CMLTO. - Min 5 - 7 years of clinical experience. - Min 3 years' leadership experience in a medical laboratory setting. - Strong background in Chemistry, Hematology, Transfusion Medicine. - IQMH and regulatory requirements. - Excellent lab software, union, English communication, decision making skills. Apply


Job ID: 2568
Position: 2568 Phase I Clinical Operations Director/Sr. Manager US Midwest
Location: St. Louis , MO
Description: Phase I Clinical research organization CRO in the Greater St. Louis area is looking for a Clinical Facility Operations Director OR Senior Manager to oversee all aspects of the daily operation of the clinic facility, planning, organizing and overseeing clinical activities related to each study - clinical procedures, recruitment, and screening. This is a senior position for an experienced specialist. GCP adherent. ROLE AND RESPONSIBILITIES: - Operation of Phase I clinic facility on daily basis - study clinical procedures, recruitment, and screening volunteers - all under GCP. - Planning study arrangements with Project Management such as clinic scheduling and assignment, and dosing schedules, and assigning study and screening coordinators accordingly. - Ensuring that studies meet protocols, clinic operation and safety, realistic timelines. - Staff responsibility including training to avoid or correct errors. - Ensure that study schedule meets timelines by working together with other departments such as Quality, PK, Bioanalytical. - Supply chain, pharmacy, special client requests. REQUIREMENTS: BS/MS/PhD/Pharm degree - medically related background preferred. 7-10 years' Phase I CRO direct experience. SME on Phase I with the “on the floor” experience a must have. Experience working with other clinical departments including bioanalytical, PK, QA, CDM to ensure study is delivered on schedule. Hands-on familiarity with early phase clinical trials, study operations and documentation. Excellent interpersonal, organizational, computer, and English communication skills. Able to work alone or as a team player. Apply


Job ID: 2567
Position: 2567 CRO Phase I Bioanalytlical Lab Operations Director GTA
Location: Toronto, on
Description: Clinical research organization CRO in the Greater Toronto area is looking for a Phase I Lab Operations Director to oversee all aspects of laboratory operations and research and development. This is a senior position for an experienced specialist. Clinical phase - not preclinical. BA/BE, ADME focus. Focus on the bioanalytical side. ROLE AND RESPONSIBILITIES: - All clinical laboratory operations under GLP. - Equipment related to all bioanalytical analyses - bioequivalence, bioavailability, ADME. - SOPs, method development, validation, data integrity, regulatory. - Staff management, review, performance management. - Client interaction. - Contract management. - Health and safety. - Keeping lab totally up to date REQUIREMENTS: M.Sc. 12 years' working in a lab including if possible a bioanalytical lab. Background doing drug analyses in biological samples under GLP. BA/BE, ADME studies. Experience in a leadership role. Experience with all of the roles and responsibilities mentioned above. This is a key position in terms of having the company keep totally up to date in terms of bioanalytical services and development. Apply


Job ID: 2564N
Position: 2564N HealthCare Related Sr. RDBMS Data Architect / Modeler USA
Location: Minneapolis, MN
Description: Healthcare industry client in Minneapolis, MN, is looking for a Principal/Senior Data Modeler/Architect. Require true understanding of data in both relational and non-relational databases (noSQL, Big Data). Any background as a solutions architect excellent, noting that the role does focus on data modeling. ROLE AND REQUIREMENTS: - BS in Software, Electrical Engineering, Software Engineering, or related. - Hands-on Big data, NoSQL, DocDB and HBase experience. - Experience working in Azure and/or AWS clouds with SaaS. - Clinical infrastructure healthcare domain knowledge (IT Systems, HL7, EMR's, HIPAA). - Experience modeling data for operational and information/business intelligence solutions. - Need both relational and non-relational data background. - Should have transformed a data model from a relational database RDBMS to NoSQL (where the RDBMS supported a transactional system). - Ensure data integrity, high performance, reliability and scalability, plus security and privacy compliance. Company will do relocation to Minneapolis and visas. Position is on-site, not remote. MUST HAVES: NoSQL, Hbase, Azure or AWS Cloud, HL7 or Health care. Apply


Job ID: 2551
Position: 2551 Diagnostic Imaging FSE Specialist NYC
Location: New York, NY
Description: Prestigious Manhattan health care center is recruiting for a diagnostic medical imaging instrumentation repair specialist. ROLE AND RESPONSIBILITIES: Maintain, repair medical imaging equipment routinely used for heart, brain, other imaging, such as X-Ray, Fluoroscopy, MRI, CT, ultrasound, nuclear medicine. REQUIREMENTS: BS Electronics/B.Eng./BS Biomedical/ OR A.S. Degree in related field. 3 years doing biomedical instrumentation medical imaging equipment maintenance and repair. One year up-to-date, recent or current work. Focus on medical imaging modalities, not other types of hospital lab equipment such as analyzers, etc. any knowledge of PACS/RIS very helpful. Excellent English, organizational, interpersonal, team player skills. Apply


Job ID: 2528
Position: 2528 GLP/GCP Immunoassay Development Leader GTA
Location: Toronto, ON
Description: Drug development client in Toronto is looking for a GCP/GLP supervisor. You will oversee bioanalytical immunoassay method development as carried out by the CROs to which they outsource their drug testing requirements. Background required would be a combination of experience and leadership in both bioanalytical chemistry and immunoassay, immunogenicity, ligand binding methodologies. RESPONSIBILITIES: Project management and relationship building. Bioanalytical method development and supervision. RFPs, contributing to regulatory submissions. Communicating with global CRO’s virtually. Ensure that CROs follow SOPs and GLP. Devise method development training programs. This position requires 100% excellent English communication skills as it is very client-facing. REQUIREMENTS: B.Sc./ M.Sc. Life Sciences /related. GCP/GLP background. Experience in method development for bioanalytical/immuno assays. MUST have excellent English communication skills as this is a client facing position. 4 years' designing and/or managing clinical trials. Background managing large projects. Regulatory affairs. Multitasker, computer literate, independent and team player abilities. Apply


Job ID: 2509N
Position: 2509N PhD Clinical Psychologist (Adults) f/t or p/t GTA
Location: Toronto, ON
Description: A private global mental health organization is recruiting for a Clinical Psychologists (PhD) for their Mental Health Assessment Departments in Toronto, ON. Must have CBT experience, working with adults. Full or part time. ROLE: The Clinical Psychologist will have the opportunity to help further embed mental health with the Annual Health Assessment, and/or see clients for ongoing care in the private practice. KEY ACCOUNTABILITIES: Review and interpret client screening results and adapting an assessment in real time to reflect client profile and self -identified goals and needs Leverage evidence-based strategies such as Cognitive Behavioural Therapy, Positive Psychology and Motivational interviewing Assist in the development of a client action plan to address current or potential future obstacles and challenges, build on sustain resiliency and renew or improve performance Building strong relations with the Client's Annual Health Assessment team to coordinate care and enhance the client experience Prepare a summary report to reflect relevant client insights and action plans which may include referrals and resource recommendations. PRIVATE PRACTICE: Coordinate independent psychological assessments; providing diagnoses and recommendations for ongoing treatment as appropriate. Develop and communicate with client-centered treatment plans that meet both client goals and address the client's psychosocial and behavioural challenges. Provide empirically validated treatment measures; training and experience in Cognitive Behavioural Therapy required. Collaborate with the client's existing treatment team to coordinate care. Maintain documentation as required. RESPONSIBILITIES: Conducting independent psychological assessments of clients referred to the client from various referral sources. Providing a diagnosis and recommendations for further treatment as appropriate. Developing and communicating a treatment plant to the client, multidisciplinary team, other stakeholders and referral sources. Preparing documentation and formal narrative reports for the referral source. Providing treatment to client, enabling clients to reach their full functional and work re-integration potential in collaboration with clients, treatment teams and all stakeholders. QUALIFICATIONS; PhD in Clinical Psychology Current registration in good standing with the College of Psychologists of Ontario. CBT and short-term therapy training are essential. Minimum 3-5 years clinical experience with adults, preference working with executives. Declared competency in Health Psychology an asset for the population required. Background working with business executives of great interest. Apply


Job ID: 2490
Position: 2490 Associate Director, Preclincal Toxicology Montreal
Location: Montreal, QC
Description: POSITION: Associate Director, Toxicology with a rapidly growing preclinical GLP contract research organization (CRO) based in Montreal. LOCATION: Montreal, QC REPORTS TO: Toxicology Director ROLE AND RESPONSIBILITIES: - Supervising a number of Study Directors. - Undertake a SD role as required re non-clinical safety studies for key clients, large projects, and specialized study types. - Play a significant role in training of less experienced toxicologists. - Advise clients on study design and regulatory issues. - Take a leading role in in-house committees and task-forces, sales and marketing events. - Act as Toxicology Director re staff management, special projects, review of study plans and reports. - Expertise in a specific area of non-clinical safety assessment, as demonstrated by publications (e.g. abstracts, posters, papers), and/or invited lectures, etc. - Key person for training of staff, interacting with sponsors, and undertaking management responsibilities. REQUIREMENTS: Ph.D. in a relevant field, or B.Sc./M.Sc. with DABT Board Certification in Toxicology, or equivalent professional qualification. 5 years' as Senior Toxicologist, Study Director, Senior Research Scientist, or a suitable combination of toxicology -relevant scientific and technical experience. Small animal R&D, re PK, TK, ADME study experience. Require deep understanding of toxicology and regulatory issues - PK, TK, related, interpretation of study director reports. Excellent time management skills and attention to quality. Must be Canadian citizen or Canadian permanent resident, in Canada or able to return. Apply


Job ID: 2456
Position: 2456 Sr. GLP QA Auditor (Preclinical CRO) QC
Location: Montreal, QC
Description: Montreal CRO preclinical testing laboratory seeks a GLP QA Auditor to monitor studies, systems, data, and procedures to make sure that work is done in compliance with GLP. ROLE AND RESPONSIBILITIES: - Audit toxicology study plans, reports, raw data re completeness, accuracy and GLP compliance. - Investigate the critical phases of all preclinical studies re method validation, sample analysis for compliance with study plans, to ensure compliance with SOPs, GLP. - Attend an average of 4 necropsies procedures per month. - Write inspection reports, finalize reports and audit sub-contractors. - Communicate non-compliance to study personnel, directors, and management and recommend corrective action. - Audit facility/laboratory as required. - Make sure there are written and signed records of auditing activities. REQUIREMENTS: B.Sc. or DEC with several years working in a GLP unit. QA inspection/audit experience with respect to toxicology and related preclinical studies. Must be willing to attend necropsies. Excellent comprehension of Good Laboratory Regulations. Able to train others. Strong English and French communication skills. Detail oriented with excellent interpersonal, organizational, or team player skills. Apply


Job ID: 2451
Position: 2451 Sr. CRO Study Director Preclinical Toxicology Montreal
Location: Montreal, QC
Description: Montreal, QC preclinical testing laboratory seeks a Toxicology Study Director to be responsible for toxicological (GLP) investigation of pharmaceuticals. ROLE AND RESPONSIBILITIES: Designing protocols and programs. Overseeing all technical and scientific activities and in-life monitoring. Responsible for overall conduct of pre-clinical drug studies. Communicating with sponsors. Interaction with internal (QA, Bioanalytical) and external customer/s Writing reports, protocols, and evaluating data. Serving as the scientific representative on corporate committees. Attending scientific meetings. Training of junior technical and scientific personnel. Carry out R&D in line with company objectives. REQUIREMENTS: BSc. (min) plus 5 years as a Tox Study Director in the CRO, biotechnology, OR pharmaceutical industry. Experience with safety studies of biologics and drugs. Background in the review and tabulation of study data (PK analysis). Knowledge of ADME studies (Absorption, Distribution, Metabolism and Excretion). Able to provide quotes for new incoming studies. Excellent organizational, protocol and report writing skills, working knowledge of GLP, SOPs. Please note that this is GLP, not GMP or GCP. Hands-on, able to deal with the animal experimentation side of testing. French / English bilingual nice to have. Apply