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.

Clinical Data Manager (DM) - Job Ref ID: 2019-006

Summary of Position

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

Key Responsibilities:

  • Serves as an expert in end-to-end CDM, providing oversight and advice to the clinical project team regarding CDM activities and deliverables
  • Manages and resolves issues related to CDM deliverables by developing solutions to complex problems
  • Develops clinical project standards and processes based on industry best practices
  • Reviews, assesses and manages CRO delivery against KPIs and overall DMC performance
  • Manages external data processes, including setup and reconciliation
  • Other duties as assigned

Desired Skills and Experiences:

  • Minimum of 5 years of Data Management experience in the Biotech/Pharma/CRO industry
  • Demonstrated knowledge of drug development process
  • Demonstrated current understanding of GCP and regulatory requirements as they relate to data management systems and activities, and Good Clinical Data Management Practices
  • State-of-the-art understanding of database structures and data standards (CDISC)
  • Experience with clinical data management systems and electronic data capture (EDC)
  • Excellent verbal and written communication skills. Strong leadership skills. Excels at making good decisions and priority setting.

Education and Minimal Requirement

  • Education: Minimum of a BS in life sciences degree and/or equivalent experience
  • CCDM preferred

Please click HERE to submit your resume and cover letter.

Project Coordinator, Project Management - Job Ref ID: 2019-009

Summary of Position

The Project Coordinator, Project Management reports through the Senior Director, Project Management. In this position the individual ensures successful coordination of activities to support the R&D cross-functional teams in the delivery of drug projects which advance treatments for those suffering from severe inflammation and autoimmune diseases.

Key Responsibilities:

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Works closely with project management leadership
  • Coordinates with the project manager for tracking of project milestones, schedules, and timelines
  • Manages the flow of information contained in project and portfolio systems such as Sharepoint and MS Project
  • Collaborates with cross-functional team members to compile the monthly reports and dashboards regarding status of project milestones
  • Assists in scheduling meetings, preparation of agendas and minutes
  • Other duties as assigned

Desired Skills and Experiences:

  • Two to Four (2-4) years of experience in pharma/biotech
  • Effective communication skills
  • Experience with project management software (Excel, PowerPoint, Sharepoint, MS Project)

Education and Minimal Requirement:

  • Bachelor’s degree; concentration in a scientific-related discipline required

Please click HERE to submit your resume and cover letter.

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.

Senior Director, Hub/Patient Services - Job Ref ID: 2019-013

Summary of Position

Viela Bio is looking for a talented and highly motivated Senior Director, HUB/Patient Services. This person will be responsible will lead the day-to-day operations of Viela Bio’s reimbursement case specialists and patient service teams. 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 will develop HUB and co-pay assistance strategy, lead the selection and contracting of service providers, manage all contracted reimbursement and customer service operations and support a culture of transparency, collaboration and growth.

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 in compliance with all laws, regulations and policies and demonstrate Company values.

Desired Skills and Experiences:

  • 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 vendors providing services intended to improve patient experience
  • Travel: as needed

Education:

  • 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.

Manager, Payroll and Equity Administration - Job Ref ID: 2019-026

Summary of Position

Viela Bio is looking for a talented and highly motivated Payroll/Stock Plan Manager. This person will oversee all aspects of grants and releases, as well as Payroll administration.

Key Responsibilities:

  • manage payroll / payroll reporting as well as all RSU grants, releases and ESPP purchases and financial accounting
  • maintain electronic database of all equity agreements and accurate statuses 
  • Section 16 monitoring for officers and BOD members (Forms 3, 4, 5) 
  • prepare related SEC filings for stock compensation 
  • support payroll and stock plan related audits 

Desired Skills and Experiences:

  • 5+ years related experience; must include stock plan experience
  • strong accounting and reporting skills; accrual methodology; detail oriented 
  • SOX compliance experience 
  • I-solved/Ultipro
  • Oracle financials preferred, Equity Edge Online 

Education:

  • Bachelor’s degree in Finance or Accounting preferred

Please click HERE to submit your resume and cover letter.

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.

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.

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.

Business Development Search and Evaluation Analyst/Manager - Job Ref ID: 2019-038

Summary of Position

Viela Bio is looking for a talented and highly motivated Business Development Search and Evaluation Analyst/ Manager. This role will play a key role in identifying scientific innovation related to immunology and inflammation across academia and biotechnology that compliments Viela Bio’s drug development pipeline and R&D strategy.

Key Responsibilities:

  • Identify high-impact science across academic centers and biotechnology companies. 
  • Accountable for covering the external landscapeproactively source, evaluate, and prioritize scientific partnering opportunities and bring them forward for internal decision-making.
  • Identify relevant companies and academic programs (based on scientific or other capabilities) by developing and leveraging personal scientific network, conferences and publications. 
  • Ensure that strong relationships are established and maintained in areas of interest to Viela Bio strategy.
  • Facilitate scientific evaluations by leading or supporting cross-functional efforts that may include other Viela Bio business units (e.g., Research, Clinical, Regulatory, CMC, Commercial, Legal, Finance).
  • Develop and maintain business relationships with key external collaborators in the academic, research, biotechnology, pharmaceutical and venture communities. 
  • Support preparation of presentation materials, reports, and updates for senior management briefings. 
  • Support negotiation of complex/sensitive alliances.
  • Work closely with the Research and Clinical teams to understand and align on research strategy and direction. 

Desired Skills and Experiences:

  • Strong scientific background and pre-clinical/clinical drug development knowledge and/or experience.
  • PhD in a relevant Life Sciences discipline.
  • 2+ years work experience in biopharma or a life-sciences related field  
  • Strong understanding of immunology, understanding of biotechnology drug development a plus.  
  • Strong publication record.
  • Experience in business developmentlicensing, or venture capital a plus.
  • Creative thinker with ability to see opportunities where others may not.
  • Strong networking skills.
  • Therapeutic area network in the biopharma industry or academia a plus. 
  • Strong written and oral communication skills. 
  • Strong organizational abilities with keen attention to detail and high level of self-motivation 
  • High level of self-motivation. 

Education:

  • PhD, or equivalent

Travel:

  • Domestic and international travel required (estimated 25%)

Please click HERE to submit your resume and cover letter.

Senior Quality Specialist - Job Ref ID: 2019-039

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 party vendors, Research, Development, CMC, Commercial and Clinical 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; Implementing and utilizing Quality Management; Product release utilizing systematic process flows; training and documentation management. Review documents such as SOPs, deviations, change control requests, corrective and preventive action plans, validation protocols/reports, technical reports, etc. Interprets and implements regulations into quality procedures 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 and Experiences:

  • Minimum of 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 in 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:

  • B.S. in Biology, Chemistry, Engineering or related fields preferred.

Please click HERE to submit your resume and cover letter.

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.

Director, Reimbursement, Access and Value - Job Ref ID: 2019-057

Summary of Position

Viela Bio is looking for a talented and highly motivated Director of Reimbursement, Access and Value. This person will be responsible for providing on-site and on-demand education for reimbursement challenges and support services that are available. This position is field based.

Key Responsibilities:

  • The Director, Reimbursement is responsible for supporting Market Access, Reimbursement and Patient services by providing assistance with reimbursement challenges.   
  • This position is client-facing and customer-facing and requires the ability to build relationships to effectively deliver services.  
  • The Director, Reimbursement 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. 
  • This individual must have a solid working knowledge of Medicare and Commercial insurance plans and benefit structures to be able to relay detailed benefit information and maximize the customer experience. 
  • This position reports to, and works closely with, the Senior Director, Reimbursement, Value and Access to advance our company’s culture of patient-centricity and to build internal capabilities that support the vision of Viela Bio. 
  • They will be required to work closely with other members of the commercial team, including marketing, sales, trade, and sales operations, as well as other cross-functional partners. 
  • Reimbursement Support includes:
    • Billing and coding updates
    • Appropriate claims submission
    • Specialty Pharmacy
    • Medical Benefit Interpretation
    • Understanding medical necessity
    • Claims / Appeal assistance
    • Information related to co-pay and patient assistance programs 
  • Educating includes:
    • Billing and coding updates
    • Appropriate claims submission
    • Specialty Pharmacy
    • Medical Benefit Interpretation
    • Understanding medical necessity
    • Claims / Appeal assistance
    • Information related to co-pay and patient assistance programs 

Desired Skills and Experiences:

  • Minimum of 8 years of pharmaceutical and/or biotech experience required in market access, reimbursement, or related functions.
  • Minimum of 7 years of experience in reimbursement for medical benefit products required with a significant focus on interacting with CMS and other government / commercial payers.
  • Must have proficiency with Outlook calendar, Word, PowerPoint, and SharePoint, and a general facility for information technology and for learning new software.
  • Will need to travel in support of objectives.

Education:

  • Bachelor’s degree in life science and/or business.

Please click HERE to submit your resume and cover letter.

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.

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.

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.

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