Product Development Team Leader—Lassa Fever Vaccine Program at IAVI

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.