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.

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.