Vacancies at International AIDS Vaccine Initiative (IAVI)

Position Summary:

Are you a passionate Life sciences manufacturing leader in who’s eager to translate science into global health solutions? If you are a GMP manufacturing expert with extensive leadership experience as well as vaccine experience, learn more and apply below!

IAVI is seeking an Experienced Leader who has depth of expertise in all phases of manufacturing processes, including drug substance, drug product, and development of analytical control strategies.  The Head of Manufacturing is accountable for process design, leading internal and external partners to establish critical quality attributes of drug substance, drug product, qualifying raw materials throughout the R&D life-cycle. The Head of Manufacturing is a GMP expert, as well as a seasoned leader who drives strategic decisions impacting the scale-up and development of best-in-class vaccines and treatments.

Key Responsibilities:

• Accountable for product and process development, scientific and engineering quality, and ensures all product quality attributes are understood and controlled through manufacturing and analytical controls. 
• Partners with leadership on cross-functional teams to deliver and maintain processes and controls that are timely, phase-appropriate, and compliant, to meet clinical and commercial supply needs.
• Understands and responds to business priorities and translates these into tactical objectives and work direction.
• Mitigates risks to production schedules and program deliverables when necessary and ensures an effective tech transfer/process.
• Develops and executes a plan for validating the manufacturing process for IAVI’s portfolio of programs, each at various stages of development.
• Work with functional expertise throughout IAVI to conduct risk assessments for critical processes and develop mitigations plans.
• Collaborate with internal and external partners to develop and validate plans for at-scale production and drive the execution of these plans.
• When required, define protocols for tech transfers and facilitate evaluation and processes to ensure successful design of production, ensuring GMPs are fully integrated.
• Work with internal stakeholders (e.g., Regulatory) to ensure validation strategies fit within IAVI and our funders strategy.
• Collaborate with project management to maintain a detailed timeline for the activities that must be completed – communicate to team when activities are at risk of causing delays to timeline.
• Manage manufacturing to support commercial production.
• Understand process and analytical requirements for the entire process.
• Communicate process requirements to facilities engineers fit for purpose design.
• Creatively apply experience to ensure process design specifications are met on time and with high quality standards.
• Manage contract manufacturing oversight activities, such as reviewing of pre-campaign documentation, batch records, deviations, and approving batch release documentation.

Education and Work Experience:

• Advanced degree or PhD in Biochemistry, Chemistry, Chemical or Bioprocess Engineering, Biology, or related field is required.
• Minimum of 15 years’ experience in biopharmaceutical/pharmaceutical manufacturing environment, with a minimum of 5 years’ senior management experience.
• Experience in early and late-stage product development, ideally having successfully been involved with bringing a product(s) to licensure.

Qualifications and Skills:

• Prior vaccines manufacturing experience is required.
• In depth experience with technology transfer and process validation is required.
• Experience overseeing CMOs and partnering with these organizations to drive results is required.
• Ability to dissect a manufacturing issue, conduct root cause assessments, and design experiments to test hypotheses stemming from manufacturing observations.
• Strong ability to motivate, mentor, and connect with peers and team members.
• Experience with CRO oversight, ensuring compliance with relevant regulatory standards required.
• Experience successfully managing and utilizing project management tools
• Ability to work across teams and SMEs to integrate information into centralized plans.
• Curiosity and drive to quickly come up to speed; creativity to solve challenging problems.
• Strong interpersonal skills, with excellent written and verbal communication skills.
• Ability to travel domestically and internationally as needed.
• A mission-driven individual with high energy and high levels of perseverance; works towards both individual and team goals.

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Position Summary:

Are you a Clinical Development Leader who is eager to make in impact in a mission-driven organization? IAVI is seeking a Senior Director, Clinical Program Lead to lead IAVI’s Lassa vaccine late-stage development program – Learn more and apply below!

This Senior Director, Clinical Program Lead will serve as the Clinical Lead for IAVI’s Lassa vaccine late-stage development program. The Clinical Program Lead leads the design and successful implementation of the Clinical Development Plan (CDP). The Clinical Program Lead leads a matrix team of members of the clinical development sub-functions to facilitate the development of the CDP and its implementation.  The Clinical Program Lead represents the clinical development functions on the Program matrix teams and collaborates actively to facilitate the integrated vaccine development program. The Clinical Program Lead drives development of strategies to identify, monitor and mitigate program level issues and risks that effect execution of the CDP and ensures for timely communication to the program team and management. The Clinical Program Lead leads the design of clinical trials and development of protocols to meet the CDP objectives and contributes to key regulatory and study level documents, including the review and dissemination of study results and related publications.

Key Responsibilities:

• Represents the clinical development functions (for the Program) at the Program matrix team.
• Collaborate with key internal function leads (e.g., Project Management, Regulatory, CMC, Quality), the broader CD team, CROs, and external stakeholders to support the development, design, and implementation of the CDP.
• Lead the cross-functional team implementing the CDP and develops strategies to identify, monitor and resolve program issues and risks.
• Play a key role in communicating across lines and functions to facilitate timely and effective decision-making and to identify key questions to ensure robust assessments.
• Communicate to management and relevant functions any potential issues or risks (e.g., changes or significant risks to the Clinical Development Plan, new safety concerns) in a timely manner.
• Provide scientific input and strategy for regulatory document creation (e.g., briefing documents, IND, NDAs) and participate in regulatory interactions.
• Review study documents including, but not limited to Investigator Brochure, Safety Monitoring Committee charters, clinical study reports, informed consent forms, statistical analysis plans, study manuals and publications associated with the clinical trials.
• Reviews, monitors, and interprets safety and efficacy data within clinical program.
• Sets strategy for Advisory Boards and builds strong relationships with KOLs and patient advocacy groups; make scientific presentations at advisory boards, key scientific meetings, and external committee meetings.
• Maintain scientific knowledge in relevant therapeutic disease areas and stay current with relevant information, studies, while maintaining a strong network of KOLs.
• Ensure compliance with SOPs, ICH, GCP, GPP, and other national and international regulatory requirements.

Education and Work Experience:

• Medical Doctor (M.D.) or PhD preferred; Advanced degree in scientific or related field is required.
• Minimum of 12+ years’ experience in relevant pharmaceutical/biotechnology industry with 5+ years of direct experience leading global clinical development programs from Phase 1-3 required.
• Experience in infectious diseases and or vaccine development highly preferred.
• Experience with clinical trials in Africa region is highly preferred.

Qualifications and Skills:

• Strong leadership skills and experience with proven ability to influence and collaborate with peers and team members.
• Experience with late-stage development and NDA is required.
• In depth knowledge and experience of drug development process, particularly vaccine or monoclonal antibody development and oversight of clinical trials is required.
• Experience leading clinical sections of regulatory documents is required.
• Demonstrated ability to make significant decisions and recommendations and persuasively present data and support materials to gain approval and sponsorship for projects from senior management.
• Experience optimizing extensive knowledge of the clinical development process and strong relationships with team members, colleagues, and internal and external stakeholders to achieve results.
• Excellent communication (oral and written), analytical, organizational, and project management skills.
• Ability to develop and maintain strong, collaborative relationships with key internal and external stakeholders.
• Ability to multi-task well, to deal well with conflict and obstacles, and to work in a fast-paced environment.
• Willingness to travel (up to 30%), as needed is required.