JOIN US

As an emerging leader in biotechnology, our talented, entrepreneurial, and collaborative teams are critical drivers of our success. If you are looking to expand your knowledge, deepen your experience, and collaborate with scientists motivated to deliver life-altering medicines to people in need, Viela Bio may be the place for you.

Viela Bio offers competitive packages including:

  • Medical, Dental, Vision coverage
  • Matching 401k program
  • Life and AD&D insurance
  • Short Term and Long Term Insurance coverage

Please see our current open positions located in our Gaithersburg, MD office. Please submit your resume and cover letter follow the link at the bottom of the Job Description for the position you are interested.  For additional information please email hr@vielabio.com. We will reach out to you should your experience and interests align with our needs.

Manager/Sr Manager, Clinical Operations - Job Ref ID: 2019-010

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 and Experiences:

  • 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:

  • 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)

Senior Manager, Strategic Insights - Job Ref ID: 2019-016

Summary of Position

Viela Bio is looking for a talented and highly motivated a Senior Manager, Strategic Insights. This person will play a key role in mining critical insights from primary and secondary market data and research projects to drive strategic, evidence-based decisions. This person will work with external and internal partners to execute research projects that address therapeutic area business questions and strategy development as well as evaluating the performance of Viela Bio’s first commercial launch.

Key Responsibilities:

  • Responsibility for qualitative and quantitative primary market research projects along with analysis of secondary sources to address key business questions– understanding the business need; designing a project to answer the business question; executing the project in a timely manner within budget; presenting final results and strategic insights. 
  • Construct clear concise summary reports or dashboards summarizing insights for leadership that provide a snapshot of the market situation and implications for the business.
  • Probe beyond the descriptive insights provided in top line reports from primary market research to uncover diagnostic insights that explain the ‘why’s’ behind the reported results.
  • Analysis of patient level data to capture insights on treatment trends and patient management approaches.
  • Respond to ad hoc requests for key commercial and business insights;anticipate and answer the follow-on questions that will result. 
  • Provide insights to support the development of forecasting and strategic/tactical planning purposes.
  • Draft statement of work documentation to support engagement with healthcare practitioners and patients to ensure projects meet compliance and legal requirements.
  • Develop strong partnerships with cross-functional teams – marketing, medical, sales, business analytics, commercial operations and new products groups.
  • Incorporate future business needs in scope and design of projects.
  • Go beyond a project-based mindset and be a strategic partner. Offer strategic insights, communicate these clearly and ensure that these drive business decisions.

Desired Skills and Experiences:

  • 5 years of experience in [US & Global] market research, analytics and forecasting.
  • Analytical skills and Advanced capabilities in Excel, PowerPoint.
  • Self-starter who demonstrates energy and enthusiasm, bringing a positive can-do approach to all challenges.
  • Inquisitive approach to analytics – easily anticipates next steps.
  • Works well independently and collaboratively.
  • Detail-oriented.
  • Excellent project management skills.
  • Excellent oral and written communication skills.

Education:

Bachelor’s degree in life science and/or business / marketing; Master’s preferred.

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

Scientist II/Senior Scientist Bioinformatics, Research and Development - Job Ref ID: 2019-029

Summary of Position

Viela Bio is currently seeking a talented and highly motivated Bioinformaticist to support research activities related to immune-modulating drugs for autoimmune indications. This person will be responsible for supporting early stage pre-clinical as well as clinical programs.

Key Responsibilities:

  • Lead Bioinformatics for pre-clinical stage programs
    • Conceive informatics analysis strategies and independently execute bioinformatics analysis that support discovery and pre-clinical studies such as new target identification and biomarker development
    • Perform data analysis and prepare summaries of results
  • Support clinical-stage programs
  • Work collaboratively with Research, Translational & Clinical scientists to identify genes and pathways in human diseases through interrogation of complex multi-omics data sets generated from pre-clinical and clinical samples as well as through publicly available datasets
  • Present findings at external meetings and prepare manuscripts

Desired Skills and Experiences:

  • Deep understanding of relevant concepts in Immunology and autoimmune disease
  • Extensive knowledge of “big data” proteomics and transcriptomics required
  • Extensive experience in the use of a high-level programming language such as R (Bioconductor), MATLAB, Python or Perl for complex data analysis
  • Industrial experience is desirable
  • The candidate will be expected to analyze, interpret and present data sets and should have clear and effective presentation skills and be able to work independently with minimal supervision

Education:

  • PhD in Bioinformatics, Computational Biology or Biological Sciences with strong quantitative background, involving the analysis of large-scale complex data such as next generation sequencing.
  • 5-10 years experience in academia or in Industry

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

Senior Manager/Associate Director, Regulatory CMC - Job Ref ID: 2019-035

Summary of Position

Viela Bio is seeking a talented and highly motivated Regulatory Affairs professional to lead CMC regulatory strategy for Viela Bio product portfolio development from pre-clinical to marketing authorization, and post approval life cycle management.

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 forproject teams. 

Desired Skills and Experiences:

  • 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 Word, Excel 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:

  • BS/MS in a scientific discipline with a minimum of 3-5 years in Regulatory Affairs function with an additional 5-7 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)

Clinical Scientist - Job Ref ID: 2019-037

Summary of Position

The Clinical Scientistwill be responsibility for the planning, implementation and daily operation of drug development projects. S/he will contribute to and support Department/Clinical initiatives to improve the quality and content of all clinical programs as well as the cross functional/organization processes designed to effectively deliver our portfolio. 

Key Responsibilities:

We are seeking a well-trained individual with strong leadership skills who is driven by science and the desire to develop novel therapies for patients. This individual will have the opportunity for growth and development while working in a vibrant environment and “biotech” culture. The ideal candidate will have a mastery of the drug development processstudy document writing & study conduct, data review and reconciliation, the principles of translational medicine, and what it takes to lead teams successfully. 

Specific duties and major responsibilities include: 

  • Direct/oversee the design and implementation of early stage clinical projects and 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 long-term clinical development plan. 
  • Present and defend protocols and clinical development plans at internal governance forums. 
  • Serve as a functional area representative to cross-functional teams, providing oversight and guidance at the Product Development Team, Clinical Study Team, Clinical Trial Team, and Translational Science Sub-Team. 
  • Work closely with the Medical Monitor to assess study progress, ensure proper study conduct and adherence to the protocol, and 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. 
  • Prepare various official and regulatory documents for Regulatory and other agencies, 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).   
  • Lead cross-functional teams comprised of multidisciplinary professionals and clinical scientists 
  • Implement clinical R&D policies, SOPs and related directives. 
  • Review potential in-licensing candidates and present recommendations to Viela Leadership.  
  • Support any needed due diligence and prepare/present medically sound strategy and plans associated with advanced opportunities. 
  • Contribute and support Department/Clinical initiatives to improve the quality and content of all clinical programs as well as the cross functional/organization processes designed to effectively deliver our R&D portfolio. 

Desired Skills and Experiences:

  • At least 5 years of experience in clinical research (in an academic, pharmaceutical company, or CRO environment) related to the design and/or conduct of clinical studies is required. 
  • Experience in autoimmune disease clinical development and/or translational science desired. 
  • Excellent oral and written communication skills; strong interpersonal and listening skills. 
  • Results driven and able to achieve creative and sound outcomes. 
  • Proven leadership skills and demonstrated ability to interact collaboratively in a cross-functional environment. 
  • Ability to make sound and timely decisions; agile in learning and action oriented. 
  • High level of emotional intelligence; self-driven with the ability to function autonomously with minimal direct guidance. 
  • Able to relate to varied level audiences across organization; able to build and lead effective teams and coach & develop team members; able to set priorities for team and maintain accountability; skillful in negotiating organizational boundaries and hierarchy; experience managing and developing others. 
  • Able to balance scientific & business perspectives; able to delegate effectively; strategic thinker who can provide vision and purpose for teams; demonstrates managerial courage. 

Education:

  • PhD, PharmD, 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)

Associate Director, Quality Assurance and Compliance - Clinical - Job Ref ID: 2019-040

Summary of Position

Viela Bio is looking for a talented and highly motivated Associate Director, Quality Assurance and Compliance – Clinical. This person will be responsible for leading quality and compliance activities for GCP, GLP and GPvP in clinical trials globally. This includes the operation and continuous improvement of the Quality System in support of the Viela Bio’s pipeline.

The position oversees the clinical trial audit function and represents Viela Bio as the key QA liaison with external vendors and CROs. The position will also be responsible for implementing the company’s clinical quality systems and compliance strategies involving clinical trials working with key business partners in clinical and nonclinical to assure compliance with regulatory expectations utilizing risk-based approaches. Input on key global QA/Compliance and business initiatives as well as Support during Regulatory Inspections and 3rd party audits.

Work closely with key stakeholders in the development and implementation of GxP related quality systems and training of Viela staff. Develop and routinely monitor metrics to ensure compliance with operational oversight plans. Able to manage/plan/execute audits of investigator sites, documents, Trial Master Files, vendors, and internal and external processes.

Assure quality awareness in conducting clinical studies and convey confidence in clinical knowledge providing a high understanding of clinical processes. Expected to routinely interact with CROs, vendors and testing Labs to promote collaboration with these external partners to ensure all systems, processes, and their outcomes are in compliance with applicable standards, international regulations and guidelines. Must have ability to actively leverage audit outcomes and trends to achieve sustained improvement in conducting clinical trials.

Key Responsibilities:

  • Provides guidance to personnel performing investigations, root cause analysis, CAPAs and deviations associated with oversight of clinical trial execution.
  • Point person to identify and communicate GxP quality and compliance risks and participate in determination of appropriate plan for resolving the issues and addressing risks.
  • Works with clinical operations to develop and manage audit programs with appropriate risk assessment and mitigations for both internal and external audits.
  • Participates in cross-functional teams providing guidance and risk-based options representing Clinical QA on project teams.
  • Reviews clinical study documents and checks for consistency and appropriate standards and practices as applicable.
  • Provides resource planning and appropriate budget management of FTEs, consultants and contractors.
  • Hosts and manages regulatory and 3rd party audits and inspections.
  • Executes GxP Quality systems including Vendor Oversight, Documentation Management, training and GXP audits.
  • Ensures 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 GLP, GCP & GPvP.
  • Work with clinical, medical affairs, bio-statistics, research and data management 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.

Desired Skills and Experiences:

  • 12+ years of direct clinical (GCP, GLP and/or GPvP) Quality Assurance experience in regulated industry (pharma/biotech).
  • Broad knowledge of risk-based quality systems approaches consistent with ICH E-6(R2) for Good Clinical Practice (GCP).
  • Strong knowledge of GxPs related to clinical activities including but not limited to Good Clinical Practices (FDA and ICH), safety monitoring, clinical laboratories and the ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible and constructive manner.
  • Experience in leading inspection-readiness activities for FDA, MHRA, EMA, PMDA and other international regulatory agencies as applicable.
  • Maintains good working relationships and communication with all staff, contractor, consultants and external partners.
  • Extensive experience with electronic quality systems approaches and implementation of such systems.
  • Experience with user acceptance testing for external systems.
  • Understanding of requirements/documentation of system validation.
  • Knowledge of drug development, study design, data and trials management, procedures and documentation practices.
  • Able to work in a fastpaced environment while handling multiple demands and shifting priorities with flexibility and willingness to adapt in a changing environment.
  • Excellent communication skills, both verbal and written, strong analytical skills and attention to detail.

Education:

  • BA/BS (or MS or Ph.D.) in any Life Science discipline is required.

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

Director, Regulatory Affairs - Job Ref ID: 2019-041

Summary of Position

Viela Bio is seeking a talented and highly motivated Director Regulatory Affairs. This person will be responsible for supporting the Head of Regulatory in the execution of the regulatory strategy for the Viela Bio product portfolio.

Key Responsibilities:

ThDirector, Regulatory Affairs reports to the Senior Director of Regulatory Affairs and works with the Global Product Teams (GPTs)supporting the development and execution of the regulatory strategy for the Viela Bio product portfolio. 

  • Develop and implement innovative and effective regulatory strategies that may include pursuance of accelerated pathways, Breakthrough designation, Fast Track designation, Priority Review, Orphan designation, and Priority Medicines Scheme (PRIME) designation, in support of bringing our client’s portfolio of compounds through development and to the market.
  • Independently represent the regulatory affairs function at GPT meetings and provide updates regarding ongoing regulatory activities as well as collaborate with project management to drive these activities to completion. 
  • Work collaboratively with cross functional team members (Clinical Operations, Research, and Translational Scienceand key internal stakeholders to prepare for regulatory submissions including coordination of meeting requests, writing and management of briefing documents, leadership at both rehearsal and meetings/TCs, and appropriate follow-up and integration of results into global strategy.
  • Conducts regulatory review of clinical documents, including: protocols, informed consent, and clinical study reports.
  • Gather and analyze regulatory intelligence and independently keep abreast of new and changing regulations/guidance.
  • Develop, write, and implement standard operating procedures and/or instructions as needed.
  • Serve as the primary contact with regulatory agencies for assigned projects.
  • Interacts with company partners and consultants for various regulatory matters as needed.

Desired Skills and Experiences:

  • Strong working knowledge of US regulatory processes. Experience with global (EU/Japan) regulatory processes is a plus. 
  • Must have in-depth knowledge of regulatory requirements and guidance documents, including FDA regulations, ICH and EMA guidelines/directives. 
  • Experience interacting with CROs in the management of US eCTD IND submissions and ex-US CTAs towards clinical trial activations. 
  • Strong judgment and decision-making skills in making critical go/no-go decisions.
  • Ability to influence across functions or in a matrix environment requiring strong peer relationships and to provide leadership in situations of shared accountability or high level of ambiguity.
  • Self-aware and adaptable, adept at recognizing his/her own strengths, limitations and motivations.  A strong results-driven personality with a high level of enthusiasm and energy capable of acting with authenticity and ego maturity and of actively seeking feedback and recognizing impact on others.
  • Demonstrated ability to influence across functions or in a matrix environment requiring strong peer relationships and to provide leadership in situations of shared accountability or high level of ambiguity.
  • Willingness and ability to adhere to the Company’s Approach, Culture and Values.
  • Strong independent research capabilities using available paper and electronic resources.
  • Proficient user of standard MS Office suite (Word, Excel), experience using electronic document management systems and document review tools required. 

Education:

  • Advanced degree (Pharm.D., or Ph.D. preferred) in life sciences or a relevant discipline with at least 5-8 years of experience in a regulatory affairs function in a biopharmaceutical company.

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

Marketing Operations Coordinator/Manager - Job Ref ID: 2019-042

Summary of Position

Viela Bio is looking for a talented and highly motivated Marketing Operations Coordinator/Manager. This person will be responsible for managing the production, fulfillment and inventory management of the promotional materials and the promotional review process at Viela Bio.  This includes, but is not limited to, facilitating review meetings, tracking all materials throughout the approval process, working with agencies on production, and ultimate delivery and distribution to end-users.  Additionally, this role will play a key part in defining Viela Bio’s Commercial support structure, processes and day-to-day operations in support of our internal teams, customers, and patients.  Finally, this position will provide overall budget tracking, project management expertise and day-to-day management of key initiatives and special assignments aligned with the commercial organization.

Key Responsibilities:

  • Medical/Legal and Promotional Review
    • Primary commercial team contact for all submissions, tracking, approvals, project management, and Veeva PromoMats processing as it relates to Viela Bio Medical/Legal and Promotional Review.
    • Schedule and facilitate all Medical/Legal and Promotional Review meetings taking into account timelines/prioritization for all projects and future requirements.
    • Capture changes/edits during MLR meetings and incorporate them into updated material drafts.
    • Route and monitor promotional review materials, including revised versions in the Veeva Vault electronic review system, and ensure Veeva CRM materials are available.
    • Manage proofing of materials and print production, including notifying material release to project originators and external partners.
  • Marketing Operations
    • Work closely with Viela Bio internal stakeholders, external agencies and fulfillment partners to resolve any questions or issues that impact ability to deliver promotional content externally.
    • Own the relationship with our fulfillment partner and manage inventory of professional/consumer promotional materials.
    • Manage the Viela Bio Speaker’s Bureau and work with our external partner to coordinate logistics, materials and any other related item to Speaking Programs as needed.
    • Act as the Commercial Team’s primary point of contact for all symposia, conference and convention involvement – including but not limited to logistical support, material fulfillment, booth attendee coordination and site management.
    • Support Viela Bio’s Sales and Marketing teams with ad hoc requests related to promotional materials, field inquiries and general support.
  • Project Management Support and Budget Tracking
    • Plan and monitor sales and marketing projects to ensure resources are aligned, work is delivered on time, and projects are executed efficiently.
    • Oversee project priorities, identify potential risks, and actively implement solutions to address them in advance.
    • Meet with cross-functional team members to identify and resolve issues.
    • Work with team members to monitor and track the overall commercial budget
    • Prepare status reports by gathering, analyzing and summarizing relevant information.
    • Communicate project timelines to Viela Bio stakeholders and external partners to manage competing commercial objectives.
    • Support evolving goals for Marketing Operations, reflecting clear alignment with the Commercial organization’s strategic priorities and tactical implementation.
    • Establish collaborative relationships within Viela Bio through frequent communication and interaction to understand needs and optimize effectiveness.
    • Other duties as assigned.

Desired Skills and Experiences:

  • Previous Medical/Legal and Promotional Review coordinator experience.
  • Previous experience in a commercial support role – marketing and/or sales operations, administrative support, field sales coordination.
  • Experienced in Veeva PromoMats platform as an administrator.
  • Superior organizational skills, solutions-oriented, and highly detailed.
  • Proficient in Microsoft Office (Excel, Word, Powerpoint, Outlook).

Education:

  • Preferred Bachelor of Science or Master’s degree

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

Senior Manager/Associate Director, IS Solution Delivery and Management - Job Ref ID: 2019-053

Summary of Position

Viela Bio is looking for a talented and highly motivated, entrepreneurial Sr Manager/Associated Director, Solution Delivery and Management. This person will be responsible to drive technology enablement and innovation into business process and operations, as well as monitor and manage the health of the systems and services delivered. The individual needs to have solid domain knowledge of biotech and pharmaceuticals Sales & Marketing Commercial Operations. Business analysis skills are important to understand business needs and translate into functional and technical specifications. The person is accountable for the delivery of the technical solutions from technology evaluation, implementation to maintenance. This position will require constant collaborative interactions with business partners across functional groups. Strong interpersonal skills, outstanding verbal and written communication skills are essential to establish strong relationships with business stakeholders to understand the strategic direction and priorities. The person will be involved in technical design, development and documentation of solutions as needed and actively involved in system configuration and enhancement and support of end users. Experience in Agile delivery in a fast-paced regulated environment is critical for the success of this role.

Key Responsibilities:

  • Lead cross functional team and vendors to deliver IT systems that support Viela Bio business – ensure requirements are clearly understood, properly translated into needed technical components meeting the business intent.
  • Proactively identify Viela Bio technology needs in collaboration with functional groups. Contribute to the IT portfolio development and priority setting/investment decision making.
  • Ensure changes to Viela Bio Information Systems adhere to the regulatory and compliance requirement.
  • Manage vendors to ensure high quality delivery from vendors per contract terms.
  • Keep up-to-date with relevant technology supporting Viela Bio business to ensure fit-for-purpose, scalable technology implemented to support Viela Bio’s growth.
  • Serve as the system owner and administrator of Viela Bio systems ensure technology/systems properly managed and maintained. Partner with business owners ensure the proper control of system access and content management.
  • Develop and configure solutions from conceptualization to stabilization using various computer platforms.
  • Deliver enhancements to systems/applications.
  • Perform system/application maintenance and support activities.
  • Accountable for functional & technical requirements management.
  • Support end users for general IT related issues.
  • Develop training material and provide end user training for Viela systems as needed.
  • May perform data extraction, cleansing to enable data analytics with data from diverse sources.

Desired Skills and Experiences:

  • 1+ years experience with CRM systems.  Experience managing Veeva MediComms, PromoMats is a plus.
  • 8+ years of progressive work experience in delivering/managing information systems for pharmaceutical/biotech industry.
  • Familiarity with Mobile technology supporting field salesforce.
  • Demonstrated track record of successful Agile delivery of IT systems.
  • Experience of working with cloud platforms.
  • Experience of BI and analytics technologies. Experience of building scalable high availability analytics solutions is a plus
  • Ability to deliver with limited resource and short timeline. And able to manage multiple initiatives at once with good sense of priority setting.
  • Strong ownership and sense of urgency in responding to business needs.
  • Technical savvy with ability to quickly master a new technology and system.
  • Demonstrated technical, organizational skills.
  • 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:

  • 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)

Sr. Project Manager, Medical Affairs - Job Ref ID: 2019-058

Summary of Position

Viela Bio is looking for a talented and highly motivated Sr. Project Manager, Medical Affairs. This person will drive the Medical Affairs team towards launch excellence for all Viela Bio assets. The role will build, lead and adapt a “launch excellence model” and lead the central implementation of an integrated launch plan.

Key Responsibilities:

  • Achieve all milestones for assigned assets.
  • Ensure seamless implementation of Medical Affairs strategic plan.
  • Responsible for executing the tactics for Medical Affairs congressional presence, thought leader engagement logistics, medical advisory boards and other Medical Affairs initiatives. 
  • Vendor management and responsibility for ensuring budget is on track and properly documented. 
  • Build outstanding partnerships with all the cross-functional teams to execute a successful launch of assigned products. 
  • Stay close to external benchmark, bring improvements to optimize launch planning, implementation and processes.
  • Ensure full visibility on the launch progress of any stage; identify potential risks and coordinate risk management and solution implementation to resolve issues and remove barriers to excellent product launches.
  • Support the product launch team when influence and negotiation is required.
  • Support inspection readiness and ensure appropriate compliance policies are in place. 

Desired Skills and Experiences:

  • Minimum 2-3 years experience in pharmaceutical industry, including in Medical Affairs setting. 
  • Critical thinking & strategic decision making—ability to see big picture, identify essence through high complexity and form action in a timely fashion.
  • Strong project management /portfolio management experiences.
  • Outstanding stakeholder management skills (e.g. building partnerships, influence, negotiation, gaining commitment and driving accountability).
  • Resilience.
  • Strong interpersonal skills; ability to be flexible in varying environments and with multiple customer groups.
  • Fluent English communication in reading, written and spoken.
  • Good computer Microsoft office software skills.
  • Launch readiness experience.
  • Basic knowledge framework of all elements in product launch (clinical trial, drug registration, commercial launch and reimbursement process).
  • Flexible with business travel.
  • Good knowledge of quality systems.

Education:

  • Master’s degree in health sciences.

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

Global Publications Lead/Director - Job Ref ID: 2019-059

Summary of Position

Viela Bio is looking for a talented and highly motivated Global Publications Lead. This person will be responsible for delivering the strategic publications plan for the assigned product and indications and will lead a cross-matrix team at Viela Bio to channel our scientific capabilities to make a positive impact on changing patients’ lives.
The visibility of this role will provide opportunities for significant interactions with senior and global stakeholders in the organization as well as key external stakeholders.

Key Responsibilities:

  • Lead development/execution of the publication strategy and tactical plan for global clinical studies in humans from Phase I-IV and non-clinical trial sources, including health economics/outcomes research, epidemiology, real-world evidence (RWE), payer, and non-interventional studies, aligned with a specific medical strategy and objectives.
  • Primary accountability for medical information deliverables related to marketed and pipeline NMO products including creation and regular revision of standing response letters, FAQ documents and any required custom responses; oversees medical component of call center implementation.
  • Head the development of scientific, clinical and RWE planning data into timely publications for prescribers, payers, and patients through disease state and medicine insights; leads effective collaboration with cross-functional teams and external alliances.
  • Track existing publication plans to ensure alignment with evidence plans.
  • Day-to-day management of assigned publication plans, delivery of outputs, financial tracking and meeting activities, working closely with all members of the delivery teams.
  • Develop a thorough understanding of internal and external stakeholders to further the leverage of clinical and RWE studies.
  • Manage external agency partners to ensure accuracy of publication plan and publication deliverables with respect to time, quality and cost, and ensuring correct compliance documentation.
  • Complete multiple projects with a common deadline.

Desired Skills and Experiences:

  • Due to the importance of this product launch timing, must be experienced publications professional, ready for new challenges with creative and collaborative problem-solving skills.
  • Pre-launch and post-launch experience.
  • Ability to manage external vendors and provide clear, concise guidance.
  • Proficiency with Microsoft Office applications, and system management experience (e.g. Datavision, SharePoint, Veeva Vault, etc.).
  • Demonstrated performance, budget and resource management skills in a global organization.
  • Ability to understand and adhere to good publication practices and relevant guidelines on and scientific data communication, such as ICMJE, GPP3, company policy and SOPs.
  • Ideally possess prior experience in rare disease and/or immunology space.
  • Broad understanding of drug development process.
  • Demonstrated ability to establish and maintain professional relationships with external experts, investigators, journal editors/publishers and professional bodies publication management systems Certification as a Medical Publication Professional (CMPP) is a plus.
  • Poise in senior leader engagement.
  • Ability to prioritize, thrive and execute in high pressure situations.
  • Collaborative and consultative cross-matrix abilities.
  • Ability to appreciate and work within a large strategic framework, while maintaining strong attention to detail and compliance with global publications ethical standards, company publications policy and SOPs.

Education:

  • Relevant University Degree (BS/BA) and 8+ years of experience in publication planning/medical communications or Advanced degree in a scientific or medical discipline (e.g. PharmD, PhD, MD) and 2+ years of therapeutic area expertise

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

Director/Senior Director, Global Program Development Lead (GPL) - Job Ref ID: 2019-061

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 and Experiences:

  • 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:

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)

Clinical Supply Lead - Job Ref ID: 2019-062

Summary of Position

Viela Bio is looking for a talented and highly motivated Clinical Supply Lead. This person will be responsible for overseeing and manaing supply chain activities for multiple studies supplied globally. To maintain supply continuity, the Clinical Supply Lead will work as part of a cross functional team to develop and execute supply strategy with internal and external customers.

Key Responsibilities:

  • Oversees all aspects of clinical supply planning, capacity planning, labeling/packaging production strategy and execution, and risk management for clinical products.
  • Oversees and actively manages relationships with labeling/packaging/distribution Contract Manufacturing Organizations to ensure production and inventory targets are communicated and met.
  • Assists with study costing and contract requests and is accountable for financial tracking and reconciliation of projects.
  • Collaborates with CMC Team Leaders to ensure Drug Substance and Drug Product availability and provides forecast data for inventory maintenance.
  • Provides input and data for regulatory filings.
  • Actively communicates, collaborates with and contributes to other functional areas including Clinical Operations, Quality Assurance, CMC, and external partners and drives to achieve the best development and business results for the company.
  • Participates in the Supply Chain team and supports Commercial Supply Chain activities as required.

Desired Skills and Experiences:

  • 4+ years of relevant supply chain experience in the bio-pharmaceutical industry including supply planning, CMO oversight, and labeling and packaging.
  • Experience in Clinical Manufacturing Operations and/or Quality.
  • Broad experience in GMP operations and a proven track record of successfully leading and contributing to cross-functional teams.
  • Strong communication, interpersonal/team skills, and demonstrated strategic planning capabilities.
  • Ability to prioritize and manage multiple tasks simultaneously, to identify and resolve issues, and effectively manage timelines.

Education:

  • Bachelor’s degree in a technical or scientific discipline

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

Sr. Administrative Assistant, Finance, Business Development, CMC, Portfolio Management and Regulatory Affairs - Job Ref ID: 2019-066

Summary of Position

Viela Bio is looking for a talented and highly motivated Senior Administrative Assistant to support our growing organization’s key leadership members. This is a critical role as part of a collaborative administrative team that focuses on servicing the Finance, Business Development, CMC, Portfolio Management and Regulatory Affairs teams of the company, but also works as back up support with/for the other administrative team members. This person will require agility within a fast -paced environment.

Key Responsibilities:

  • Provide administrative support to several departments with duties that include (not limited to) managing multiple calendars to prioritize and resolve conflicts, schedule meetings, conference calls and video conferences.
  • Arrange meetings and events with internal employees as well as external contacts.
  • Book domestic and international travel.
  • File time/expense reports and supply orders with accuracy and efficiency including follow-through to ensure that appropriate and timely actions are take 
  • Coordinate departmental recruitment efforts to include scheduling of interviews, onsite assistance on the day of interview and onboarding of new employees. 
  • Produce accurate and properly formatted documents using Microsoft Office. 
  • Effectively manage special projects and other duties as assigned.
  • Help with tracking department budget.
  • Assist with coordinating legal documents for proper signatures to meet deadlines and ensure on-time delivery.

Desired Skills and Experiences:

  • At least five to seven years of related experience.
  • Good working knowledge of Microsoft Office Suite (Outlook, Word, Excel, PowerPoint, Visio).
  • Ability to use specialized equipment and maintain written records.
  • Intermediate to advanced proficiency in Microsoft Office Suite.
  • Strong written and verbal communication skills. 
  • Ability to interact confidently with employees at all levels. 
  • Able to prioritize time sensitive assignments.

Education:

Bachelor’s Degree required, preferably in Business, Finance or English.

Please click HERE to submit your resume and cover letter.

Associate Scientist II – Scientist I/Research - Job Ref ID: 2019-069

Summary of Position

Viela Bio is looking for a talented and highly motivated individual to join the research organization in a lab-based position. This person will be responsible for supporting pre-clinical programs in the areas of autoimmunity and inflammation.

Key Responsibilities:

  • Plan and coordinate laboratory activities 
  • Interact with CROs 
  • Support pre-clinical projects
  • Perform data analysis and prepare summaries of results
  • Present experimental data at team meetings
  • Maintain laboratory notebooks and records in a timely and comprehensive manner
  • Work collaboratively as part of a multifaceted research team  

Desired Skills and Experiences:

  • Experience with handling human blood and isolating cell populations
  • Proficiency with troubleshooting and developing in vitro assays 
  • Extensive background in animal models of inflammation/autoimmunity 
  • Proficiency with ELISA and ELISpot  
  • Extensive experience with multiparameter flow cytometry  
  • Background in immuno-histology a plus
  • Highly organized with experience managing several tasks simultaneously 
  • Experience in biotechnology a plus 
  • Ability to work with minimal supervision

Education:

Bachelor’s or Master’s Degree with 5+ years experience 

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

Senior Statistical Programmer - Job Ref ID: 2019-070

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 provide programming support in our clinical data analysis activities and lead the development/maintenance of the programming tools to contribute to the overall efficiency and productivity in our programming group.

Key Responsibilities:

  • Follow established standardized design and programming procedures (CDISC) to perform data manipulation, analysis and reporting of clinical trial with minimum supervision.
  • Interacts directly with Statisticians, Data Management, Clinical Development or other cross-functional teams to provide programming support and implement the appropriate data analyses.
  • Generates and validates SDTM and ADaM datasets/analysis files, Tables, Listings, and Figures.
  • Independently develops and debugs simple to complex SAS programs in a timely manner to generate and validate analysis datasets, Tables, Listings & Figures for clinical projects.
  • Reviews and provides feedback on eCRF designs, eCRF annotations, Database structures, SAPs, SPPs and data specification.
  • Develops, enhances, evaluates and validates SAS macros, utilities or modules to standardize routine clinical data analysis and reporting.
  • Communicates with vendor to ensure the overall health of the SAS platform by identifying performance and recommending/implementing tuning of active SAS environment.
  • Functions as a technical lead in developing and maintaining standard SAS Macro library, tools and platform while bringing in new ideas to improve the efficiency and productivity of the programming team.

Desired Skills and Experiences:

  • Strong SAS programming skills with Base SAS, SAS/STAT, SAS SQL and SAS Macro language; Exposure to VBA scripts, SAS/GRAPH, R, SQL, etc. a plus.
  • Statistical programming experience in the production of datasets, analyses, tabulations, graphics and listings with clinical data.
  • Experience in developing SAS Macro and utility tools with complex dataset.
  • Strong analytical, communication, teamwork, and interpersonal skills.
  • Problem-solving skills and self-motivation to work independently with minimum supervision.
  • Experience with SAS Grid, UNIX/LINUX, Shell scripting a plus.
  • Knowledge of CDISC SDTM and ADaM a plus.
  • A minimum of 3-5 years of clinical trial programming experience using SAS within pharmaceutical, biotechnology, and/or contract research organization industries.

Education:
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)

Senior Manager/Associate Director, Business Development - Job Ref ID: 2019-071

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 and Experiences:

  • 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:

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)

Notice to Recruiters:

Please contact the HR office at hr@vielabio.com in order to become an authorized vendor. All recruitment activities are managed through our HR department.

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Viela Bio is an equal opportunity employer