Job Opportunities at IAVI

Position Summary:

• Are you a Quality focused leader in clinical development, passionate about bringing forward public health solutions?
• IAVI is seeking an experienced and detail oriented Associate Director, Quality Assurance who will ensure compliance of clinical development operations to IAVI and industry standards. The Associate Director will facilitate the Clinical Development group’s participation in the IAVI quality management system where appropriate processes, procedures, and controls are established to ensure clinical research is conducted according to IAVI and industry standards.

Key Responsibilities:

• Support Project Teams with the development of quality management plans relevant to the specific project(s);
• Support and prepare Project Teams for regulatory inspections and external Sponsor audits;
• Serves as the GCP point person for the IAVI electronic QMS, and Clinical Trial Systems, development and implementation;
• Develop and implement QMS compliance assessments for the GCP component of the QMS;
• Develop and implement an eTMF inspection readiness assessment plan for all IND studies;
• Participate in executing the audit plan as delegated;
• Provide training to GCP Operations on best practices and trends as indicated;
• Oversees implementation of GCP CAPAs and conduct the required effectiveness checks;
• Perform other tasks as assigned by the manager.

Education and Work Experience:

• Masters Degree or equivalent in Clinical Research and/or Public Health or related field is required.
• Minimum 10 years of experience in clinical research is required of which at least 3 in Quality Assurance is required.
• Certification as GCP Auditor and/or Post Graduate Qualification in Quality Management is highly preferred.

Qualifications and Skills:

• Strong knowledge and understanding of industry standards and research operations as pertinent to vaccine development is required.
• Experience working with quality management systems is required.
• Experience working with electronic data and records in CFR21Part11 compliant environments is highly desirable.
• Experience as auditor of public health trials is highly desirable.
• Experience working in remote-, virtual-, global-, teams, is highly desirable.
• Ability to travel to research sites throughout the Africa region at up to 30%.

go to method of application »

Position Summary:

• IAVI is seeking a Director, Human Subject Research Quality, to lead HSR Quality Assurance, and oversee the development, implementation, and monitoring of global quality standards for HSR operations. This experienced Quality leader will lead HSR quality which includes Clinical studies (GCP & GCLP), epidemiological, as well as socio-behavioral research. The Director will be integral in driving quality oversight, implementing risk management strategies, and developing robust procedures for quality assurance in human subject research. If you're a seasoned professional with extensive experience in quality assurance and public health research, eager to make an impact in a mission-driven organization, apply now!

Key Responsibilities:

• Develop and maintain a database of quality standards for HSR operations.
• Develop and implement Quality Oversight Plans for HSR in line with QA objectives and industry standards.
• Track and monitor the progress of implementing Quality Oversight Plans.
• Report to the Senior Director on the execution of Quality Oversight Plans as per unit reporting requirements.
• Develop procedures to support quality oversight of HSR operations.
• Act as the point person for integration and alignment of HSR-related documents with IAVI’s guidance and procedures.
• Develop a training plan for HSR QA staff.
• Develop an annual internal audit plan.
• Review unit and project risk registers and develop/maintain an HSR Risk Register.
• Support the preparation of HSR sites for regulatory inspections and sponsor assessments.
• Oversee the work of Associate Directors for GCP and GCLP Quality Assurance and manage their teams.
• Facilitate the development of quality management systems and tools for HSR operations.
• Serve as the HSR QA representative on project teams.
• Perform other QA duties as assigned by the Senior Director of Human Subject Research Quality Assurance.

Education and Work Experience:

• Master's degree in Public Health or a related field is required.
• Minimum of 10 years of experience in managing public health Human Subject Research, with a minimum of 5 years in Quality Assurance is required.
• Extensive experience with global research operations and supporting global studies in an NGO environment is highly preferred.
• Strong background in risk management within a HSR environment.

Qualifications and Skills:

• Strong leadership skills with a cooperative approach.
• Expertise in process development and procedure platform creation.
• In-depth knowledge of quality management systems and their requirements.
• Proficient in risk management systems and problem-solving.
• Ability to work in a remote and virtual team environment.
• Outstanding communication skills with experience working in multicultural teams.
• Familiarity with therapeutic areas relevant to IAVI’s mission.
• Mobility to perform essential functions of the position.
• Ability to work in a virtual team.
• Ability to communicate clearly in person and via telephone.
• Regular travel (up to 40%) for audits, meetings, and inspections as needed, including travel to IAVI offices in New York and international sites.

go to method of application »

Position Summary

• The Product Development Team Leader (PDTL) provides overall leadership for the development strategy for IAVI’s Lassa Fever Vaccine Program. This PDTL leads a matrix and cross-functional team, working in close collaboration with the Project Management Lead (PML) to develop and execute an integrated Product Development Plan (iPDP).   The PDTL effectively integrates the development process through late-stage clinical trials, key milestones, and licensure related to product registration, global access, and vaccine introduction. This leader shepherds the program team through the iPDP within the parameters set by IAVI and its funders.

 Key Responsibilities:

• With members of PDT, set the overall Lassa Fever Vaccine Program cross-functional strategy with a goal to deliver an affordable Lassa Fever Vaccine solution to countries that need it.
• Oversee development of an integrated Product Development Plan (iPDP) to define the end-to-end product development strategy, and establish the Target Product Profile (TPP), key milestones, and deliverables for cross-functional execution through registration and global access.
• In alignment with the iPDP and the portfolio strategy, the PDTL will lead strategic decision making that enables milestone-driven execution and drives alignment across functional areas; ensure budget and timelines are met; and assess program risks, and adopts risk mitigation approaches.
• Resolve scientific, clinical, technical, and regulatory issues that emerge throughout development in collaboration with team members and functional area leaders, direct corrective actions when needed; and escalate significant or unresolved issues to IAVI internal governance committees.
• Guide the Product Development Team (PDT) through stage gate governance reviews and other internal decision-making processes to secure approval through each stage of development; partner with the PML on preparation of key materials using standardized tools, and templates for internal decision making.
• Maintain a deep understanding of the unmet public health needs, latest scientific data, and external landscape (including status of competitive products) for Lassa Fever and regional relevant diseases that may impact assessments of efficacy (e.g., malaria).
• Lead the internal cross-functional product team, in collaboration with the PML, with representatives from key areas (e.g., Pre-Clinical, Clinical, Quality, Manufacturing, Regulatory, Global Access, etc.) to work effectively and efficiently; inspire, coach and mentor team members; and resolve issues that emerge within the team in collaboration with relevant managers. Ensure that other support functions provide dedicated support and collaboration on overall program goals and deliverables (e.g., Legal, Finance, Human Resources, Business Development, etc.)
• Chair PDT meetings and work with the PML to establish agendas, scorecards, dashboards, and other Project Management tools and templates to monitor execution against goals and milestones.
• Drive achievement of milestones and key deliverables to progress program forward with urgency while maintaining the highest level of quality and compliance.
• Ensure effectiveness of funding, through external sources and/or internal investment, to sustain product development; identify funding gaps; review and approve development program budgets; build strong relationships with potential funders; and support funding proposal preparation and negotiations.
• With Impact Area Leader and Business Development, identify strategic needs and opportunities for partnership; explore potential partnership approaches, and forge partnerships and alliances to achieve product development objectives.
• Foster strong relationships with scientific leaders and organizations, donors, government agencies, academia, investigator networks, and other external stakeholders that align with the needs and objectives of the Lassa Fever Vaccine Program.
• Communicate and champion IAVI’s mission, network, and value as a partner internally and externally.

Education and Work Experience:

• MD or PhD in a science related field is required.
• Minimum of 10 years of experience including vaccine product development and program or team leadership experience is required.
• Experience with late-stage development of vaccines (pharmaceutical industry and/or biotech) with progression of programs through licensure is required.

Qualifications and Skills:

• Track record of success as someone who works with urgency and can quickly develop clear and concise decisions.
• High degree of leadership to build relationships, motivate teams, and influence at all levels of the organization.
• Strong organizational and communications skills with proven experience in fostering and establishing external partnerships and collaborations.
• Established track record of managing teams and projects, supervising staff, and ensuring that key activities are completed within deadlines and budgets.
• Strong interpersonal and intercultural skills and experience, and ability to work collaboratively with colleagues from a wide range of disciplines, countries, and cultures.
• Proven track record of delivering results and meeting targets is required.
• Ability to travel – up to 20% of time is required.
• In-depth knowledge/experience in the pharmaceutical or biotech industries with vaccine development required.
• Experience with clinical development and registration in LMICs is desirable.