CAREERS

Altimmune offers exciting career opportunities and our projects are interesting and challenging. We also recruit and retain top-notch talent by encouraging innovation, recognizing achievements, and offering opportunities for advancement.

We are a talent force of innovative employees headquartered in Maryland and resourceful, decisive, and enthusiastic are common traits among our employees. We are looking for people from diverse backgrounds who share our passion for science and drive to develop novel life-saving vaccines, immune-modulating therapies, and treatments for liver diseases. Apply today via hr@altimmune.com.

Altimmune provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Regulatory Affairs Senior Manager/Associate Director

Summary of Position:

This individual will be responsible for managing operational aspects of regulatory submissions and correspondence with regulatory agencies, including document preparation and archiving. This position reports to the Head of Regulatory Affairs.

Essential Functions:

  • Manages regulatory projects as assigned and assists in the development of regulatory submission timelines and ensures execution to meet corporate goals
  • Manages the timelines and compilation of IND/CTA, BLA/NDA/MAA, Safety, and Lifecycle submissions and unscheduled safety reporting
  • Manages the preparation and submission of formal regulatory meeting requests and briefing packages and coordinates the face-to-face or online meetings with regulatory agencies.
  • Assists in the development of regulatory strategy and writing of regulatory submissions
  • Interprets FDA regulations/guidelines governing drugs, devices and biologics and advises Senior Management on pertinent regulatory intelligence.
  • Attends relevant FDA meetings and interfaces with regulatory/competent authorities, negotiating resolution of regulatory issues affecting Altimmune’s product development programs.
  • Participates in the development, review and implementation of departmental SOPs and processes.
  • Other duties as assigned.

Job Requirements (Essential knowledge, skills and attributes):

  • Operational experience in regulatory submissions management, compiling and managing eCTD submissions, and formal correspondence and liaison with regulatory agencies.
  • Thorough knowledge of GxPs and ability to interpret FDA Regulations, EU Directives, and global regulatory guidelines governing clinical development, marketing submissions, and post-approval compliance for drugs and biological products.
  • Excellent planning, organization, and project management skills including ability to adjust to rapidly changing priorities and manage multiple projects simultaneously.
  • Experience and knowledge in the preparation of global regulatory submissions (e.g., original IND/IND amendments, CTAs).
  • Must be self-motivated with a positive attitude and ability to work well with others.
  • Excellent oral and written communication skills.

Regulatory Operations Specialist

Summary of Position:

Responsible for formatting and publishing eCTD submissions to Health Authorities and building of regulatory submission deliverables ensuring submissions are of highest quality and delivered on-time. The position will also archive and track regulatory correspondences, documents and submissions.

Essential Functions:

  • Electronically formats, publishes electronic submissions, and builds Regulatory submission deliverables; ensures quality, accuracy, and submission-readiness per Regulatory agency guidance and specifications, and internal procedures.
  • Archive (categorizing and classifying information) all Regulatory records pertaining to multiple Regulatory Applications (e.g., IND, BLA, CTA), and maintaining Regulatory Application indexes, tracking of regulatory submission documents, and special projects as needed.
  • Supports regulatory projects as assigned and assists in the development of regulatory submission timelines and ensures execution to meet corporate goals.
  • Participates in the development, review and implementation of departmental SOPs and processes.

Job Requirements (Essential knowledge, skills and attributes):

  • Experience submitting through FDA’s ESG
  • Good understanding of applicable FDA and ICH guidelines related to regulatory submissions
  • Good understanding of eCTD publishing systems, EDMS technology and authoring tools and templates.
  • Clear understanding of regulatory submission content and format requirements
  • Experienced in lifecycle management eCTD submissions including but not limited to, IND Safety, and IND Investigator submissions
  • Skilled in ISI Toolbox, Adobe Acrobat DC, Lorenz Validation
  • Can work independently, ability to multitask, self-motivated, well organized, detail oriented, able to prioritize, works effectively under pressure, and has excellent written and verbal communication skills.

Education/Training/Experience:

  • Bachelor’s Degree
  • 3-5 years of experience

Executive/Senior Director, Vaccine Clinical Development

Summary of Position:

To address Altimmune’s increasing clinical needs, the Company is seeking an Executive/Senior Director, Vaccine Clinical Development to drive the clinical research strategy across the portfolio of vaccine candidates. This position will report to the CMO and will oversee the clinical development of Altimmune’s pipeline vaccines. The Executive/Senior Director, Vaccine Clinical Development will also play an important role in business development activities. S/he will be expected to ensure that all programs meet quality and safety standards required by the medical community and regulatory agencies. The ideal candidate will be able to operate both at a high strategic level and execute at a tactical level with ease.

Essential Functions:

  • Assist in the development of Altimmune’s clinical research strategy for vaccine candidates across preclinical development, clinical research, manufacturing and regulatory affairs.
  • Develop clinical trial protocols, investigator brochures, and other documents required to conduct clinical trials.
  • Oversee management of clinical trials including investigator selection, analysis of patient recruitment strategies, milestones, coordination of lab samples, data collection and analysis.
  • Support business development activities involving in-licensing, out-licensing and solicitation of government awards.
  • Represent Altimmune’s clinical and medical strategy to internal and external stakeholders including the Board of Directors and investors.
  • Manage internal and external resources to ensure clinical research plans are executed on time and within budget.
  • Identify suitable clinical trial sites and develop effective working relationships with clinical investigators and thought leaders.
  • Oversee safety, including the review of SAEs and safety data; ensure that sites and regulatory agencies are notified, and all company and regulatory procedures are compliant.
  • Manage CRO’s; including identifying suitable partners, defining CRO responsibilities, communication plan, divisions of responsibility, milestones, contracts, reviewing monthly status reports, and maintaining interactive management to ensure project success.
  • Oversee regulatory filings, including drafting, editing and preparing of routine correspondence and sections of INDs, BLAs, NDA’s, Annual Reports, Amendments, Supplements, Orphan Drug Applications and other regulatory submissions.
  • Oversee development and maintenance of clinical SOPs related to GCP activities.
  • Ensure that all of Altimmune’s drug and vaccine clinical programs are conducted in accordance with Good Clinical Practice (GCP), ICH guidelines and all applicable regulatory requirements.

Job Requirements (Essential knowledge, skills and attributes):

  • Medical degree/MD
  • Minimum seven (7) years in vaccine clinical research experience, preferably in the field of viral vaccines; phase 1-3 clinical trials; prior experience in viral vaccine business development experience activity desired
  • Knowledgeable in medicine and pharmaceutical product safety
  • Experience applying medical knowledge to the interpretation of individual case review

Senior Director/Vice President, Finance

Summary of Position:

Reporting to the CFO, this senior-level finance and accounting position has responsibility for corporate, functional, and program level strategic planning, budgeting and financial analysis models used for managing corporate resources. Leads the overall budgeting and forecasting process at functional, program and corporate levels.

Essential Functions:

  • Financial Reporting, Analysis, Budgeting & Forecasting – The Vice President of Finance will be asked to develop and lead the financial planning process and work closely with the functional leaders to develop an annual budget, setup baseline expectations, perform quarterly forecasts, variance analysis presentations and reviews. The Vice President of Finance will perform a variance analysis each month and prepare a formal analysis for the senior management team.
  • Business Case Analysis and Decision Support – The Vice President of Finance will act as a financial business partner to the functional leaders. The Vice President of Finance will develop financial models to assist these executives in making informed business decisions.
  • Metrics Reporting – The Vice President of Finance will be responsible for developing and providing an analysis of key performance measurements. As part of this process, the vice president of finance will be expected to ensure that important and relevant metrics are being measured and analyzed.
  • Strategic Planning – The Vice President of Finance will support the chief financial officer to develop and implement the corporate strategy for the Company. This position will identify existing operational and new business opportunities including market development, investment prioritization, mergers & acquisitions and additional organic growth opportunities. The Vice President of Finance will monitor external factors including market forces, macro/microeconomic trends and various competitive implications. This person will lead a rigorous, data-driven analysis, which will diagnose the current state and model future outcomes for business performance
  • Additional Responsibilities – The Vice President of Finance is responsible for supporting the data and business intelligence needs of the Company. This person will ensure the cross functional leaders have the information and reporting tools needed to support their business processes and be a partner in driving change within the organization as required.

Job Requirements (Essential knowledge, skills and attributes):

  • Team player with an ability to work collaboratively and ability to develop productive relationships with key stakeholders across the organization and externally
  • Prior work experience in Corporate FP&A and Big 4 accounting /consulting strongly preferred
  • Biotech/pharma industry experience required
  • Government contracting experience strongly preferred
  • Experience building complex financial models
  • Strong leadership skills with the ability to operate strategically at a highly level- must be able to see connections between financials/data and business drivers, and draw strategic and operational insights from the performance of the business
  • Advanced Excel and PowerPoint proficiency
  • Strong oral and written presentation skills – ability to present to executive audiences
  • Prior experience customizing financial reporting in an ERP system preferred
  • Exceptional attention to detail
  • Strong organizational skills and ability to prioritize work and multitask to meet deadlines
  • Outstanding time management skills and accountability

Education/Training/Experience:

  • 10+ years of experience in finance leadership, analytical role requiring Excel model building and analysis
  • BA/BS degree or equivalent required
  • CPA and/or MBA degree preferred

Senior Clinical Trial Manager

Summary of Position:

Senior Clinical Trial Manager plays an important part in the clinical trial process. The CTM position will perform a wide variety of activities to lead the startup and completion of clinical research studies and may supervise and/or mentor other clinical operations personnel, including Clinical Trial Manager(s).

Essential Functions:

  • Leads in creating and managing the study project plan, including timeline, vendors, budget, and resources
  • Ensures assigned study objectives are achieved by working with all stakeholders to set project priorities and milestones and resolve project conflicts from concept through final CSR
  • Develops and tracks study timelines and quality metrics
  • Ensures GCP and regulatory compliance is maintained through creation and management of CQP with Altimmune Quality group
  • Leads in the development of study-related documents, including study protocols, informed consent documents, study manuals and plans, trial master files, case report form design, etc.
  • Leads in the logistics of IP, clinical lab samples and ancillary supply shipments
  • Maintains professional expertise through familiarity with therapeutic areas
  • Manages, mentors, and develops direct reports, including Clinical Trial Managers
  • Attends regularly scheduled cross-functional study team meetings with internal and external resources, CROs and site staff
  • Leads and/or participates in CRO and other vendor selection and management
  • Participates in meetings with investigative sites, key opinion leaders and consultants as needed
  • Proactively identifies and resolves issues, and participates in process improvement initiatives as required
  • Responds promptly and appropriately to study questions and issues raised by investigative sites, vendors, monitors, and consultants
  • Manages clinical monitoring activities ensuring compliance with Good Clinical Practices (GCP) and applicable regulations
  • Reviews serious adverse events and other pertinent data with the medical monitor and drug safety personnel to identify safety trends and potential risks
  • Ensures the ongoing compilation and reconciliation of the Trial Master File

Job Requirements (Essential knowledge, skills and attributes):

  • 10 years clinical research experience in an industry setting and a minimum of 5 years project-lead or management experience
  • Bachelor’s and/or master’s degree in a scientific discipline, RN, BSN degree or equivalent
  • Conscientious, influential person with an outstanding work ethic and strong personal discipline
  • CRA certification (ACRP or equivalent) is strongly preferred
  • Excellent organizational, leadership and problem-solving skills
  • Excellent written and verbal communication skills
  • Experience in leading cross-functional teams to meet goals and metrics
  • Know-how in managing Phase I, II, & III clinical studies
  • Experience in writing clinical study protocols, informed consent forms, and other clinical documents
  • Solid understanding of FDA and other regulatory requirements that may impact global clinical studies
  • Thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management
  • Willing and capable to manage multiple projects, negotiate budgets, timelines and responsibilities
  • Working knowledge of SmartSheet, MS Project or similar software for the development and update of clinical study timelines
  • Track and manage contracts and budgets for assigned clinical trials