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. If you are interested, please submit your resume and cover letter to hr@vielabio.com. We will reach out to you should your experience and interests align with our needs.

Associate Director/Director, Formulation Development

Summary of Position

Viela Bio is looking for a highly motivated, entrepreneurial individual to lead formulation development with partners and CDMOs to advance Viela’s portfolio.

Key Responsibilities:

  • Work with partners and CDMOs and drive end-to-end formulation/presentation development, from early molecule selection, to advance clinical studies, as well as intended commercial formulations and container closure/packaging systems.
  • Review/approve formulation development, characterization, risk assessment, and control strategy reports.
  • Plan, lead/support Drug Product technology transfer to meet agreed objectives, timelines and budgets.
  • Review/approve drug product relevant portions of regulatory applications (IND, INDa, IMPD, CTA, BLA/MAA) and response to agency questions.
  • Lead CMC teams.

Desired Skills and Experiences:

  • Significant in-depth technical expertise in formulation of biologics. Extensive knowledge in protein biophysics and biochemistry, intermolecular interactions, degradation mechanisms, surface science, and primary container technologies for biologics use such as prefilled syringes, IV bag technologies, etc.
  • Demonstrated scientific expert in high concentration liquid formulation development of monoclonal antibodies, bispecific mAbs, fusion proteins. Knowledge in cellular and gene therapies is desired.
  • Experience with late stage formulation characterization, control strategy, quality risk management, and marketing applications is desired.
  • Knowledge and experience with device development, combination product development desired.
  • Proven success record in managing third-party CMOs and Drug Product technology transfer.
  • Familiarity in developing lyophilized products through the full development lifecycle.
  • Experienced with regulatory submissions and Regulator Agency interactions.
  • Prior experience in leading cross functional CMC teams preferred.
  • Excellent verbal and written communication skills. Strong leadership skills. Excels at making good decisions and priority setting.

Education and Minimal Requirement

PhD in Biochemistry or Chemical Engineering or related field with 7+ years of biotechnology experience.

Senior Scientist/Principal Scientist, Analytical Sciences

Summary of Position

Viela Bio is looking for a highly motivated, entrepreneurial individual to lead analytical development with partners and CDMOs to advance Viela’s portfolio.

Key Responsibilities:

  • Work with partners and CDMOs to develop and optimize HPLC, CE, mass spectrometry and other protein analytical methods to support early molecule selection, advance clinical trial and product license application.
  • Serve as the subject matter expert for molecule developability, product characterization, CQA assessment, method issues, including experiment design, data interpretation, and troubleshooting. Contribute to the investigation and resolution of out-of-specification (OOS) and out-of-trend (OOT) testing results.
  • Review characterization plan/reports, comparability protocol/reports, method SOPs, method development/transfer/qualification and validation protocols and reports.
  • Lead preparation and review of CMC sections related to analytical procedures, method validation, comparability, specifications, reference standard and stability in INDs, IMPDs, MAAs, BLAs, and other regulatory submissions.

Desired Skills and Experiences:

  • Significant in-depth technical expertise in analytical development and commercialization of biologics. Broad knowledge of protein chemistry and structural characterization of mAbs and novel biologics using various analytical techniques. Experience with regulatory submissions and Regulator Agency interactions.
  • Demonstrated scientific expertise in mass spectrometry, HPLC (SEC-,RP-,IEX-,HIC-), electrophoresis (CE-SDS, icIEF), and glycan analysis. Familiarity with biophysical tools such as FTIR, DSC, CD and AUC. Knowledge with bioassay and binding assay development is a plus.
  • Experience in cGMP (such as document management, deviation root-cause analysis, CAPA and change control) and QC practices including reference standard, control chart, stability, IOQ and validation.
  • Prior experience in leading analytical development required. Proven success record managing third-party CMOs and analytical method transfer required.
  • Experience with late stage characterization, CQA assessment, control strategy, and marketing applications desired.
  • Excellent verbal and written communication skills. Strong leadership skills. Excels at making good decisions and priority setting.

Education and Minimal Requirement

PhD in Biochemistry or related field with 5+ years of biotechnology experience.

Clinician, Director

Summary of Position

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

Key Responsibilities:

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

Desired Skills and Experiences:

  • 5 plus years in clinical research and/or drug development in CRO, pharmaceutical environment, or academia.
  • Good understanding of the drug development process (especially early phase clinical trials), protocol writing & study conduct, data review and reconciliation, the principles of translational medicine, and what it takes to lead teams successfully.

Education and Minimal Requirement

MD with a valid US medical license preferred; Medical specialty and sub-specialty training in an area related to autoimmune diseases required.

Manager/Sr. Manager of Clinical Operations

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 and Minimal Requirement

BS preferred.

Associate Director, Clinical Operations

Summary of Position

Viela Bio is looking for a talented and highly motivated Associate Director (AD) of Clinical Operations. This is a position requiring solid understanding of all aspects of industry sponsored clinical trials Phases 1-3. 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 expert clinical operational input into Clinical Development Plan (CDP), Protocol Concept Sheet (PCS), Clinical Study Protocol (CSP), and Clinical Study Report (CSR).
  • Deliver differentiated and robust operational design options for review at governance interactions.
  • Define and manage accountabilities for all CTT members
  • Oversee and approve selection of vendors for trial support.
  • Serve on vendor governance bodies. Establish and track key performance indicators.
  • Coordinate with Clinical Quality Assurance for activities associated with regulatory inspections and audits.
  • Participate in BLA submission activities.
  • Responsible for the initial forecasting and management of all clinical trial related costs.
  • Lead process improvement initiatives.
  • Create operational plans and SOPs.
  • Hiring and line management of Senior Manager, Clinical Operations / Manager, Clinical Operations / Project Coordinator, Clinical Operations roles.
  • Work with direct reports to create yearly operational goals and long term individual development plans.

Desired Skills and Experiences:

  • Strong leadership and communications skills including the ability to engage with diverse internal and external collaborators and manage through conflict.
  • Strategic skills including a high level of creativity, innovation, and problem solving.
  • Thorough understanding of country level regulations, ICH, and GCP guidelines.
  • Thorough understanding of cross-functional clinical deliverables including data management, biostatistics, medical writing, drug safety, CMC, and regulatory affairs.
  • Line management experience.
  • Minimum of twelve years of experience in the pharmaceutical/biotech industry.
  • Minimum of eight years in clinical operations project management/leadership positions.
  • Preferred global program level experience across the product life cycle and in multiple therapeutic areas.
  • Ability and willingness to travel occasionally (internationally and domestically).

Education and Minimal Requirement

  • Bachelor of Science preferable in medical biological science, business, project management or finance.
  • Advanced degree is preferred.

Scientist II

Summary of Position

The Scientist II will support research activities in regard to clinical trial progression of drugs that target the immune system for autoimmune indications. The candidate will be expected to analyze, interpret and present data sets and should have a clear and effective presentation skills and be able to work independently with minimal supervision.

Education and Minimal Requirement

PhD with post doctorial experience in immunology or related field with 2-5 years experience in industry.

Preferred Skills/Qualifications:

  • In depth knowledge of adaptive and innate immunity required.
  • Extensive background in multi-color cytometry panels required.
  • Extensive experience handling human blood and isolation of lymphocyte subsets required.
  • Extensive experience with design and execution of ELISA and ELIspot and other proteomics assays required.
  • Preparation of RNA, designing primers and running RTpcr required.
  • Established publication record required.
  • Analysis of “big data” transcriptomics and proteomics a plus.
  • Previous experience working on translational aspects of clinical design a plus.

Manager/Senior Manager, Regulatory Affairs

Summary of Position

Viela Bio is seeking a talented and highly motivated Manager/Senior Manager Regulatory Affairs. This person will be responsible for supporting the Head of Regulatory Affairs and Senior Director, Regulatory Chemistry Manufacturing and Controls (CMC) in the execution of the regulatory strategy for the Viela Bio product portfolio.

Key Responsibilities:

Manager

The Manager, Regulatory Affairs reports to the Senior Director of Regulatory Affairs and provides support for specific development programs and products. Participates in the planning of regulatory submissions and related activities. This is a hands-on position. Works under supervision.

  • Plans and coordinates regulatory submissions assuring completeness and quality of submissions; identifies issues, suggests and implements solutions.
  • Prepares regulatory files for electronic submission and oversees editing and publishing of final submissions to meet regulatory requirements; develops or revises regulatory templates, processes and procedures to ensure compliance with regulations.
  • Provides regulatory support for Clinical Operations, Research, and Translational Science teams.
  • Conducts regulatory review of clinical documents, including: protocols, informed consent, and clinical study reports.
  • Researches, reviews, and interprets related product approvals, current regulatory guidance documents and recent public Advisory Committee proceedings, to support the development of optimal regulatory strategies.
  • May communicate with regulatory agencies regarding submissions.
  • Interacts with company partners and consultants for various regulatory matters as needed.

Senior Manager

The Senior Manager, 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.

  • 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.
  • Identify potential regulatory risks and apprise the team and supervisor as appropriate.
  • Provides regulatory support for Clinical Operations, Research, and Translational Science teams.
  • 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.
  • Prepare components of regulatory submissions to FDA and other agencies with minimal direction from the Senior Director of Regulatory Affairs or Regulatory Affairs CMC.
  • May communicate with regulatory agencies regarding submissions.
  • Interacts with company partners and consultants for various regulatory matters as needed.

Desired Skills and Experiences:

Manager

  • Knowledgeable of pharmaceutical guidance documents, regulations, drug development process, and industry standard practices.
  • Ability to work in close collaboration with colleagues in regulatory department and throughout the organization.
  • Experience interacting with CROs in the management of US eCTD IND submissions and ex-US CTAs towards clinical trial activations is a plus.
  • Proficient user of standard MS Office suite (eg, Word, Excel), experience using electronic document management systems and document review tools desirable.
  • High attention to detail; ability to organize and prioritize assigned projects.

Senior Manager

  • 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.
  • Excellent organizational and communication skills.
  • Good interpersonal skills and desire to work in a team environment.
  • Strong independent research capabilities using available paper and electronic resources.
  • Proficient user of standard MS Office suite (eg, Word, Excel), experience using electronic document management systems and document review tools required.

Education and Minimal Requirement:

Manager
BA/BS in life sciences or a relevant discipline with at least 2 years of experience in a regulatory affairs function in a biopharmaceutical company; or related coursework.

Senior Manager

Advanced degree in life science or Regulatory Affairs preferred with at least 4-8 years of RAC certification strongly preferred.

Medical Affairs Leader

Summary of Position

The Medical Affairs Lead is responsible for the overall MA strategy during preparation for launch, during launch and post launch. MAL will work closely with the commercial lead to develop the processes and allocated the resources to support such strategy. MAL will provide guidance and support to the MSL lead and team in executing the strategic plan. The MAL will have a leadership role in the multidisciplinary team of Viela bio and will work closely with the CD Leads, CMO, Regulatory, legal and commercial.

Key Responsibilities:

  • Develop the strategic plan for Medical Affairs team.
  • Develop the syllabus for MSLs.
  • Develop a comprehensive plan for engagement with US experts in disease area.
  • Develop strategic plan for MA cover of all US territory.
  • Lead and manage effective relationships with US Key Opinion Leaders.
  • Ensure appropriate allocation of resources across the Viela Bio brands and pipeline, in line with corporate strategies and priorities.
  • Network extensively to develop long-term strategic partnerships with thought leaders both internally and externally.
  • Represent Viela Bio at medical meetings, advisory boards and outreach meetings as needed/appropriate.
  • Contribute to and collaborate with clinical development with regards to ongoing or planned interventional clinical trials (phase 1-4) as needed.
  • Develop a strategy for approval and managing investigator-initiated studies.

Desired Skills and Experiences:

  • At least 5 years of successful academic work in medical discipline related to immunology plus 5 years industry experience in MA in disease area related to immunology including rare diseases. Product launching experience is desirable.
  • Solid personal and professional relationships with key opinion leaders (KOLs) in medical areas related to immunology.
  • Strong credibility within the US medical community which includes the ability to reach out to key thought leaders in academia.
  • Strong working knowledge of the clinical drug development process in the USA.
  • Strong skills and experience in analyzing and presenting complex clinical data.
  • Strong understanding and experience in the regulatory guidelines governing MA.
  • Track record in the conduct/participation in clinical trials (investigator initiated, company sponsored or cooperative group trials) and their subsequent publications.
  • Experience managing and leading MSL teams.

Education and Minimal Requirement:

MD or DO with board certification and /or board eligibility in medical discipline related to immunology. US State Licensure to practice medicine is desirable.

Medical Science Liaison

Summary of Position

As a member of our field-based team, this position will function as an extension of the Medical Affairs organization and will be responsible for developing and managing professional relationships with medical thought leaders involved in various stages of product development and medical organizations including treatment centers, established societies and associates. This position provides medical information through scientific exchange and supports the company’s scientific and clinical needs.

Key Responsibilities:

  • Develop Strong relationships and scientific partnership with key scientific centers and key external experts.
  • Scientifically engage with high priority HCPs and patient advocacy group pre and post launch.
  • Deliver clinical/scientific information to varied audiences with effect.
  • Support community affairs and general program engagement.
  • Creation of materials – reports, presentation, etc.
  • Approximately 50-60% travel is required in assigned region.
  • Supporting payer access/present clinically.

Desired Skills and Experiences:

  • 5 years of MSL experience in autoimmune or rare disease area preferred.
  • Strong leadership skills.
  • Outstanding strategic thinking, problem-solving/innovative/creative.
  • Organizational and communication skills both internally and to external partners.
  • Team builder.
  • Time and territory management skills.

Education and Minimal Requirement:

PharmD or PhD preferred.

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.

Contact Us

Viela Bio is an equal opportunity employer