Associate Director, Clinical Operations (HQ)
United States, New York
Senior Director, Global Clinical Operations
The Associate Director, Clinical Operations supervises IAVI’s US Clinical Operations team, consisting of Clinical Trial Managers, Clinical Research Associates, Clinical Trials Associates, and consultants as needed. This position oversees and is responsible for all operational activities associated with the execution of US and global clinical trials managed by the HQ Clinical Development team. This position works closely with the Senior Director, Global Clinical Operations to ensure Clinical Operations resources, systems and processes are prepared to execute current and upcoming clinical research.
This is an office-based position requiring a minimum of 3 days per week in office. Other arrangements (e.g., flexible work hours, additional work from home days) may be negotiated at the discretion of the Senior Director, Global Clinical Operations.
Supervise HQ-based staff to carry out global clinical operations. Includes regular check-in meetings, overseeing training and career development, and assessing performance of direct reports and addressing areas for development.
Accountable for determining resource needs for current and projected studies and hiring qualified HQ-based staff. Includes:
Work closely with Senior Director, Global Clinical Operations and Chief Medical Officer to ensure staffing needs are identified, FTEs and/or consultants are requested and approved as needed
Lead hiring process for HQ clinical operations staff.
On-board/train new hires
Ensure quality standards for all studies managed by HQ Clinical Operations team are met and:
o Comply with ICH/GCP standards, National Regulatory Authority and Stringent Regulatory Authority (SRA) standards,
o Comply with responsibilities of a Sponsor conducting global clinical trials, and
o 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.
Provide status reports on metrics associated with deliverables in terms of quality, productivity, budgets, and timelines. Make suggestions and demonstrate best efforts in areas of cost- and time-effectiveness in all departmental activities, as well as others in which IAVI is engaged.
Participate as member of project teams. Ensure effective collaboration of cross-functional activities and clinical study teams with other functional groups.
Review regularly updated reports from Clinical Operations personnel, sites, and/or CROs regarding study progress including recruitment and trial conduct. Work with team members to identify site-related problems and propose resolutions as needed.
Work on vendor selection, budgets and contracts as requested by the Senior Director, Global Clinical Operations.
Identify and lead process improvement efforts. Participate in SOP writing and revisions as requested.
Stay up to date on required training's, including identification of changes in US, EU and other applicable regulations and best practices. Arrange for training's of ops staff as needed.
Contribute to grant proposals and other fund-raising activities as requested.
Act as back up when a Clinical Operations team member is temporarily unable to fulfill role (e.g. leave, illness, or pregnancy).
Other duties as assigned.
Education and Work Experience:
Other Knowledge, Skills, and Abilities:
- Undergraduate degree required; Master’s degree in relevant field preferred
- Minimum 10 years of clinical trial implementation experience
- Experience with direct line management strongly preferred, with demonstrated success in mentoring and developing team members
Work Environment and Physical Demands:
- 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
- Expert knowledge of ICH/GCP guidelines, including risk-based approaches
- Strong clinical project management skills
- Experience with writing and negotiating Clinical Trial Agreements and other contracts
- Proven track record of meeting organizational milestones, timelines, and working closely with teams to ensure clinical program objectives are met
- Ability to work with complex governance structures and manage large numbers of stakeholders; demonstrated experience in forming and managing effective collaborations, resolving conflicts as they arise
- Ability to work well with all levels of staff both within an organization, across functions, and across cultures; demonstrated ability to work effectively in cultures and environments other than one’s own.
- Self-motivated, detail-oriented and capable of handling significant responsibility as well as shifting priorities; exercises discretion; takes initiative to resolve problems
- Strong written, oral communication, and presentation skills essential
- 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
- Experience in HIV, other infectious diseases or vaccine clinical trials preferred
The work environment and physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Mobility to perform the essential functions of the position
Hearing and speech sufficient to verbally communicate in person and on the telephone constantly (66-100%)
Typical office environment
Occasional domestic and international travel, as needed (up to 20%, typically 10-15%)
Ability to travel to New York City IAVI offices
- Perform other duties as assigned
The International AIDS Vaccine Initiative (IAVI) is a nonprofit scientific organization whose mission is to translate scientific discoveries into affordable, accessible public health solutions to help the people who need them the most. Since its founding in 1996, IAVI has provided scientific, research and development, and policy leadership to address the needs of communities and key populations at risk for HIV infection around the world. IAVI works with more than 100 academic, industry, government, civil society, clinical, and community partners in more than 25 countries. IAVI is committed to supporting the broad field of HIV vaccine research and to fostering collaborations that accelerate the development and availability of new prevention tools. In pursuit of our goals, we work to catalyze and support novel partnership models that engage partners from both the public and private sectors across the product development continuum.
IAVI’s global reach, including its clinical research network in five countries in sub-Saharan Africa and in India, has allowed IAVI to make fundamental contributions to understanding of the epidemiology, transmission, natural history, virology, and immunology of HIV infection. This work played a key role in facilitating the structure-based 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. IAVI’s integrated capabilities in vaccine discovery, development, and clinical research take advantage of biopharmaceutical industry expertise to accelerate the development and testing of novel HIV vaccine candidates.
In addition to its core HIV vaccine effort, IAVI is working to amplify its global health impact by working with partners to address other urgent unmet public health needs – such as vaccines for other infectious diseases – where our existing technologies, assets, and experience can add unique value.
IAVI Core Values
Dedication to the Mission:
We are committed to the development of safe, effective, accessible, preventive HIV vaccines for use throughout the world to achieve a world without AIDS
We are committed to solving complex problems in creative and innovative ways, learning from our mistakes and successes and never giving up
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
We are committed to embracing diversity, the power of glocal teamwork and the belief that by working as one we can make a difference
Leadership and Communication
- Proactively ask questions to understand organizational strategy and performance objectives
- Come up with new and unique ideas to achieve objectives
- Take proactive steps to collaborate with members from other teams/departments
- Seek solutions to a system/process failure
- Positively handle criticisms, complaints, and special requests
- Directly communicate with manager, peers and team members
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.
All IAVI employees are expected to follow and abide by the legal, financial, regulatory, safety, and other general guidelines of IAVI, and to conduct their activities in a manner consistent with the highest personal and professional standards.
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.