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 motivation bioanalytical scientist with advanced experience in PK, ADA, and biomarker method development, troubleshooting, and validation.  You will be responsible for development and qualification of new methods and support or lead externalization of developed methods.

    Key Responsibilities
    • Develop and qualify quantitative PK and biomarker immunoassays according to program needs
    • Develop and qualify immunogenicity methods (ADA and neutralizing antibody)
    • Critically evaluate and ensure scientific quality of generated data
    • Where necessary, develop solutions to and overcome issues with established methods
    • Prepare method procedures, qualification, and bioanalytical study reports
    • Support and/or lead transfer of methods to CRO and manage incoming data/reports and timelines
    • Ensure quality of outsourced data and adherence to appropriate guidelines
    • Work collaboratively with other members of the team to generate and evaluate sample analysis data
    • Manage internal and external timelines related to assigned responsibilities, and prioritize where necessary
    • Support bioanalytical writing efforts for regulatory documents
    • Present data in group and project team meetings
    • Help manage sample receipt and inventory
    • Oversee reagent inventory and characterization
    • Liaise with other functions to support Translation Science activities and needs
    • Evaluate and implement, as appropriate, new methodologies to support advancement of drug development programs
    • Stay up-to-date with industry thinking on bioanalytical approaches; and where possible present data at scientific conferences
    Desired Skills & Experience
    • Proven ability in immunoassay development for ELISA and MSD based systems a must
    • Familiarity with alternate high sensitivity detection systems such as Quanterix Simoa preferred
    • Experience with and knowledge of regulatory guidance requirements
    • Familiarity with current industry thinking on biomarker development
    • Excellent oral, interpersonal, and written communication skills
    • Has a collaborative and team-oriented mindset

     

    • Manages multiple projects with field work
    • Has been a MSL for >18 months in the NMOSD or other appropriate therapeutic area
    Education & Minimal Requirement
    • Minimal B.S. or M.S. Degree in biology, chemistry, immunochemistry, biochemistry immunology or related field
    • Minimum 5+ years in bioanalytical development

    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)

  • Summary of Position

    Viela Bio is looking for a talented and highly motivated Clinician to join our team. This position will have full responsibility for the planning, implementation and daily operation of drug development projects. He or she will collaborate with key internal and external stakeholders to support company initiatives that improve the quality and content of all clinical programs to deliver our portfolio.

    Key Responsibilities
    • Will be responsible for delivery of development projects.
    • Direct/Oversee the design and implementation of early stage clinical projects, as a member of our Product Development Team (PDT) and leader of the Clinical Sub-Team (CST). Ensure that the overall scientific and medical content of all clinical programs is scientifically and clinically rigorous.
    • Prepare clinical development plans that integrate pre-clinical and early clinical findings while working to ensure cross-functional alignment on an ongoing basis throughout the early phases of clinical development.
    • Design scientifically rigorous and maximally cost-effective clinical protocols that are aligned with the clinical development plan.
    • Present and defend protocols and clinical development plans at internal governance forums.
    • Serve as Medical Monitor, responsible for the safety monitoring of clinical trials, and as medical expert for Phase I/II/III studies, managing the process from protocol development through study execution to completion of study reports and integrated regulatory documentations.
    • Monitor study progress, ensure proper study conduct and adherence to the protocol, lead data review, evaluation, and analyses with support from Data Management and Stats & Programming team.
    • Present study updates, interim results, and final headline data to senior management as required.
    • Provide medical input and contribute to the clinical development sections of regulatory documents such as Dossiers, BLAs, INDs, Safety and Annual reports, handling of responses to regulatory agencies regarding questions about complex clinical development issues (e.g., safety or efficacy).
    • Ensure that Serious Adverse Events are properly reported on a global basis.
    • Direct responsibility for leading a team of Clinical Development professionals and ensure delivery of their portfolio of assets.
    • Implement clinical R&D policies, SOPs and related directives.
    • Review potential in-licensing candidates and present recommendations to Senior Management groups.
    • Support any needed due diligence and prepare/present medically sound strategy and plans associated with advanced opportunities.
    Desired Skills & Experience
    • 5 plus years in clinical research and/or drug development in CRO, pharmaceutical environment, or academia.
    • Good understanding of the drug development process (especially early phase clinical trials), protocol writing & study conduct, data review and reconciliation, the principles of translational medicine, and what it takes to lead teams successfully.
    Education & Minimal Requirement
    • MD with a valid US medical license preferred; Medical specialty training in an area related to immune mediated diseases required, expertise in autoimmune diseases 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 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.

    Position Title: Clinical Project Coordinator, Clinical Operations

    Position Reports to: Associate Director/Director Clinical Operations

     

    Key Responsibilities
    • Clinical Project Coordinator is responsible for supporting Clinical Operation Team members with the tasks associated with implementation and conduct of clinical trials. Qualified candidates will demonstrate the ability to coordinate and prioritize multiple tasks, have good computer skills, and practical clinical trial experience.

          Major Duties and Responsibilities:

    • Set-up and maintain electronic trial master file and ensure compliance with applicable SOPs
    • Create, implement, and maintain systems to track study metrics (CTMS)
    • Generate purchase orders, process vendor invoices and assist in tracking spend against approved budget
    • Initiate vendor contract requests and track ongoing status of legal review and approvals
    • Schedule team meetings and prepare agendas
    • Develop study specific procedures and tools
    • Assist clinical operations team with study management
    • Participate in vendor selection and assist with ongoing vendor management
    • Assist in the organization of advisory boards and investigator meetings
    • Assist in the clinical trial insurance process. Track approvals, revisions and renewal of certificates
    Desired Skills & Experience

    Experience

    • Minimum of 2 years clinical trial experience at a commercial or academic research center, Clinical Research Organization or Sponsor Company

    Special Skills/Abilities

    • Professional demeanor and ability to work as a team member
    • Experience with Microsoft Office Suite (Word, Power Point, Excel)
    • Experience with electronic Trial Master File programs (Veeva Vault preferred)
    • Ability to coordinate and prioritize multiple tasks
    • Demonstrated verbal and written communication skills
    • Demonstrated interpersonal and problem-solving skills
    • Proactive approach and the ability to act independently
    Education & Minimal Requirement
    • Bachelor’s Degree 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, Market Access & Value This person will be responsible for gaining and maintaining broad coverage/access for Viela Bio products within commercial and government payer segments. The Director, Market Access & Value will act as lead contact for payer related account management.  They will be responsible for creating, implementing and executing account business plans that serve as a road map for strategic and tactical plan execution.  This role will interface with other functional areas including distribution, sales, marketing, patient support services, patient advocacy and compliance.

    These field-based positions report to Senior Director, Market Access & Value.

    Key Responsibilities
    • Obtain and maintain broad access for Viela Bio promoted products access with commercial and government payers
    • Build access with payers with focus on key policy decision makers.
    • Assess and address any payer barriers to Viela Bio products.
    • Provide marketplace feedback in a timely manner on customer business trends, competitive updates and industry issues and opportunities.
    • The Director, Market Access & Value works independently in a fast paced, highly visible environment as well as collaboratively with the internal program hub support services to ensure all customer needs are met.
    • Maintain a high level of awareness of public and private formularies, benefit structures, reimbursement mechanisms, legal and regulatory influences, health management programs and product distribution knowledge to accomplish objectives
    • Create and modify account specific business plans and achieve the established goals for the accounts such as formulary status and pull-through
    • Develops strong, collaborative working relationship with internal Viela Bio stakeholders.
    • Maintain an in-depth knowledge of the Viela Bio portfolio and competitive products
    • Deliver key value messages on Viela Bio products
    Desired Skills & Experience
    • Prior work experience (10 yrs.) in biotech/pharmaceutical industry in national accounts management including commercial and government payers
    • Extensive understanding of Market Access, both pharmacy and medical covered products
    • Strong established relationships with key payers and decision makers
    • Proven success in new product launches with payers and PBMS, preferably orphan/ultra-orphan products
    • Broad understanding of orphan disease space
    • Overall knowledge of delivery and reimbursement of healthcare in U.S.
    • High level of integrity and accountability
    Education & Minimal Requirement
    • Bachelor’s Degree required in health care related field or business

    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, detail-oriented IT Enterprise Architect who flourishes in high-pressure environments. The individual will play a strategic technical role in building and maintaining all IT systems (primarily cloud based) including the front-end platforms, servers, storage, and networks.

    To be successful in this role, the individual should have excellent technical, analytical, and project management skills. Strong leadership, communication, and interpersonal skills are critical for the role.

    Key Responsibilities
    • Set the technical direction and approach for integrating Viela information applications and contents.
    • Partner with Viela IT leadership to create a well-informed cloud strategy and manage the adaption process.
    • Improve the current Viela IT infrastructure, develop and lead the implementation for optimized infrastructure design and the build-up of Viela cloud based digital landscape.
    • Be responsible for developing, maintaining, and enforcing overall enterprise architecture models, capabilities to adequately perform Viela’s business and technology activities.
    • Partner with IT leadership and IT business partners to create business architecture models that reflect Viela’s strategies and goals and support the implementation of business visions and goals.
    • Follow Viela IT security strategy, ensure Viela IT operating environments stay safe and secure, monitor company’s cloud security and privacy.
    • Collaborate with managed service partners to implement the solid endpoint protection program.
    • Evaluate and provide recommendation to improve technical operations of managed service vendors.
    • Identify the top cloud architecture solutions to successfully meet the strategic needs of the company.
    • Ensure changes to Viela Information Systems adhere to the regulatory and compliance requirement.
    • Lead the effort of technical documentation.
    • Respond to technical issues in a professional and timely manner.
    • May support end users for general IT related issues.
    Desired Skills & Experience
    • 10+ years’ experience in designing and delivering information systems, especially in the system/solution architect role and preferred with biotech and pharmaceutical companies.
    • Excellent knowledge of cloud computing technologies and current computing trends.
    • Extensive experience with enterprise architecture best practices and goals
    • Demonstrated track record of successful Agile delivery of IT systems in regulated environment.
    • Strong ownership and sense of urgency in responding to business needs.
    • Strong problem solving and issue resolution skills.
    Education & Minimal Requirement
    • Bachelor degrees or equivalent, Master’s degree preferred.
    • Bachelor or equivalent in Technical or Science, 15+ years working experience
    • Master degree in Technical or Science, 10+ years working experience

    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 seeking a talented and highly motivated Regulatory Affairs professional to lead CMC regulatory strategy for Viela Bio clinical portfolio development from pre-clinical to commercialization.

    Key Responsibilities
    • Develop and implement CMC regulatory strategy as the Regulatory-CMC representative on assigned project teams
    • Lead the CMC working group responsible for development of regulatory submissions within assigned product portfolio
    • Responsible for collection, preparation and assembly of CMC documentation required for US and RoW regulatory submissions (IND, CTA, IMPD, BLA, MAA, etc.)
    • Liaise/collaborate with other project team members/CROs to ensure the timely preparation and receipt of information required for regulatory submissions
    • Monitor related corporate activities for regulatory compliance regarding manufacturing and development in support of assigned projects
    • Plan, coordinate, prepare, and execute for meetings with regulatory agencies
    • Interpret existing regulations and guidance documents to provide strategic guidance for project teams
    Desired Skills & Experience
    • Excellent oral and written communication skills
    • Strong interpersonal/group skills; capable of working collaboratively with colleagues in all functions
    • Self-motivated, self-aware, and action-oriented
    • High standard of professional ethics, integrity and trust
    • Excellent planning, organizational and prioritizing skills with ability to multi-task.
    • Consistently high professional image and demeanor
    • Proficiency in the use of MS WordÒ, ExcelÒ and other appropriate software programs
    • Experience in cGMP and technology transfer required, such as document management, deviation root-cause analysis, CAPA and change control
    Education & Minimal Requirement
    • BS/MS in a scientific discipline with a minimum of 3-5 years in Regulatory Affairs function with an additional 6-8 years in a related field of biopharmaceuticals, or equivalent.

    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.