POSITION: PROJECT DIRECTOR-- PRODUCT DEVELOPMENT CENTER LOCATION: NEW YORK, NY POSITION SUMMARY: IAVI s Product Development Center (PDC) acts to assist both internal and external organizations and investigators to enable the progression of their projects through to clinical testing. The IAVI PDC operates as a virtual product development company, through the establishment of Product Development Partnerships with a range of CMOs and CROs and its in-house expertise in project management, pre-clinical, process development, regulatory affairs, quality assurance, clinical, and manufacturing to link the biological product designers with the appropriate expertise to facilitate accelerated development and testing of multiple candidate AIDS vaccines. IAVI is currently expanding its professional staff and is looking for individuals dedicated to excellence and motivated by our product development mission.
IAVI is seeking a Project Director with the principal responsibility of leading preclinical/Phase I program in association with a designated partner.
KEY RESPONSIBILITIES: Provide support in defining project strategy, risks and decision points. Support alignment amongst stakeholders on project strategy and goals, which include the conduct of a larger international efficacy study and manufacturing plans to support efficacy study and commercial preparedness. Lead an internal team (and collaborate with large group of external collaborators in a larger program team) to develop a project plan and deliverables which will achieve the project goals and align stakeholders on those plans Effectively communicate deadlines, constraints, risks and stakeholder expectations to project team members (and functional leaders.) Develop integrated and interdepartmental project plans, schedules/timelines and budgets for each areas of that project to ensure that goals are met. Ensure cross functional collaboration for plans that require cross functional participation, or which have cross functional deliverables. Provide adjusted plans for changing needs/requirements. Drive team to achieve project milestones as defined by the baseline plan. Provide project status reporting (progress, budget, issues) with internal and external stakeholders. Prepare status reports as required for each funder/stakeholder group (e.g., monthly, quarterly, annually). Communicate issues and risks to appropriate stakeholders. Manage day-to-day project operations including organizing internal and external project meetings ensuring effective communication and record-keeping. Work with team to proactively identify risks/issues and mitigation/solutions/contingency plans. Escalate issues first internally and then to stakeholders as appropriate. Support best project management practices in a fast project/product development environment including continuous improvement.
EDUCATION AND WORK EXPERIENCE: MS in life science or commensurate experience. At least 5 years of experience in project management in biopharmaceuticals; experience in government contracting is a plus Excellent organizational skills. Commitment to IAVI s mission. Experience with international projects is highly desirable. Knowledge of GXPs and /or quality assurance and regulatory affairs associated with biopharmaceutical development is highly desirable. Ability to be successful in a home-office environment Excellent verbal and written communication skills, including good negotiation skills Experience working with senior leadership PMP certification is a plus.
OTHER KNOWLEDGE, SKILLS, AND ABILITIES: Proficient in MS Office (Outlook, Word, PowerPoint, Excel) and MS Project
Work Environment and Physical Demands: 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 (potential for home office-based work) Occasional travel off-site for team meetings with collaborators, as needed (up to 20%) Ability to travel to IAVI offices in New York (up to 10 times per year) Other Duties: Perform other duties as assigned
ORGANIZATIONAL OVERVIEW: The International AIDS Vaccine Initiative (IAVI) is a nonprofit scientific organization whose mission is to develop vaccines and other biomedical innovations that prevent HIV infection. 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 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 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
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.
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.