Viela Bio

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Working at Viela Open Positions

Interested in a career with us? Check out our current open positions to find one that aligns with your expertise and passion. If you don’t see a role that fits your profile, then you can apply with our General Application.

  • Summary of Position

    Viela Bio is looking for a talented and highly motivated Manager/Sr. Manager of Clinical Operations. This is a position requiring solid understanding of all aspects of industry sponsored clinical trials Phases 1/2. Individuals suited for this position are highly independent, organized, dedicated to their programs and motivated by achieving organizational goals. Viela Bio is a fast-paced bio-technology company created to push the boundaries of science and clinical development in pursuit of life changing treatments for patients with rare diseases.

    Key Responsibilities
    • Provide matrix management of functional area representatives to cross-functional teams
    • Lead/oversee cross-functional CTTs for early phase studies
    • Define and manage accountabilities for all CTT members
    • Collaborate with cross-functional area heads to ensure proper resourcing for assigned trials
    • Support development of Protocol Concept Sheet (PCS) and Clinical Study Protocol (CSP)
    • Develop outsourcing specs for vendor requests for proposal and scope of work agreements
    • Manage selection of study vendors for assigned studies
    • Manage the vendor(s) throughout the life of assigned clinical trial
    • Provide input on investigational site selection in collaboration with Clinical Development and vendors
    • Review and refine Clinical Operations Plans/Vendor Oversight Plans
    • Provide oversight of monitoring activities through review of monitoring reports, QA-GCP audit reports and communications with investigators, study site personnel and CRAs
    • Lead ongoing review of data to ensure quality and consistency
    • Participate in planning and conduct of investigator meetings and ad boards, etc.
    • Develops and manage program budget(s) and oversees site agreement/budget negotiation process, and manage program timelines
    • Oversee the submission of trial-related and essential documents to the Trial Master File
    • Identify and provide solutions to clinical trial issues or risks
    • Provide input into non-project related activities and development of procedures/SOPs
    • Facilitate training to clinical study teams on protocol specific topics
    • Participate as appropriate in internal and external audits
    Desired Skills & Experience
    • Thorough understanding of country level regulations, ICH and GCP guidelines
    • Understanding of cross-functional clinical processes including data management, biostatistics, medical writing, drug safety, CMC and regulatory affairs
    • Ability to lead a cross-functional team in a matrix environment
    • Strong interpersonal, verbal, written communication and negotiation skills
    • Proven complex problem solving and decision-making skills
    • Ability to travel occasionally (internationally and domestically)
    • Minimum of 6 years progressive experience in clinical operations including 3 years of clinical project management or equivalent
    Education & Minimal Requirement

    BS preferred

    Please click HERE to submit your resume and cover letter. (Make sure to click Upload button on bottom left after your file selections)

  • Summary of Position

    Viela Bio is looking for a talented and highly motivated Director/Senior Director, Business Development. As part of the Business Development (BD) and Operations team, this individual will be responsible for supporting structuring, negotiating and executing a range of business development and corporate transactions, including collaborations, licenses, partnerships and other agreements. These are all aimed at helping Viela Bio develop achieve its corporate, scientific, portfolio, strategic and operational objectives. This individual will report to the Head of Business Development and Operations.

    Key Responsibilities
    • Contributing to and communicating business development strategy, progress and key issues to various stakeholder audiences in a concise manner.
    • Implementing business and corporate development strategies and supporting/leading transactions.
    • Soliciting internal feedback on deal issues and ensuring feedback is incorporated into deal documents in a manner that addresses Viela Bio’s business needs.
    • Actively tracking issues in deal documents, developing thoughtful solutions and assisting and/or leading in the negotiating of these issues.
    • Helping to develop negotiation strategy and leading or supporting counterparty negotiations.
    • Preparing supporting documentation for transactions (including external presentations, opportunity reports, management presentations and other deal communication materials).
    • Develop and maintain business relationships with key external collaborators in the academic, research, biotechnology, pharmaceutical and venture communities.
    • Working with the other part of team to identify and evaluate potential opportunities and providing guidance on deal-related communications/aspects of the early outreach phase.
    • Supporting due diligence efforts by managing workstreams and reviewing relevant counterparty materials.
    • Ad hoc supports to or lead of other business development and operation initiatives/tasks as needed.
    • Travel required.
    Desired Skills & Experience
    • 10+ years business development experience, preferably in biotech; deal sheet record demonstrating experience and specific roles, with hands on experiences supporting/leading transactions.
    • Advanced degree required.
    • In-depth knowledge of the drug research and development process and the regulatory, reimbursement and commercial environments.
    • Ability to simplify complex ideas/concepts and synthesize and summarize a complex set of facts.
    • Ability to develop creative solutions to complex problems.
    • Adept at handling multiple projects and tight deadlines in a fast-paced environment while maintaining attention to detail.
    • Comfortable reading, understanding and manipulating complex legal agreements.
    • Ability to work cross-functionally within and beyond the BD organization: experience working with both internal and external multidisciplinary teams including R&D, Commercial, Legal, IP, Finance and Operations.
    • Excellent written and verbal communication skills and ability to “think on your feet”.
    • High emotional intelligence and ability to forge relationships internally, as well as externally.
    • Able to excel in a very fast-paced and changing environment.
    • A desire to be part of a highly innovative company aimed at transforming the lives of people with serious inflammatory and autoimmune diseases.
    Education & Minimal Requirement

    PhD in science or MBA preferred.

    Please click HERE to submit your resume and cover letter. (Make sure to click Upload button on bottom left after your file selections)

  • Summary of Position

    Viela Bio is looking for a talented and highly motivated Director/Sr. Director, Global Program Development Lead (GPL). This person will be the program champion and lead a team of cross functional leaders that develop the strategy and plans for development projects. The GPL is the primary liaison between team/sub-teams and senior leadership and has overall accountability for the integrated strategy.

    Key Responsibilities
    • Lead the GPT (Global Program Team) in the generation of a Target Product Profile and the cross-functional compound development and lifecycle strategy taking global considerations into account. 
    • Lead GPT in development of forward-looking integrated development plans that are aligned with program strategy and ensures assumptions and drivers are aligned with plans to inform financial planning.
    • Lead efforts in partnership with line functions to optimize value of the compound throughout its lifecycle.
    • Ensure potential risks are identified and contingency planning with a solution focused mindset.
    • Ensure cross functional partnerships and resources are leveraged effectively, and with accountability, to achieve program objectives.
    • Drive collaboration and transparency across all functions and challenge team members to be broad and inclusive in their strategy planning.
    • Resolve conflicts, provide and receive feedback to develop and maintain a high performing team and if necessary escalate team member performance related issues to functional management.
    • Ensure that team recommendations are brought to appropriate governance for management buy-in and decisions.
    • Ensure alignment of program strategy/plan/execution with management and corporate expectations & priorities.
    • Lead GPT in the development of scenarios and recommendations and present for decision making at various governance bodies.
    • Single point of contact on program for senior and functional management.
    • Ensures communication of rationale and context for decisions made to team.
    • Leads team in developing a comprehensive internal and external communication plan with team input for important program milestones, key data, etc.
    • Reviews and agrees to publication plan, reviews publication concepts, presentations and manuscripts.
    • Primary source for information as needed for external communications (press releases, investor related, etc.).
    • Reviews health authority related documents and ensures consistency with strategic objectives for the program.
    • Timely progress and execution against strategy and plans.
    • Timely and aligned input into drivers for portfolio planning and budget process.
    Desired Skills & Experience
    • 8 — 12 years of pharma/biotech industry experience in drug development including experience in early phase non-clinical and/or clinical drug development and regulatory knowledge.
    • Strong knowledge and understanding of the science of the therapeutic area. 
    • Demonstrated ability to lead the development of project strategy and be accountable for project plans, timelines, progress, and outcomes.
    • Demonstrated experience leading and motivating teams in a matrix environment.
    • Demonstrated ability to cultivate excellent cross-functional collaborations.
    • Strong organizing and project management skills.
    • Demonstrated ability to effectively communicate at multiple levels of an
    • Demonstrated success in influencing colleagues and leaders in various departments.
    • Must demonstrate high integrity.
    Education & Minimal Requirement

    College degree in a scientific, medical, or business discipline is required. A graduate degree such as M.D., Ph.D., or PharmD is highly desired and will make the candidate most competitive.

    Please click HERE to submit your resume and cover letter. (Make sure to click Upload button on bottom left after your file selections)

  • Summary of Position

    Viela Bio is looking for a highly motivated, entrepreneurial Clinical Data Manager (DM) to join a fast-paced Data Sciences group. The DM reports through to the Senior Director, Data Sciences. In this position the individual ensures successful execution and coordination of Clinical Data Management (CDM) activities to support the delivery of drug projects which advance treatments for those suffering from severe inflammation and autoimmune diseases.

    Key Responsibilities
    • Serves as an expert in end-to-end CDM, providing oversight and advice to the clinical project team regarding CDM activities and deliverables.
    • Manages and resolves issues related to CDM deliverables by developing solutions to complex problems.
    • Develops clinical project standards and processes based on industry best practices.
    • Reviews, assesses and manages CRO delivery against KPIs and overall DMC performance.
    • Manages external data processes, including setup and reconciliation.
    • Other duties as assigned.
    Desired Skills & Experience
    • Minimum of 5 years of Data Management experience in the Biotech/Pharma/CRO industry.
    • Demonstrated knowledge of drug development process.
    • Demonstrated current understanding of GCP and regulatory requirements as they relate to data management systems and activities, and Good Clinical Data Management Practices.
    • State-of-the-art understanding of database structures and data standards (CDISC).
    • Experience with clinical data management systems and electronic data capture (EDC).
    • Excellent verbal and written communication skills. Strong leadership skills. Excels at making good decisions and priority setting.
    Education & Minimal Requirement
    • Education: Minimum of a BS in life sciences degree and/or equivalent experience.
    • CCDM preferred.

    Please click HERE to submit your resume and cover letter. (Make sure to click Upload button on bottom left after your file selections)

  • Summary of Position

    Viela Bio is looking for a talented and highly motivated Senior Quality Specialist. This person will be responsible for the execution of the Viela Quality System and associated support processes and will interface directly with 3rd part vendors, Research, Development, CMC, Clinical Development and Operations leadership teams to support and achieve Quality and Compliance goals. Input on key global QA / Compliance and business initiatives.

    Position includes the following: GxP Auditing of internal and external services utilizing risk-based strategy; Managing Document systems; Change management utilizing a risk-based approach and root cause analysis. Implementing and utilizing Quality Management tools (Paper/Electronic system). Product release utilizing systematic process flows. Training Management. Review documents such as SOPs, deviations, change control requests, corrective and preventive action plans, validation protocols/reports, technical reports, etc., that are submitted to QA for approval. Interprets and implements quality procedures, manages quality systems and assists in facilitating regulatory compliance inspections. Strong time management skills. Support during Regulatory Inspections and 3rd party audits.  May travel to oversee vendors.

     

    Key Responsibilities
    • Execute GxP Quality systems including Vendor Oversight, Documentation Management, training and GXP audits.
    • Support Regulatory and 3rd Party Audits and Inspections.
    • Oversee GMP operations at CMOs including quality review of batch records, analytical data, and lot disposition activities of, bulk substance, drug product, packaged and labeled drug products.
    • Lead investigations for any non-conformances during GxP activities.
    • Lead and conduct GxP audits on suppliers, issue audit agendas, reports, findings, perform follow-up actions and escalate findings to management as necessary.
    • Oversee GCP compliance with respect to clinical site and CRO audits.
    • Oversight qualification of all GxP vendors.
    • Oversight of clinical trial execution.
    • Conduct pre-audit and pre-inspection quality reviews to ensure better audit/inspection outcomes; Oversee the audit response process for the Investigator Site and Contract Research Organization (CRO) audits/inspections and ensure acceptability of actions to address findings.
    • Ensure compliance with applicable internal and external regulations, standards, policies and procedures related to the quality and regulatory status and performance of company operations, processes and products, including GMP, GLP, and GCP.
    • Maintain compliant quality system that adheres to regulatory expectations both internally and with respect to oversight of the company’s suppliers.
    • Work with CMC, non-clinical, clinical, regulatory, etc as an active cross-functional team member to ensure the appropriate document/data integrity for regulatory submission and regulatory inspections to ensure that the organization is inspection ready.
    • Interfaces directly with Research, Development and Clinical; actively influence and participate on quality compliance initiatives from a tactical GxP compliance perspective.
    Desired Skills & Experience
    • 5 years of experience with increasing levels of responsibility within the Quality and/or Compliance area.
    • Knowledge of US and Worldwide GxP regulations and experience with regulatory compliance inspections.
    • Compliance / QA experience at biopharmaceutical.
    • Extensive experience with electronic GxP systems approaches and implementation of such systems.
    • Proven ability to work in a collaborative team environment across multiple technical functions.
    • Ability to effectively interact with both global functional areas (GxP) and manufacturing sites (GMP) and third-party vendors.
    • Strong organizational skills.
    • Excellent interpersonal skills (including, listening, writing, negotiation, facilitation, attention to detail and presentation skills).
    Education & Minimal Requirement
    • BS. in Biology, Chemistry, Engineering or related fields preferred.

    Please click HERE to submit your resume and cover letter. (Make sure to click Upload button on bottom left after your file selections)

  • Summary of Position

    Viela Bio is looking for a highly motivated, entrepreneurial individual to lead bioassay group within Analytical Sciences to support development and commercialization from pre-clinical to MAA, and post approval life cycle management.

    Key Responsibilities
    • Lead Bioassay Development group. Responsible for development, optimization and transfer of cell-based bioassay, immunoassay, and nucleic acid assays to QC (Quality Control) laboratories.
    • Build in house early and late stage bioassay capability. Generate and characterize cell lines: maintenance of cells, transient transfection, virus transduction, stable cell line generation, single-cell cloning, flow cytometry and immunocytochemistry, immunoblotting, high content screening.
    • Lead search, selection and supervision of external CROs.
    • Author and review regulatory filings.
    • Recruit, coach and develop talents to achieve high performance consistently.
    Desired Skills & Experience
    • Deep understanding in underlying biology mechanism and assay principle of cell-based assay development with experience in stable cell line generation and cell-based assay development to assess the potency of drug candidate according to the regulatory guidelines.
    • Experience with development and commercialization of cell-based bioassays and binding assays are required. Immuno-chemistry and DNA experience is preferred
    • Experience in applying a variety of biochemical, biological, and immunological techniques (cell-based assays, FACS, ELISA, homogenous FRET assays, in-cell westerns, reporter gene assays, qPCR, ADCC and CDCetc.)
    • Experience working with stable cell line generation, flow cytometry, and BSL2 level biological agents.
    • Experience with multiple PCR and molecular cloning techniques, as well as protein expression in mammalian cell systems is preferred.
    • Design and generate knock-out and knock-in cell lines with genome engineering.
    • Proficiency to utilize statistical software for design of experiments and dose-response curve analysis (PLA, JMP, DoE, SoftMax Pro, etc.).
    • Experience in cGMP and QC practices required.
    • Broad knowledge of protein chemistry and structural-function characterization of biologics preferred
    • Strong leadership, collaboration and communication skills.
    • Prior people management experience preferred
    Education & Minimal Requirement
    • PhD in Cell Biology, Molecular Biology, or related field with 3-10 years of pharmaceutical or related industry experience
    • MS in Cell Biology, Molecular Biology, or related field with 7-15 years of pharmaceutical or related industry experience
    • BS in Cell Biology, Molecular Biology, or related field with 10-18 years of pharmaceutical or related industry experience

    Please click HERE to submit your resume and cover letter. (Make sure to click Upload button on bottom left after your file selections)

What to Expect When Applying

Thank you for your interest in joining our team. Your application will be reviewed by a member of our team and we will reach out should your experience and interests align with the role.

We receive applications from many interested candidates for each position and are not able to respond to every single candidate. However, please be assured that we do keep resumes on file and review them when new positions open.

In the meantime, please follow us on LinkedIn to receive updates on our progress and new job opportunities.