Medical Director, Early-Stage Clinical Development - International AIDS Vaccine Initiative : Job Details

As 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 DescriptionJob Title: Medical Director, Early-Stage Clinical Development Location: New York, NY Preferred, US-remote considered Reports to: Vice President and Head of Clinical Development Position Summary: Are you an experienced early development clinical Leader, who is eager to help translate science into global health solutions? IAVI is seeking a Medical Director to lead a Clinical Development Matrix Team working on IAVI's early-stage product development programs, which include vaccines and biologics (e.g., monoclonal antibodies) developed by IAVI or insourced from co-development partners. The Medical Director will design and strategize Phase 1 and 2 clinical protocols and ensure clinical trial sites are executing studies with the highest standards of scientific integrity, safety, and ethics. The Medical Director, who will have substantial early-stage product development experience will serve as a scientific liaison with pre-clinical development teams, ultimately helping to advance candidates into the clinic. Key Responsibilities:

• Serves as Clinical Development Lead for IAVI's early-stage vaccine or biologics development programs.
• Develops the integrated Clinical Development Plan ensuring all activities required for the preparation and execution of early-stage clinical trials are included to support eventual product access and delivery.
• Develops clinical trial strategies and collaborates with Regulatory Affairs and Clinical Operations for implementation of plans and procedures for clinical trial activities.
• Provides medical oversight of clinical protocols, consent forms, data collection instruments, and preparation of suitable educational materials and regulatory documents.
• Ensures that the Investigator Brochure/Investigational Medical Product Dossier (or equivalent) is complete and updated on an annual basis.
• Provides advice to preclinical groups on the design of studies and their relationship to the overall clinical development plan, as appropriate.
• Responsible for designing the clinical strategy that will generate data required for design of POC and Phase 3 efficacy trials that are appropriate to the target populations.
• Responsible for designing clinical research studies that generate data and clinical specimens that may elucidate the natural history, pathogenesis, and immune control of infection relevant for vaccine design and efficacy endpoints.
• Contributes to scientific assessments of internal and external candidate vaccines or biologics that IAVI might wish to consider and provides expert medical opinion and risk assessments required for prioritization and selection for further development.
• Leads communication with Principal Investigators responsible for conduct of early-stage trials and with the medical representatives of external product developers as required.
• Collaborates with Biostatistics, Safety, and Regulatory Affairs to ensure timely development of statistical analysis plans occurs and leads conduct of the interim and final analysis meetings.
• When required, serves blinded Medical Monitor for selected clinical trials, including working with site investigators to collect and interpret data required by the Safety/PV team for assessment of product safety.
• Prepare interim and final Clinical Study Reports in collaboration with site investigators and other members of IAVI Departments, collaborating with site investigators to collect, analyze and report the data from studies at scientific meetings and through publications.
• Supports the Impact Area Lead responsible for strategic planning for portfolio expansion and clinical trials to evaluate novel products.

Other duties

• Contribute to development of grant applications and reports for donors and granting agencies, in collaboration with the IAVI Development group.
• Contribute to development and reviewing of scientific and medical content of IAVI documents such as the IAVI Report and other IAVI educational materials.
• Represent IAVI at scientific meetings, including delivering oral presentations and posters.
• Maintain in-depth medical/scientific knowledge about the assigned therapeutic area or product, including any unique properties involving both disease and products for which the incumbent is responsible.
• Attend appropriate outside meetings and courses to maintain competency and awareness in assigned area, worldwide activities, and the vaccine community at large.
• Willingness to travel at least 20% of the time.

Education and Work Experience:

• MD or equivalent degree is required.
• Minimum 6 years of experience in clinical research is required.
• Board certification or equivalent in Medicine, Pediatrics, Infectious Diseases, or pharmaceutical medicine is highly desired.

Qualifications and Skills:

• Experience in preparing for and executing clinical trials or studies in international resource constrained settings is required.
• Knowledge and experience with implementation of Good Clinical Practices (GCP) in clinical trials conduct is required.
• Experience leading and managing teams involved in clinical research is required.
• Experience operating within a scientific, social, medical, or clinical research program is required.
• Understanding of ethics and regulatory landscape in LMICs is required.
• Experience working in developing countries, especially Africa region, is required.
• Experience in the development and implementation of site preparation activities for clinical trials, particularly in developing countries is required.
• Diplomatic skills, excellent judgment, proven ability to present programs to all audiences ranging from high level political to lay community groups.
• Strong organizational skills, resourceful, and mature self-starter, with proven experience in building a strong, coherent program and operations in resource poor settings with limited infrastructure.
• Ability to work in a decentralized system and maintain close working relationships with various departments throughout IAVI's global locations.

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: The annual base salary for this position is targeted at$215,000.00 - 250,000.00 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, three health insurance plans to choose from, 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)