Associate Director, Clinical Operations

Position Description

Job Title: Associate Director, Clinical Operations

Location: South Africa

Reports to:      Director, Clinical Operations

Position Summary:  

IAVI is seeking a highly qualified Associate Director, Clinical Operations who will supervise IAVI's South African Clinical Operations team, consisting of Clinical Trial Managers, Clinical Research Associates, Clinical Trials Associates, and consultants as needed. The successful candidate will oversee and will be responsible for all operational activities associated with the execution of assigned global clinical trials managed by the Clinical Development team based in Cape Town, South Africa, and other locations as needed. In addition, this position will ensure Clinical Operations resources, systems and processes are prepared to execute current and upcoming clinical research.  

Key Responsibilities:

Clinical Operations:

• Supervise staff to carry out global clinical operations as assigned, including regular check-in meetings, overseeing trainings and career development, and assessing performance of direct reports and addressing areas for development.
• Determine resource needs for current and future studies and hiring qualified staff, including:
  1. Work closely with Director, Clinical Operations to ensure staffing needs are identified, as well as FTEs and/or consultants are requested and approved as needed.
  2. Lead hiring process for clinical operations staff reporting into the position.
  3. Onboard/train new hires. 
• Ensure quality standards for all studies managed by assigned Clinical Operations team are met, including:
  1. Comply with ICH/GCP standards, National Regulatory Authority and Stringent Regulatory Authority (SRA) standards.
  2. Comply with responsibilities of a Sponsor conducting global clinical trials.
  3. Provide data that is auditable and able to support the application for approval of a clinical product by SRAs and National Regulatory Authorities, for example, in the US and Europe, as well as Africa or Asia.  
• Participate as member of the project teams.  
• Review reports from Clinical Operations personnel, sites, and/or CROs regarding study, including working with team members to identify risks and problems and propose resolutions.
• Support vendor selection, budgets, and contracts process.
• Perform other duties as assigned by the Manager.

Departmental and knowledge development activities:

• Provide support and back-up to senior departmental personnel, such as attending meetings, assuming lead in study team meetings or ad-hoc meetings, generating and/or reviewing minutes, and following up on action items.
• Act as back up when a Clinical Operations team member is temporarily unable to fulfill role (e.g. leave, illness, or pregnancy).
• Remain up to date on knowledge of clinical trial methodology, ICH GCP, FDA regulations, EMA Regulations, and other local/international regulatory and ethical guidelines and requirements., as well as arrange for trainings of staff as needed.
• Remain abreast of scientific knowledge of targeted disease, population, and investigational product(s).
• Participate in training activities for new staff.
• Identify and lead process improvement efforts, participating in SOP writing and revisions.
• Provide status reports on metrics associated with deliverables in terms of quality, productivity, budgets, and timelines and contribute to improving areas of cost- and time-effectiveness.
• Contribute to grant proposals and other fund-raising activities.

Education and Work Experience:

• Undergraduate degree required; Master's degree in relevant field is highly desirable.
• Minimum 8 years of clinical trial implementation experience is required; experience with direct line management with demonstrated success in mentoring and developing team members is highly desirable,

Qualifications and Skills: 

• Working knowledge of cross-functional areas associated with clinical development and operational execution of trials, including biostatistics, safety reporting, CRO/central laboratory/vendor management, budgeting of trials, responsibilities of Clinical Trial Managers, Clinical Research Associates, and Clinical Trials Associates is required.
• Expert knowledge of ICH/GCP guidelines, FDA CFR guidelines, Declaration of Helsinki, and relevant country specific regulations is required.
• Strong clinical project management skills are required.
• Experience with writing and negotiating Clinical Trial Agreements and other contracts is required.
• Proven track record of meeting organizational milestones, timelines, and working closely with teams to ensure clinical program objectives are met is required.
• Ability to work with complex governance structures and manage large numbers of stakeholders, as well as demonstrated experience in forming and managing effective collaborations, resolving conflicts as they arise is required.
• Ability to work well with all levels of staff both within an organization, across functions, and across cultures with demonstrated ability to work effectively in cultures and environments other than one's own is required.
• Self-motivation, detail-orientation, and ability to handle significant responsibility as well as shift priorities, exercising discretion and taking initiative to resolve problems is required.
• Strong written, verbal, and presentation skills are required.
• Strong computer literacy skills with software tools needed to fulfill the responsibilities of the position, including MS Outlook, Word, Excel, PowerPoint, Project, EDC, and eTMF platforms is required.
• Ability to travel up to 30% of the time is required.
• Experience in HIV, TB and other infectious diseases and vaccine clinical trials is highly desirable.

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.

 
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.