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SalaryAs an organization whose mission is to translate science into global public health impact, working on vaccines and therapeutics, IAVI has a vaccine policy which states that subject to applicable law, we require all U.S. and Puerto Rico based employees to be vaccinated for COVID-19, unless they have an approved medical or religious exemption or accommodation. We are committed to supporting our employees during this process as we work to ensure a safe and healthy work environment.
Position Description
Job Title: Senior Director, Clinical Program Lead
Location: New York, NY Preferred; US-Remote will be considered; Nairobi Kenya, Cape Town South Africa, Remote-South Africa, Amsterdam Netherlands, United Kingdom
Reports to: Vice President, Clinical Development
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 and in meetings with donors and other external stakeholders
- Responsible for the development of the Clinical Development Plan, in collaboration with key internal functional leads (e.g., Clinical Operations, Biostatistics, Project Management, Regulatory, CMC), and if relevant, external stakeholders.
- 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 and medical 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.
- Mentors and trains Medical Monitors in building and implementing clinical development strategies.
- Sets strategy for Clinical 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 leading and writing the Clinical Development Plan is required.
- Experience with late-stage development and Biologics License Application (BLA) process is required.
- In depth knowledge and experience of drug development process, particularly vaccine 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 deal well with conflict and obstacles, and to work in a fast-paced environment.
- Willing to travel (up to 30%), as needed is required.
Organizational Overview:
IAVI is a nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges including HIV and tuberculosis. Our mission is to translate scientific discoveries into affordable, globally accessible public health solutions. Through scientific and clinical research in Africa, India, Europe, and the U.S., IAVI is pioneering the development of biomedical innovations designed for broad global access. We develop vaccines and antibodies in and for the developing world and seek to accelerate their introduction in low-income countries. IAVI programs and partnerships are grounded in the regions of the world where the disease burden is the greatest, and our approach emphasizes sustainability. Our network of clinical research center partners in Africa and India helps strengthen in-country research capacity and supports the training and education of the next generation of scientists. The global impact of our science includes fundamental contributions to understanding the biology of HIV infection, which IAVI and others are applying toward advancing vaccine science and immunology. IAVI accelerates scientific discovery and development by fostering unique collaborations among academia, industry, local communities, governments, and funders to explore new and better ways to address public health threats that disproportionately affect people living in poverty. Our global reach, including a clinical research network in five countries in sub-Saharan Africa and in India, has allowed us to make fundamental contributions to understanding the epidemiology, transmission, virology, and immunology of HIV. This work played a key role in facilitating the design of promising HIV vaccine candidates, as well as the discovery of broadly neutralizing antibodies that are now being advanced as promising approaches for HIV prevention. Our integrated capabilities in vaccine and antibody discovery, development, and clinical research take advantage of bio-pharmaceutical industry expertise to accelerate the development and testing of prevention methods for HIV and other diseases. Through the Product Development Center, we support external researchers with technical and scientific expertise to accelerate the development of their own products.
IAVI CORE VALUES:
- Dedication to the Mission: We are committed to the translation of scientific discoveries into affordable, globally accessible public health solutions.
- Innovative Evolution: We are committed to solving complex problems in creative and innovative ways, learning from our mistakes and successes and never giving up
- Integrity: We are committed to meeting the highest ethical and professional standards in everything we do and to taking responsibility for our actions to earn respect
- Collaboration: We are committed to embracing diversity, the power of global teamwork and the belief that by working as one we can make a difference
Disclaimer: Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities and skills required of personnel so classified. This document does not create an employment contract, implied or otherwise, other than an “at-will” relationship. IAVI is an equal opportunity employer and applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
IAVI IS AN EQUAL OPPORTUNITY EMPLOYER actively committed to fostering a diverse and inclusive global organization. IAVI believes that diversity and inclusion among our teammates is critical, and we seek to recruit, develop and retain the most talented people from a representative candidate pool. At IAVI, we celebrate the spectrum of colleagues’ experiences and believe that dedication to our mission above all is essential to our success as a scientific global non-profit. IAVI upholds these principles through IAVI’s Global Diversity and Inclusion Committee.
IAVI has zero tolerance for discrimination or harassment on the basis of race, color, ethnicity, caste, national origin, home language, ancestry, religion, marital or civil partnership status, age, physical or mental disability, HIV status and any other medical condition, genetic information, pregnancy, sexual orientation, gender identity or expression, and veteran status, in addition to any other status protected under the law in any of our locations worldwide.
Compensation and Benefits Information for US-Based Candidates:
Annual base salary for this position is: $180,000.00 - 220,000.00
Compensation And Benefits Information for NON-US Based Candidates:
Salary is paid in local currency, and is commensurate and competitive with the local labor market
Please note, there may be some variation based on experience level. In addition, this position offers competitive benefits such as annual bonus, generous retirement savings plan, competitive health insurance benefits, and other benefits.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
