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 Senior Statistical Programmer with clinical trial knowledge and advanced SAS programming skills to join our Data Science division. You will not only provide programming support and/or lead all programming related activities of the clinical data analysis but also contribute to the improvement of overall efficiency and productivity in our programming group by developing/maintaining the analysis and production programming tools.

    Key Responsibilities
    • Generate and validate Study Data Tabulation Model (SDTM)/Analysis Data Model (ADaM) databases, Tables, Figures and Listings (TFL) outputs in the delivery of the clinical study report (CSR)
    • Review and provide feedback on eCRF designs, eCRF annotations, Database structures, SAPs, SPPs and data specification.
    • Interact closely with Statisticians, Data Management, Clinical Development or other cross-functional teams to provide programming support in analysis and reporting activities including, but not limited to, ad-hoc analysis, data exploratory analysis, regulatory submissions, and the scientific publication for Viela Bio products
    • Produce and maintain technical database standards and programming specification documents
    • Develop, enhance, evaluate and validate SAS macros, utilities or modules to standardize routine programming activities of clinical data analysis and reporting
    • Lead and contribute to the development of best practice to improve quality, efficiency and effectiveness in programming group
    Desired Skills & Experience
    • Strong SAS programming skills with Base SAS, SAS/STAT, SAS SQL and SAS Macro language
    • Exposure to Unix scripts, VBA scripts, SAS/GRAPH, R, SQL, etc. a plus
    • Knowledge of CDISC standards and industry best practices a plus
    • Experience in developing SAS Macro and utility tools with complex dataset.
    • Strong communication, teamwork and interpersonal skills to enjoy collaborating as part of a dynamic team
    • Attention to details, strong problem-solving skills and ability to manage concurrent projects and activities
    • A minimum of 3-5 years of clinical trial programming experience using SAS within pharmaceutical, biotechnology, and/or contract research organization industries
    Education & Minimal Requirement

    Minimum BS (MS preferred) with concentration in Life Sciences, Computer Science, Mathematics, Statistics or a quantitative/analytical field.

    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 talented and highly motivated Senior Manager/Associate Director, Business Development. As part of the Business Development (BD) team, this individual will be responsible for building the early-stage Viela R&D portfolio through in-licensing and other types of partnerships as well as other BD activities. S/he will work with the BD team to structure, negotiate, and execute a range of business development transactions, including collaborations, licenses, partnerships and other agreements all aimed at helping Viela Bio develop and achieve its scientific portfolio and strategic objectives.

    Key Responsibilities
    • Support the growth of Viela Bio’s R&D pipeline by working with the BD team to identify, structure, negotiate and execute various BD transactions, including collaborations, licenses, partnerships and other agreements.
    • Lead the search-and-evaluation process to identify new opportunities and high-impact science across academic centers and biotechnology companies; proactively source, evaluate and prioritize scientific partnering opportunities and bring them forward for internal decision-making.
    • Develop and maintain business relationships with key external collaborators in the academic, research, biotechnology, pharmaceutical and venture communities. Leverage his/her scientific network to identify opportunities in areas of interest to Viela Bio’s strategy.
    • Facilitate scientific evaluations by leading cross-functional efforts that include other Viela business units (e.g. research, clinical, regulatory, CMC, commercial, legal, finance). Work closely with the research and clinical teams to understand and align on R&D strategy and direction.
    • Support due diligence efforts by managing workstreams and reviewing relevant counterparty materials.
    • Support preparation of presentation materials, reports, and updates for senior management briefings. Communicate deal strategy, progress and key issues to various stakeholder audiences.
    • Review and manage contracts and other legal deal documents. Develop thoughtful solutions to issues and play a key role in negotiations. Work with legal during contract review and execution.
    • Travel required.
    Desired Skills & Experience
    • 8+ years of business development or related experience, preferably in biotech; deal sheet demonstrating experience and specific roles.
    • In-depth knowledge of drug R&D process and regulatory, reimbursement and commercial environments.
    • Scientific understanding of, and experience in, the immune biology space.
    • Strong scientific and industry network and proven ability to forge professional relationships.
    • 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 internal and external multidisciplinary teams (e.g. R&D, commercial, legal, Finance and Ops).
    • Excellent written and verbal communication skills and ability to “think on your feet”.
    • Able to excel in a very fast-paced and changing environment, and 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

    Advanced degree required, PhD and/or MBA.

    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 candidate for Director/Senior Director Patient Access and Hub Services. This person will design and implement patient services/HUB programs while also managing the ongoing operations. These services/programs will support the needs of patients with rare auto-immune diseases. In addition, this individual will develop HUB and co-pay assistance strategy, lead the selection and contracting of service providers and manage all contracted reimbursement and customer service operations while supporting a culture of transparency, collaboration and growth. Responsibilities include ensuring Viela Bio’s HUB and co-pay assistance operations provide the highest level of customer service in helping patients start and stay on Viela Bio’s products.

    This individual reports to the Vice President, Market Access and has oversight responsibility for contracted reimbursement case managers, customer service specialists and other external vendor partners. This role is responsible for collaborating with multiple functional groups, including but not limited to Sales, Marketing, Market Access, Commercial Operations, Patient & Professional Engagement, Medical Affairs, Legal, and IT.

    Key Responsibilities
    • Provide leadership, oversight and management to ensure the effective functioning of the HUB and co-pay assistance program by establishing and monitoring program goals and key performance indicators.
    • Ensure HUB performance is communicated to key stakeholders by developing and implementing performance dashboard and improvement plans as needed.
    • Lead cross functional teams to develop program enhancements that will optimize customer service and patient access by identifying emerging service opportunities.
    • Build and develop productive working relationships with external service providers and internal cross-functional stakeholders.
    • Negotiate and execute complex contracts/SOWs for desired services.
    • Monitor and assess performance of external services partners, ensuring they perform in accordance with agreed upon contracts. Put appropriate corrective measures in place and/or develop alternative solutions to address performance issues.
    • Analyze HUB and co-pay operating data to identify trends and opportunities for process/program improvement. Oversee design, development and implementation of workflows to assure seamless experience for customers.
    • Develop and maintain all program materials, including call guides, SOPs, work instructions and training resources per Viela Bio’s legal, medical and regulatory approval process.
    • Ensure that contracted patient services team, other external services partners/HUBs, and internal stakeholders (marketing, market access, trade and sales) are properly educated on the features and benefits of patient services programs.
    • Oversee development and management of HUB operations budgets and forecasts.
    • Ensure that all actions, and those of his/her team both internally and through vendors working on our behalf, are compliant with all laws, regulations and policies and demonstrate Viela Bio values.
    Desired Skills & Experience
    • Minimum of 6-8 years commercial or operations experience in biotech/pharmaceuticals with at least 5+ years leading large, complex HUB operating teams.
    • Experience managing multiple patient service vendors.
    • Product launch experience desired.
    • Self-directed, hands on approach.
    • Analytic skills, project management and excellent written and verbal communication skills.
    • Travel: as needed
    Education & Minimal Requirement
    • Bachelor’s degree (or equivalent) in Business, scientific or related field; advanced degree 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 IT System Analyst to support both IT/business system implementation projects and services.

    It is an excellent opportunity to develop technical skills and gain business knowledge in many different areas – from ERP to commercial and marketing.

    The person spends his/her time split between projects and services and is accountable for the delivery of the technical solutions from implementation to maintenance. The System Analyst actively involved in system configuration and enhancement as well as system administration and end user support. This position will require constant collaborative interactions with business partners across functional groups. Strong interpersonal and communication skills are essential to establish strong relationships with business stakeholders to understand the strategic direction and priorities.  Experience in Agile delivery/Rapid deployment in a fast-paced regulated environment is critical for the success of this role.

    The System Analyst needs to be up-to-date with relevant knowledge in technology domain. Experience and good understanding of pharmaceutical and biotech industry and working experience in regulated environment is desirable.   Good communication and facilitation skills with a strong desire to learn new skills and technology is a must. The ability to work with others collaboratively to achieve objectives is key requirement for this role.

    Key Responsibilities
    • Develop and configure solutions as required from conceptualization through to stabilization using various computer platforms (example systems: Sharepoint, Veeva Vault, Netsuite)
    • Deliver enhancements to systems/applications.
    • Perform system/application maintenance and support activities.
    • Perform impact assessment and developing implementation plan for new releases of SaaS systems.
    • Participate in development and execution of test plans for systems/solutions.
    • Functional & technical requirements development and management.
    • Support end users for general IT related issues.
    • Develop training material and provide end user training for Viela systems when needed.
    • Ensure changes to Viela Bio Information Systems adhere to the regulatory and compliance requirement.
    Desired Skills & Experience
    • Experience with Veeva Vault implementation and support
    • Experience in building business application using Sharepoint platform
    • Experience in define and build testing plan and test scripts for validated systems
    • Work experience in delivering information systems for pharmaceutical/biotech industry.
    • Demonstrated track record of successful Agile delivery of IT systems in regulated environment.
    • Experience of working with cloud platforms
    • Strong ownership and sense of urgency in responding to business needs.
    • Technical savvy with ability to quickly master a new technology and system.
    • Excellent verbal, written communication, relationship management, and influencing skills.
    • Entrepreneurial spirit, the ability to foster relationships, and the ability to develop innovative ideas and solutions.
    • Experience working in a fast-paced organization and strong desire to learn new skills.
    • Strong problem solving and issue resolution skills.
    Education & Minimal Requirement
    • Bachelor degrees in Technical or Science, Master’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 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)

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.