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.

Quality Assurance Specialist

Summary of Position:

The Quality Assurance Specialist is responsible for quality support for all activities related to the manufacture and testing of products through all phases of the clinical lifecycle. The selected candidate will have a detailed understanding of manufacturing processes, tech transfer, analytical, quality systems and GMP/GLP requirements. The essential duties will be to support product disposition, clinical trial material disposition, product testing, investigations, change control, risk assessments and quality systems. The candidate will help to create a quality-oriented culture throughout the organization.

Essential Functions:

  • Manage lot review activities for clinical material/products to ensure disposition timelines are met.
  • Review and manage deviations from contractors related to manufacturing and testing.
  • Review executed batch production records to ensure compliance with approved procedures, quality agreements and GMP/GLP expectations.
  • Communicate and resolve discrepancies with CMOs/CTLs.
  • Compile and manage lot files.
  • Assist in the preparation, execution, report and follow-up of internal and external audits.
  • Participate in quality system improvements.
  • Monitor project progress to ensure efficient and effective communication on project status and issues.
  • Author, review and revise site SOPs to ensure compliance with GDPs, regulatory requirements and corporate standards.
  • Perform other duties as assigned by Quality Management

Job Requirements (Essential knowledge, skills and attributes):

  • Bachelor of Science degree or higher in a scientific discipline is required.
  • A minimum of 5 (five) years of GMP quality assurance experience in biopharmaceutical industry is required.
  • Demonstrate a solid understanding of biologics manufacturing – process, analytical operations, quality systems and regulations.
  • Direct experience with document management, SOP development, batch record review and product disposition are required.
  • Experience in GMP/GLP record review, investigations, change control, validation and risk assessment.
  • Ability to build strong collaborative relationships with partners in and outside of the organization.
  • Excellent communication and interpersonal skills for effectively interfacing with internal and external personnel at all levels.
  • Ability to manage competing priorities and timelines in a fast-paced, rapid-growth environment.
  • Excellent problem-solver with the ability to work independently.
  • Experience with providing direct oversight and support to clinical material manufacturing operations is highly preferred.
  • Experience performing deviation investigations including CAPA planning and management is highly preferred.
  • Excellent attention to detail.
  • Proficient use of MS PowerPoint, Excel and Word.
  • Occasional travel up to 5-10% of time.
  • Experience performing Quality audits, a plus.

Associate Director, Clinical Operations

Summary of Position:

The Associate Director (AD), Clinical Operations is responsible for assisting in the strategic planning, oversight and execution of all clinical trials across programs. The AD of Clinical Operations may also directly manage studies. Responsibilities include creating timelines and budgets, overseeing day-to-day operations, ensuring studies are conducted in accordance with regulatory requirements and within established timelines and budgets. Additionally, the AD of Clinical Operations will be responsible for leading cross-functional teams and managing relationships with investigator sites, vendors and consultants. The AD of Clinical Operations will assist in departmental process improvement initiatives. The AD of Clinical Operations may supervise Clinical Trial Managers, CRAs and other clinical support staff.

Essential Functions:

  • Lead/participate in program strategy meetings and contribute to the operational strategy of responsible program/studies.
  • Responsible for the selection and oversight of external service providers, including CROs and other vendors as necessary.
  • Serve as an escalation point for Clinical Trial Managers, CRAs, or other support staff
  • Develops and manages clinical trial budgets, providing ongoing financial reporting
  • Leads/participates in vendor/site budget negotiations and assists with Clinical Trial Agreements as necessary
  • Manages responsible study(ies) within agreed timelines and budget and in accordance with internal SOP’s and GCPs
  • Coordinates cross functional efforts to achieve study objectives and goals.
  • Identifies and communicates study issues that will impact budget, resources and timelines.
  • Provides support/escalation point for study team leads as needed.
  • Establishes and maintains relationships with assigned investigator sites, vendors and consultants.
  • Prepares potential investigator site lists and assists with their evaluation for inclusion in the study, ensuring proper prequalification of clinical sites.
  • Participates in the preparation, review and finalization of clinical study-related documents such as protocols, protocol amendments, Clinical Study Reports (CSRs), regulatory submissions, and other publications as required.
  • Ensures documentation prepared internally or by CRO(s) is completed in accordance with GCP regulatory requirements and consistent with the protocol for assigned studies/programs.
  • Participates in the ongoing and final review of clinical study data to ensure the data is accurate and complete, and assessment of the impact of this data to the study and program.
  • Ensures Trial Master File is accurate and up to date
  • Mentors more junior team members.
  • Leads department initiatives and assists in the design and implementation of standardized work processes.

Job Requirements (Essential knowledge, skills and attributes):

  • 10+ years clinical research experience in an industry setting and a minimum of 7 years project-lead or management experience
  • Previous experience managing clinical operations staff across multiple programs, including global experience
  • Bachelor’s and/or master’s degree in a scientific discipline, RN, BSN degree or equivalent
  • Interpersonal Skills – Must have strong leadership abilities and the communication and interpersonal skills needed to influence decision-making in a diplomatic manner. Demonstrated effective team leadership in cross-functional matrix teams.
  • Communication Skills – Excellent oral and written communications with ability to present data to all levels of audiences.
  • Productivity/Organizing/Planning – Meets deadlines, demonstrates effective use of time, and handles multiple assignments simultaneously. Ability to proactively identify and take appropriate initiatives to fulfil the requirements of the role. Ability to maintain a high level of productivity with minimal supervision.
  • Strategic Thinking – Strong capability of strategic thinking and proposing innovative solutions to issues.
  • Collaboration & Teamwork – Advanced competence in collaboration & teamwork, communications, influence, conflict resolution, strategic agility, planning & organizing, team building, driving results and problem solving.
  • 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 MS Project for development and update of clinical study timelines
  • Vaccine experience highly 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

Associate Scientific Director

Summary of Position:

The Associate Scientific Director is responsible for providing scientific, research, and educational support to the Chief Scientific Officer and internal business development efforts related to the current and future Altimmune products. The Associate Scientific Director will work collaboratively with other key departments in the organization, presenting data trends and results to create appropriate actions as needed. The Associate Scientific Director provides scientific vision, content and context to the organization’s operations. The Associate Scientific Director will develop innovative scientific research, preclinical and clinical strategies to support and drive the business forward.

Essential Functions:

  • Foster an environment of innovative thinking.
  • Serve as the principal advisor on scientific affairs to the CSO.
  • Develop and maintain detailed knowledge of assigned therapeutic area(s), client and competitor product(s), the compliance/regulatory environment, and international standards for disclosing medical/scientific content.
  • Conduct in-depth analysis of data and monitor scientific literature for company products and analyze the information for accuracy/relevance.
  • Monitor and anticipate the changing therapeutic environment impacting opinion leaders and other interpretations of our programs’ data.
  • Participate in multidisciplinary therapeutic area teams; contribute to functional strategic plan supporting the therapeutic area.
  • Identify opportunities to address knowledge gaps and research opportunities
  • Support the preparation of, and participate in, internal and external scientific meetings and teleconferences.
  • Provide leadership, guidance and resources to maintain an organizational culture of innovation and advanced scientific and business acumen.
  • Assist with the strategic development and implementation of disease-related and asset strategies.

Job Requirements (Essential knowledge, skills and attributes):

  • Highly motivated, inquisitive and detail orientated
  • Exceptional organizational skills
  • A keen eye for detail encompassing scientific content
  • Ability to effectively communicate complex ideas, both orally and in writing with a strong command of the English language
  • Strong interpersonal skills, and an ability to interact confidently with colleagues, clients, and external experts
  • Vaccine and/or immunology experience is highly desirable
  • Exhibits strong ability to analyze, develop and execute on external-facing strategies.

Education/Training/Experience:

  • A minimum of a Master’s Degree is required, PharmD, or PhD highly preferred.
  • Minimum of 6-8 years of pharmaceutical industry clinical or research experience is required.
  • Experience developing responses to scientific inquiries and demonstrated ability to conduct literature analysis.
  • Demonstrated strength in Microsoft Office programs (Word, Excel, and PowerPoint) and Prism.