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Sr. Director / Director, Regulatory Affairs

Summary of Position:

The Director, Regulatory Affairs will lead development of regulatory strategy, build processes to ensure global regulatory compliance, and manage all regulatory submissions and interactions. The Director will prepare for meetings, teleconferences, and other communications with FDA and other regulatory agencies, educate teams regarding regulatory risks and implications for strategy and product development activities, and utilize technical knowledge and effectively apply regulations and guidelines to the product development process

Summary of Essential Duties to be Performed:

  1. Lead the development of global regulatory strategy, ensuring that programs meet quality and safety standards required by patients, health care providers, and regulatory agencies.
  2. Coordinate and balance priorities of various stakeholders (corporate, scientific, clinical) in the context of regulatory requirements, through active participation in Product Development Teams.
  3. Monitor product-related corporate activities for regulatory compliance, including CMC, nonclinical, and clinical plans and practices.
  4. Provide critical review of all documentation supporting regulatory applications, including organization of regulatory file rooms and document signatures.
  5. Lead the preparation and submission of regulatory submissions to FDA and other regulatory agencies.
  6. Plan, coordinate, and prepare for meetings and teleconferences with regulatory agencies.
  7. Monitor applicable current and new regulatory requirements.
  8. Review and update regulatory processes and documentation practices to ensure company is in compliance and audit ready
  9. Interact with company partners and consultants on regulatory matters.
  10. Contribute to the regulatory perspective on government proposals and external due diligence activities.

Summary of required/desired knowledge, skills, and other abilities or attributes:

For this role you will need

  • Advanced Degree (M.S. or Ph.D. preferred) in a Biological Science.
  • Minimum of 7 years of regulatory affairs biologics industry experience required, vaccine experience preferred.
  • Direct interaction experience with FDA required.
  • Thorough knowledge and practical application of domestic and international regulations including cGMPs, GLP, GCP and ICH.
  • Experience with submissions via eCTD (electronic gateway).
  • Excellent writing skills are required.
  • Excellent leadership, interpersonal, written and oral communication skills.

Associate Director / Director Clinical Development

Summary of Position:

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

Summary of Essential Duties:

  1. Assist in the development of Altimunne’s clinical research strategy for product candidates across preclinical development, clinical research, manufacturing and regulatory affairs.
  2. Manage internal and external resources to ensure clinical research plans are executed on time and within budget.
  3. Develop clinical trial protocols, investigator brochures, and other documents required to conduct clinical trials.
  4. Oversee management of clinical trials including investigator selection, analysis of patient recruitment strategies, milestones, coordination of lab samples, data collection and analysis.
  5. Identify suitable clinical trial sites and develop effective working relationships with clinical investigators and thought leaders.
  6. 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.
  7. 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.
  8. 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.
  9. Oversee development and maintenance of clinical SOPs related to GCP activities.
  10. Ensures that all Altimmune’s drug and vaccine clinical programs are conducted in accordance with Good Clinical Practice (GCP), ICH guidelines and all applicable regulatory requirements.
  11. Provide expert opinion and due diligence research on business development opportunities.
  12. Represent Altimmune’s clinical and medical strategy to internal and external stakeholders including the Board of Directors and investors

Summary of required/desired knowledge, skills, and other abilities or attributes:

For this role you will need

  • Medical degree/MD
  • Minimum five (5) years in either clinical practice or relevant setting, clinical research experience
  • Minimum one (3) year in pharmaceutical industry (clinical research, pharmacovigilance, or Medical Affairs) or equivalent
  • Knowledgeable in medicine and pharmaceutical product safety
  • Experience applying medical knowledge to the interpretation of individual case review

Clinical Trial Manager

Summary of Position:

Clinical Trial Manager plays an important part in the clinical trial process. The CTM position will perform a wide variety of activities to support the startup and completion of clinical research studies and may supervise other clinical operations personnel.

Essential Functions:

  • Assist in creating and managing the study project plan, including timeline, vendors, budget, and resources
  • Achieves study objectives 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
  • Assists 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.
  • Assists 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
  • Attends regularly scheduled cross-functional study team meetings with internal and external resources, CROs and site staff
  • Participates in CRO and other vendor selection and management
  • Co-monitors with CRAs as needed
  • 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):

  • 5+ years clinical research experience in an industry setting and a minimum of 2 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 MS Project for development and update of clinical study timelines
  • Track and manage contracts and budgets for assigned clinical trials