EMPLOIS

Position: Associate Director/Director – Clinical Biomarker Lead

Company: Repare Therapeutics

Location: Cambridge, Massachusetts, USA

Website: http://www.reparerx.com/

Repare Therapeutics (Nasdaq: RPTX) is a leading precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics. The Company utilizes its genome-wide, CRISPR-enabled SNIPRx® platform to systematically discover and develop highly targeted cancer therapies focused on genomic instability, including DNA damage repair. The Company’s pipeline includes its lead product candidate RP-3500, a potential leading ATR inhibitor, as well as a CCNE1-SL inhibitor and Polθ inhibitor programs.

Repare is growing at a rapid pace with challenging and exciting opportunities for experienced professionals. We look for scientific and business professionals who are highly motivated, collaborative and, above all, share our passionate interest in fighting cancer and improving patients’ lives.

We are seeking a Clinical Biomarker Lead that will be accountable for delivery of robust, scientifically driven biomarkers in drug development programs for synthetic lethal drug targets in oncology. This individual will have the opportunity to impact an industry-leading portfolio of Synthetic Lethal Drug Programs from inception of drug candidate and throughout clinical development.

RESPONSIBILITIES

• Identify, develop and implement cutting edge science and technological advances into biomarker and companion diagnostic (CDx) strategies to guide indication selection, patient enrichment, and combination strategies.
• Develop translational analysis plan and ensure its seamless incorporation into clinical study design and alignment with clinical study objectives. Measure target engagement reliably and quantifiably to inform clinical decisions for selecting therapeutically relevant doses and schedules.
• Clinical Biomarker Lead for multiple phase clinical trials ranging phase I-II.
• Understand key cancer pathway interactions and feedback mechanisms in clinical samples to guide rational drug combinations.
• Define novel mechanisms of resistance targeted therapies by studying tumors at relapse
• Provide input to clinical teams on biomarker-related elements of study trial design and conduct and incorporating biomarkers into clinical protocols, lab manuals and consent forms
• Provide scientific expertise and technical guidance to enable timely biomarker sample collection.
• Execute sample testing plan and deliver high quality biomarker data packages to inform clinical development and regulatory strategy. Point contact for resolving study biomarker issues.
• Manage effective working relationships with clinical operations, clinical science, biology leads, bioinformatics and regulatory functions.
• Establish and manage external collaborations with leading academic groups, diagnostic partners, and CROs.
• Contribute to scientific credibility of company through contributions to the scientific literature (publications/presentations).

QUALIFICATIONS

• PhD. in a life scientific discipline
• 5-8 years in biotechnology, pharmaceutical industry or clinical setting in the application of biomarkers in clinical trials preferably in oncology biomarker development.
• Extensive experience in the development of clinical biomarkers with a proven track record of success.
• Highly experienced in oncology translational research on molecularly targeted therapies, with proven track record of high-impact contributions to biomarker discovery and/or assay development.
• Experience in conducting clinical trials, conducting biomarker analyses on various clinical sample types and working as part of a clinical study team.
• Up to date knowledge and deep understanding of major molecular and genomic assay technologies and platforms. Engaging
• Experience with developing and validating fit for purpose clinical assays
• Having a strong sense of urgency and excellent skills in prioritization, planning as well as timely execution in a very fast-paced environment.
• Strong interpersonal skills and ability to thrive in a matrix environment.
• Experience in managing research collaborations, contract laboratories and budgets.
• Dependable and trustworthy, willing to take ownership and responsibility

Position: Associate Director/Director, Clinical Scientist

Company: Repare Therapeutics

Location: Cambridge, Massachusetts, USA

Website: http://www.reparerx.com/

Repare Therapeutics (Nasdaq: RPTX) is a leading precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics. The Company utilizes its genome-wide, CRISPR-enabled SNIPRx® platform to systematically discover and develop highly targeted cancer therapies focused on genomic instability, including DNA damage repair. The Company’s pipeline includes its lead product candidate RP-3500, a potential leading ATR inhibitor, as well as a CCNE1-SL inhibitor and Polθ inhibitor programs.

Repare is growing at a rapid pace with challenging and exciting opportunities for experienced professionals. We look for scientific and business professionals who are highly motivated, collaborative and, above all, share our passionate interest in fighting cancer and improving patients’ lives.

We are seeking a Clinical Scientist, Associate Director/Director, to play a pivotal role in supporting key oncology programs. This position will report to the Head of Clinical Sciences. The Clinical Scientist will be responsible for providing scientific support for all clinical development activities. If desired the Clinical Scientist may also share or gain experience in our diagnostics development. This role offers a unique opportunity to progress your career by working on novel therapies in the DNA repair field, novel clinical trial designs and innovative approaches to global oncology drug development.

RESPONSIBILITIES

• Contribute to the development of clinical strategies and trial execution
• Perform ongoing review and analysis of study safety and efficacy data
• Provide support as needed for scientific issues that may arise during study execution
• Collaborate with the Clinical Operations group to develop consistent language and criteria for the Informed Consent Form (ICF), protocol eligibility, protocol safety, Case Report Forms (CRFs), etc.
• Collaborate with the Regulatory group Drafting of clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports, CSRs and other FDA submissions, including scientific advice, IND, EoP2, pre-NDA/BLA meetings, NDA/BLA and MAA documents
• Develop relationships with appropriate consultants
• Understand the asset’s biological mechanism, clinical strategy, scientific interpretation of disease and target-based literature
• Understand and support creation of competitor landscape, medical need, regulatory strategy
• Perform literature searches and summarize the relevant scientific, drug development and medical literature to support document development, such as the investigator brochure, protocol design, clinical study report, competitive assessments, etc.
• Provide scientific/medical supportive materials to in-house staff and external consultants in the indications being studied
• Write abstracts and present data at scientific meetings, both internally and externally.
• Contribute positively to a strong culture of business integrity and ethics
• Act within compliance and legal requirements as well as within company guidelines

BASIC QUALIFICATIONS

• Bachelor’s degree in life sciences or related discipline (at minimum)

PREFERRED QUALIFICATIONS

• Advanced degree (e.g. MS, PhD, PharmD)
• Minimum of 3 years of experience in a pharmaceutical industry or CRO environment in drug development
• Prior Oncology Drug Development experience is required.
• Experience in developing and writing study protocols, study procedures manuals, informed consent forms and clinical study reports.
• Proven track record of working with investigators, site staff, external experts, Contract Research Organizations and vendors
• Demonstrated ability to work in matrix teams and in a fast-paced environment.
• Excellent management, communication and organizational skills required with demonstrated success in leading projects and interacting with cross functional teams
• Strong Analytical ability.
• Excellent interpersonal and decision-making skills.
• Ability to work independently and enthusiasm to deliver the program objectives in a timely manner. Negotiation and influential skills are advantageous.
• Demonstrated ability to comprehend complex scientific concepts and data. Proficient in reviewing and assessing clinical data.

Position: Document Control Specialist/Manager

Company: Repare Therapeutics

Location: Cambridge, Massachusetts, USA

Website: http://www.reparerx.com/

Repare Therapeutics (Nasdaq: RPTX) is a leading precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics. The Company utilizes its genome-wide, CRISPR-enabled SNIPRx® platform to systematically discover and develop highly targeted cancer therapies focused on genomic instability, including DNA damage repair. The Company’s pipeline includes its lead product candidate RP-3500, a potential leading ATR inhibitor, as well as a CCNE1-SL inhibitor and Polθ inhibitor programs.

Repare is growing at a rapid pace with challenging and exciting opportunities for experienced professionals. We look for scientific and business professionals who are highly motivated, collaborative and, above all, share our passionate interest in fighting cancer and improving patients’ lives.

Repare Therapeutics is looking for a Document Control Specialist or Manager whose primary responsibility is coordinating Document Control and activities related to the identification, collection, distribution and filing of controlled documents in an FDA regulated environment.  This position supports critical documentation within cross-functional teams and will ensure the integrity of document creation, version control, storage, retrieval, and lifecycle management are effectively implemented.  This position will aid in ensuring that document management is consistent across the organization, while maintaining control and traceability of the documentation history in compliance with GxP regulations.  Key contributions of the role will include writing, revising, and maintaining document control procedures as well as participation in the development and deployment of document control tools.

RESPONSIBILITIES

• Independently manage and monitor the processing, review, and approval of all controlled documents in both electronic document management systems (DMS) and supporting manual systems
• Coordinate the revision process of Standard Operating Procedures (SOPs), forms, and other controlled documents assuring that the corporate and regulatory standards are upheld
• Manage the daily flow and final release of controlled documents through the document management system.
• Continuous improvement of the Document Control program
• Participates in the development and roll-out of document control tools, monitors documentation/Quality Systems function, and coordinates with IT on issues
• Provide user assistance and training on the DMS
• Develops and delivers training regarding document control processes and system changes
• Ensure compliance with controlled document format and content
• Maintain master documents and records (both hardcopy and/or electronic) to ensure documentation is retrievable and files are accurate, complete, and well organized
• Manage the document periodic review process
• Responsible for managing record retention policies and procedures
• Track and communicate company training compliance within multiple departments
• Assist with the development of evolving document control systems
• Maintain SOP, change control, deviation, CAPA, etc. logs contemporaneously
• Assist with generating Quality Document Control metrics as needed
• Represent quality in departmental or team meetings
• Assist Quality Management by performing various tasks in support of the administration and maintenance of Quality Systems
• Represent Quality Assurance as the Subject Matter Expert (SME) for Good Documentation Practices

QUALIFICATIONS

• Bachelor’s degree, Life Sciences preferred, but now required
• Experience in Document Control System and network-based Quality Management Systems
• Worked in an FDA regulated environment
• Minimum of two (2) years QA document control experience
• Proficient in document management systems
• Highly Proficient in Word, Excel, and PowerPoint – Smartsheet and SharePoint are a plus
• Familiar with FDA regulations
• Ability to work effectively on multiple projects simultaneously with minimum supervision
• Strong interpersonal and communication skills
• Able to organize and prioritize work
• Strong written and verbal communication skills
• Effective/concise communicator with management and internal teams
• Experience with working in startup environments moving in rapid growth/manufacturing

Position: Principal Bioinformatician

Company: Repare Therapeutics

Location: Cambridge, Massachusetts, USA

Website: http://www.reparerx.com/

Repare Therapeutics (Nasdaq: RPTX) is a leading precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics. The Company utilizes its genome-wide, CRISPR-enabled SNIPRx® platform to systematically discover and develop highly targeted cancer therapies focused on genomic instability, including DNA damage repair. The Company’s pipeline includes its lead product candidate RP-3500, a potential leading ATR inhibitor, as well as a CCNE1-SL inhibitor and Polθ inhibitor programs.

Repare is growing at a rapid pace with challenging and exciting opportunities for experienced professionals. We look for scientific and business professionals who are highly motivated, collaborative and, above all, share our passionate interest in fighting cancer and improving patients’ lives.

We are seeking a Principal Bioinformatician with the passion and desire to become part of a fast-based, innovative team committed to developing breakthrough cancer therapies. The individual will be a self-starter that is effective in working independently as well as a collaborative team member. The successful candidate will help define and implement bioinformatics strategy and mentor junior team members. They will collaborate with members of our SNIPRx® platform team to identify novel synthetic-lethal targets. Furthermore, they will collaborate with translational scientists to help identify patient populations where our drugs are efficacious and effectively lead them into the clinic.

Responsibilities:

• Act as an internal thought leader on data analysis for target discovery and translational efforts
• Mentor junior bioinformatics team members in target discovery, translational bioinformatics, or cancer genomics
• Implement and improve analytical approaches for target and biomarker identification
• Collaborate with and support target discovery and translational teams by helping design experiments and analyze genomic datasets
• Collaborate with internal and external teams to develop and implement a state-of-the-art computational analysis platform for omics-based oncology drug discovery
• Apply and develop computational, statistical, and machine learning methods to mine multi-dimensional genome-scale data sets and derive biological insights
• Execute integrative analysis of cancer omics, clinical information and functional genomic data to support prioritization of targets and stratification of patients
• In collaboration with discovery and translational science teams, propose testable hypotheses and experimental verification plans to support program decisions

Qualifications:

• PhD in Bioinformatics, Computational Biology, System Biology, or related fields
• Work experience
  • Four (4) years or more of bioinformatics research experience in the biotech or pharmaceutical industry, or
  • Six (6) years or more of post-doctoral academic bioinformatics experience in oncology target discovery, oncology translational sciences, or oncology medical genomics
• Desired scientific experience
  • Cancer biology and cancer genomics. Experience with DNA Damage and Repair pathways is desirable.
  • Analysis of large cell line panel data such as CRISPR-Cas9 knockout screens and barcoded drug treatment screens (e.g. PRISM)
  • Familiarity with large genomic datasets such as the Cancer Dependency Map, The Cancer Genome Atlas, Genotype-Tissue Expression (GTEx)
• Experience working closely with biology teams to design and analyze experiments.
• Strong hands-on programing skills (R, Python, Unix, SQL, etc)
• Solid understanding of probability and statistics.
• Management experience highly desirable
• Collaborative team player who is also an independent thinker; ability to develop a strong point of view combined with the openness to evolving that view based on new data and analysis
• Ability to handle multiple projects and utilize judgement to prioritize tasks

Position: Coordinator, Clinical Biomarker Operations (CBO)

Company: Repare Therapeutics

Location: Cambridge, Massachusetts, USA

Website: http://www.reparerx.com/

Repare Therapeutics (Nasdaq: RPTX) is a leading precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics. The Company utilizes its genome-wide, CRISPR-enabled SNIPRx® platform to systematically discover and develop highly targeted cancer therapies focused on genomic instability, including DNA damage repair. The Company’s pipeline includes its lead product candidate RP-3500, a potential leading ATR inhibitor, as well as a CCNE1-SL inhibitor and Polθ inhibitor programs.

Repare is growing at a rapid pace with challenging and exciting opportunities for experienced professionals. We look for scientific and business professionals who are highly motivated, collaborative and, above all, share our passionate interest in fighting cancer and improving patients’ lives.

We are seeking a Coordinator, CBO with the passion and desire to become part of a fast-based, innovative team committed to developing breakthrough cancer therapies. This individual will coordinate with translational researchers, clinical operations and PK team members in order to implement and maintain biomarker and clinical sample operational plans. This position requires a combination of scientific and project management expertise as they will be responsible for the support of clinical laboratory functions within clinical trials; Includes operational support for biomarker definition and selection, clinical testing schedules, and lab manual creation.

Responsibilities:

• Manage end-to-end sample tracking and logistics for clinical samples, working closely with the central and specialty lab vendors as well as a sample and data management vendor
• Identify, triage, and resolve biomarker sample queries to ensure sample and data integrity
• Monitor trends and quality metrics as they relate to clinical site sample collection, processing and shipment errors
• Ensure biomarker laboratory documents are filed appropriately in the eTMF
• Maintain biomarker documentation (requisition forms, analysis request forms, redacted patient files, etc.) in an organized manner
• Assist with creating site and team training tools as they relate to clinical biomarker operations
• Liaise with the preclinical teams to help drive translational research projects and ensure timely data delivery

Qualifications:

• Bachelor’s degree with Science focus
• Experience managing clinical labs study startup and oversight
• 1-3 years experience in clinical operations with a focus on clinical laboratory management
• Strong verbal and written communication skills
• Excellent interpersonal and organizational skills
• Ability to deal with competing priorities
• Strong reasoning, detail orientation and problem-solving abilities are essential
• Ability to work on teams and on multiple concurrent projects, and works well under general direction with tight timelines

POSITION DESCRIPTION

Position: Associate Director/Director of Quantitative Pharmacology

Company: Repare Therapeutics

Location: Cambridge, MA, USA / Remote

Website: http://www.reparerx.com/

Repare Therapeutics (Nasdaq: RPTX) is a leading precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics. The Company utilizes its genome-wide, CRISPR-enabled SNIPRx® platform to systematically discover and develop highly targeted cancer therapies focused on genomic instability, including DNA damage repair. The Company’s pipeline includes its lead product candidate RP-3500, a potential leading ATR inhibitor, as well as a CCNE1-SL inhibitor and Polθ inhibitor programs.

Repare is growing at a rapid pace with challenging and exciting opportunities for experienced professionals. We look for scientific and business professionals who are highly motivated, collaborative and, above all, share our passionate interest in fighting cancer and improving patients’ lives.

The Associate Director/Director of Quantitative Pharmacology reports to the Head of Nonclinical Development and serves as an integral contributor to all the preclinical and clinical development projects at Repare.

KEY RESPONSIBILITIES

• Partner with Head of Nonclinical Development, Program Team leaders and R&D staff to lead the pharmacometrics and quantitative PK/PD strategy for Repare’s discovery and development programs
• As a member of the Repare’s project teams, the individual will be responsible for applying model-based approaches to support compartmental and mechanism-based PK/PD analysis, evaluation of FIH dose and regimen recommendations.
• Develop and execute strategies for mid-stage and late-stage Oncology programs to support regulatory questions and filings
• Provide due-diligence and strategic regulatory advice/evaluations for oncology drug development programs
• The successful incumbent will utilize a range of computational approaches (PK/PD, PBPK, pharmacometrics, systems-based, informatics). The scope of project responsibility will range from late discovery through registration.

QUALIFICATIONS

• A Ph.D. in Pharmacology, Biology, Engineering, Mathematics or related field with 5+ years of relevant experience in modeling and simulation.
• Excellent understanding of PK (NCA, compartmental) and PK/PD principles.
• Expertise in the application of Phoenix WinNonlin, PBPK related software, and R is required.
• Experience with PopPK model development with regulatory reporting is a plus.
• Superior communication skills (both written and oral) and attention to detail
• Strong organizational skills
• Leads by example and highly collaborative with the proven ability to work in a cross-functional internal and external teams
• Must be able to prioritize work effectively to ensure progression of multiple department and corporate timelines
• Pro-active in identifying opportunities along with strong problem solving and negotiation skills
• A strategic thinker who can generate ideas and opportunities and turn them into successful results

POSITION DESCRIPTION

Position: Chercheur scientifique – Enzymologie

Société : Repare Therapeutics

Endroit : Montréal, Québec, Canada

Site Web : http://www.reparerx.com/

Repare Therapeutics (Nasdaq: RPTX) est un chef de file de l’oncologie de précision grâce à son approche exclusive de la létalité synthétique qui lui permet de découvrir et de développer de nouveaux produits thérapeutiques. La Société utilise sa plateforme SNIPRx® pangénomique, basée sur les technologies de criblage létales synthétiques CRISPR pour découvrir et développer méthodiquement des thérapies anticancéreuses hautement ciblées, tirant avantage de l’instabilité génomique et de la réparation de l’ADN endommagé. Les projets de développement de la Société comprennent le produit candidat principal RP-3500, un inhibiteur potentiel de l’ATR, une thérapie ciblée de létalité synthétique pour une cible CCNE1 non divulguée et le programme Polθ.

Repare connaît une croissance rapide et ponctuée de défis et d’occasions excitantes pour les professionnels d’expérience. Nous sommes à la recherche de professionnels dans les domaines des sciences et des affaires qui sont très motivés, prêts à collaborer et, par-dessus tout, qui partagent notre passion et notre intérêt à lutter contre le cancer et à améliorer la vie des patients.

Repare Therapeutics est à la recherche d’un chercheur scientifique à l’esprit d’équipe et très motivé qui viendra s’ajouter à notre service de biologie afin de favoriser l’avancement de notre portefeuille de thérapies létales synthétiques (LS) contre le cancer. Le candidat devrait posséder une vaste connaissance de l’enzymologie, de la mise au point/optimisation d’essais, ainsi que des techniques dans le domaine de la biochimie. Ce scientifique devrait contribuer par son expertise à la conception d’essais biochimiques et être en mesure de mener des expériences axées sur la caractérisation biophysique des composés tête de série en appui aux activités de lead ID/Opt. Le candidat choisi dirigera une partie du programme de découverte de médicaments et surveillera les capacités d’exécution des essais (internes et imparties). Une expertise dans la culture cellulaire est un atout. Les candidats doivent être capables de communiquer clairement, de collaborer et de profiter d’un cadre de recherche dynamique et pratique.

RESPONSABILITÉS

• Procéder à des analyses cinétiques des enzymes et à des études des protocoles d’entente afin de caractériser les différents systèmes d’enzymes biologiques, incluant les kinases, les polymérases et les différents enzymes de réparation de l’ADN.
• Concevoir et élaborer des essais sur microplaques biochimiques à débit de moyen à élevé (c’est-à-dire de type enzymatique, avec liaison) pour identifier et caractériser les modulateurs de petites molécules en ayant recours à différentes techniques et méthodes de détection, incluant FP, FRET, TR-FRET, BRET, HRTF, ainsi que des méthodes par spectrométrie de masse, chromogénie, luminescence et radiométrie.
• Appliquer différentes techniques biochimiques et biophysiques afin de caractériser l’interaction moléculaire des petites molécules nouvelles avec leurs protéines cibles, incluant les essais de liaison radiomarquée, l’essai de polarisation par fluorescence, la fluorimétrie d’analyse différentielle (ou essai de variation thermique), la résonance plasmonique de surface (RPS/Biacore), ainsi que la calorimétrie à titrage isotherme (CTI).
• Élaborer des essais à partir de composants purifiés et de systèmes cellulaires configurés dans le but d’identifier des modulateurs à petites molécules authentiques et prédire leur activité in vivo.
• Collaborer de près avec les équipes de projet et les ORC de l’extérieur afin de déployer des essais biochimiques pour le criblage à haut débit et favoriser l’élaboration de relations structure-activité.
• Surveiller l’impartition des activités de production de protéines recombinantes et de développement d’essai à des ORC de l’extérieur et surveiller les résultats.
• Exécuter les expériences rapidement, de manière efficace et indépendante.
• Effectuer des présentations claires et succinctes dans différents environnements internes.
• Aptitudes marquées pour l’organisation et la gestion du temps, incluant la capacité de gérer plusieurs projets simultanément.
• Excellente approche pour le travail d’équipe – le travail se déroule au sein d’une équipe multifonctionnelle incluant des biologistes, des chimistes des médicaments, ainsi que des biologistes structuraux.

COMPÉTENCES

• Doctorat ou maîtrise en biochimie ou dans une discipline connexe assorti d’antécédents marqués dans le domaine de la cinétique enzymatique. Une expérience dans l’industrie biopharmaceutique est grandement préférée.
• Une connaissance avancée et des antécédents dont il est possible de faire la preuve en enzymologie et dans l’étude des mécanismes d’action des inhibiteurs d’enzymes.
• Aptitude pour l’analyse des données et l’interprétation des différents modèles dans le domaine de la cinétique enzymatique.
• Connaissance des méthodes biophysiques aux fins de l’étude des enzymes (par exemple, spectrométrie UV/VIS/de fluorescence, spectrométrie de masse, polarisation de fluorescence).
• Une expérience dans l’industrie en matière de développement d’essais fiables sur les enzymes pour soutenir les efforts de séquençage à haut débit ou de chimie médicinale, incluant des antécédents reluisants dans le domaine de la progression des composés constitue un atout.
• Aptitudes pour l’analyse des données et la production de rapports (IC50, EC50, évaluation de la variabilité des essais, etc.).
• Bonne compréhension des systèmes d’expression et de purification des protéines.
• Expérience d’un logiciel pertinent pour la recherche en laboratoire et l’interprétation des données.
• Aptitudes marquées pour la communication orale et écrite.
• Capacité d’évoluer dans un environnement dynamique et en équipe.

Position: Clinical Trial Manager/Senior Clinical Trial Manager

Company: Repare Therapeutics

Location: Cambridge, Massachusetts, USA

Website: http://www.reparerx.com/

Repare Therapeutics (Nasdaq: RPTX) is a leading precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics. The Company utilizes its genome-wide, CRISPR-enabled SNIPRx® platform to systematically discover and develop highly targeted cancer therapies focused on genomic instability, including DNA damage repair. The Company’s pipeline includes its lead product candidate RP-3500, a potential leading ATR inhibitor, as well as a CCNE1-SL inhibitor and Polθ inhibitor programs.

Repare is growing at a rapid pace with challenging and exciting opportunities for experienced professionals. We look for scientific and business professionals who are highly motivated, collaborative and, above all, share our passionate interest in fighting cancer and improving patients’ lives.

We are seeking a Clinical Trial Manager/Senior Clinical Trial Manager with the passion and desire to become part of a fast-based, innovative team committed to developing breakthrough cancer therapies. The individual will be a self-starter that is effective in working independently as well as a collaborative team member. The successful candidate will ensure the Company’s clinical trial(s), in support of its innovative clinical pipeline, are managed to the highest quality to ensure safety and effectiveness of products in adherence with all applicable regulations.

RESPONSIBILITIES

• Leads cross-functional trial team to ensure delivery of complex clinical trials and manages protocol execution.
• Oversees CROs and vendors to ensure timelines, goals and deliverables are met with quality, within budget, and in accordance with SOPs, GCP and all applicable laws and regulations.

• Provides input to the clinical development plan and operational aspects of the clinical trial protocol (e.g., develops and/or reviews operational plans for trials).
• Prepares/reviews site study documents (i.e., site-specific informed consent, study tools/worksheets, investigator contracts, and site payments).
• Identifies and/or anticipates operational risks and mitigation plans within assigned clinical trials and escalates issues and recommends contingency plans to Head of Clinical Operations as necessary.
• Establish study milestones and ensure accurate tracking and reporting of study metrics, timelines, update of trial information in all trial databases and tracking systems.
• Provide monitoring oversight including authoring of oversight plan, reviewing monitoring visit reports and perform periodic oversight visits to sites and/or vendors to assess progress and compliance.
• Manage clinical trial budgets, providing ongoing financial reporting and projections to the finance group and facilitate the development of clinical trial agreements, insurance and other relevant documents in conjunction with legal.
• Ensure the Trial Master File (TMF) is maintained throughout the trial and performs inspection readiness checks throughout the lifecycle of the trial.
• Serves as functional area reviewer of global clinical / regulatory submissions.
• Present study status reports of operational execution activities to senior management.
• Provide study specific mentor and training for in-house Clinical Research Associate(s).
• Participates in operational process improvement initiatives (including, training, SOP review and development of work instructions/tools/templates).
• Performs other duties as assigned

QUALIFICATIONS

• Bachelor’s degree in a life science or a health-related field is preferred, Advanced degree highly preferred
• Five (5) years or more of progressive clinical management experience with the biotech / pharmaceutical industry or in a clinical research organization (oncology experience highly preferred), global trial experience highly preferred
• Solid understanding of the clinical trial database life cycle including, data collection, review and analysis, CRF design, database development and testing, discrepancy management, data quality review and database close and lock procedures
• Strong understanding of FDA/ICH guidelines and industry standard practices regarding clinical trial management
• Excels in a fast-paced, high-growth company environment with minimal direction and a high-degree of independence and able to adjust workload based on changing priorities
• Collaborative team player who is also an independent thinker; ability to develop a strong point of view combined with the openness to evolving that view based on new data and analysis
• Excellent communication skills. Ability to communicate in an open, clear, timely and consistent manner
• Ability to handle multiple projects and utilize judgement to prioritize tasks
• Ability to contribute as a team member in a dynamic, fast-paced biotech environment

DESCRIPTION DE POSTE

Poste : Spécialiste du soutien en matière de technologie de l’information

Compagnie : Repare Therapeutics Inc.

Emplacement : Montréal, Québec, Canada

Site Web : http://www.reparerx.com/

Repare Therapeutics (Nasdaq : RPTX) Repare Therapeutics est un chef de file parmi les compagnies d’oncologie de précision, grâce à son approche exclusive en matière de létalité synthétique lui permettant de découvrir et d’élaborer de nouveaux agents thérapeutiques. La compagnie utilise sa plateforme SNIPRx, pangénomique et compatible avec CRISPR, pour systématiquement découvrir et développer des thérapies anticancéreuses hautement ciblées axées sur l’instabilité génomique, notamment la réparation des dommages à l’ADN. La gamme de produits de la compagnie comprend le RP-3500, son leader au chapitre des produits candidats, un inhibiteur potentiel d’ATR d’avant-garde, ainsi que les programmes d’inhibiteurs CCNE1-SL et Polθ.

Repare croît à grande vitesse et offre des expériences stimulantes et excitantes aux professionnels chevronnés. Nous sommes à la recherche de scientifiques et de professionnels dans le domaine des affaires faisant preuve d’énormément de motivation, possédant un esprit de coopération et, par-dessus tout, partageant notre passion pour la lutte contre le cancer et pour l’amélioration de la vie de nos patients.

Le spécialiste du soutien en matière de technologies de l’information relève du responsable des technologies de l’information (TI) en tant que contributeur intégral au service de soutien technique offert aux systèmes d’opération ainsi qu’aux utilisateurs de Repare.

RESPONSABILITÉS PRINCIPALES

• Configurer, déployer, maintenir et gérer les appareils des utilisateurs (ordinateurs, portables et téléphones cellulaires) ainsi que les applications et les services requis pour utiliser adéquatement ces appareils
• Offrir aux utilisateurs un soutien technique rapide et excellent sur place ou à distance
• Maintenir l’application de l’assistance-client pour créer une base de données sur les services de soutien
• Surveiller et gérer les données sur la capacité et le rendement pour assurer le fonctionnement optimal des systèmes et des appareils de l’entreprise
• Sensibiliser les membres du personnel de Repare sur les risques en matière de cybersécurité et assurer qu’ils comprennent et adhèrent aux politiques et procédures de sécurité des systèmes
• Réviser les journaux de sauvegarde du système et contribuer au développement, à l’implantation, à la maintenance et à l’optimisation des pratiques de sauvegarde informatique et de reprise après sinistre de Repare
• Aider dans l’implantation et la maintenance des logiciels d’exécution des TI
• Participer au développement de la documentation sur les TI (processus et PNE)
• Contribuer à divers projets de TI en cours lorsque demandé

COMPÉTENCES

• Un baccalauréat en technologies de l’information ou un équivalent
• De l’expérience en gestion de système sur les plateformes suivantes : Microsoft Windows, Apple MacOS, Active Directory, IOS et Android
• De profondes connaissances de Microsoft Office 365 et de la gamme de produits Office en général
• De l’expérience pratique en soutien et en gestion de plateformes Microsoft SharePoint
• De très bonnes compétences en recherche d’anomalies dans le matériel informatique et les programmes d’ordinateurs et de portables, démontrant ainsi une habileté à résoudre rapidement des problèmes complexes ou à proposer une autre solution
• Une excellente aptitude à communiquer et à travailler avec une équipe en pleine expansion
• Des connaissances avancées des pratiques de sécurité du réseau et de ses normes
• Doit être capable de soulever (occasionnellement) de l’équipement ou du matériel pouvant peser jusqu’à 30 lb
• Une facilité à effectuer plusieurs tâches simultanément
• Une ouverture à travailler sur appel hors des heures de travail sur un base régulière
• Une ouverture à travailler hors des heures de travail si nécessaire
• Une excellente maîtrise du français et de l’anglais à l’oral ainsi qu’à l’écrit
• Les connaissances en gestion de données maîtres et en machines virtuelles sont un atout