Project Leader – Vaccine, Infectious Diseases at Emmes Company
Project Leader– Vaccine/Infectious Diseases
- Position Location United States – Remote
- Job Code 2779
- # of openings 1
The Emmes Company, LLC (“Emmes”) is searching for a Project Leader for our Vaccine/Infectious Diseases Research Unit. Emmes provides flexibility for the office location or work remote preference dependent upon position.
Emmes is a Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over nine hundred staff worldwide with offices located in Frederick, Maryland, Vancouver, Canada and Bangalore, India. Ranked as a top area workplace of choice by the Washington Post, Emmes fosters an environment of collaboration, professional growth, and exceptional work life balance.
Our studies impact public health initiatives on a global scale occurring in more than sixty countries spanning across six continents. We are dedicated to providing statistical and epidemiological expertise, computer systems deployment, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in biomedical research. Emmes offers support for the entire process of clinical trials from study design and protocol development through data analysis and manuscript generation.
The Project Leader successfully execute clinical research projects while maintaining a positive, effective, and responsive relationship with clients. As an expert in clinical research, the Project Leader uses professional concepts in developing resolution to critical issues. Holding primary accountability for technical, scientific, fiscal and management oversight for one or more projects within the Vaccine and Infectious Disease (VID) research unit, the Project Leader proactively communicates with internal and external stakeholders to provide timely resolution for strategic issues that impact upon project outcomes. As a leader in the organization, this position may partner with the business development team to generate and grow new business.
The VID Therapeutic Research Unit (TRU) supports vaccine and infectious disease research across a wide range of disease areas, including: Malaria, Tuberculosis, Influenza, Ebola, MRSA, STI and Enteric pathogens, and emerging infectious diseases. VID supports Phase 1-4 clinical trials investigating vaccines and treatments for bacterial, viral, and parasitic agents, as well as epidemiological studies. Primary services include statistical design and analysis; bioinformatics support; implementation of Emmes’ proprietary software for electronic data collection, data management, and electronic specimen tracking; preparation of study-related materials and web site development; generation of safety, regulatory, and final reports and manuscripts; clinical site training, assessment, and technical assistance; and study communication and collaboration.
- Accountable for technical, scientific, fiscal, and overseeing of clinical research projects working with staff at Emmes responsible for research support activities, including but not limited to Clinical Operations, Statistical and Scientific Innovation, Regulatory Affairs, and Pharmacovigilance.
- Proactively assesses client expectations and addresses client’s needs for ongoing studies/support and engages with clients for new opportunities in support of future studies.
- Reviews, provides input on, and approves project and study documents and processes, as needed.
- Represents the project or company at client meetings and scientific conferences.
- Utilizes broad understanding of therapeutic, clinical trial design, and/or process expertise to influence and executes project decisions considering client needs, budget considerations and the current state of the research field.
- Defines solutions with input from team members that will be implemented to meet client’s needs that address contractual aspects of projects (e.g., project contracts, scope of work, budgets, subcontracts, vendor agreements) to ensure delivery of high-quality contract deliverables.
- Defines solutions with input from team members that will be implemented to mitigate risk and communicate risks and contingencies with clients.
- Approves initial budgets and statement of work documents and subsequent modifications before distribution to clients.
- Liaises with corporate services and leaders from other Emmes verticals and departments to ensure staff resources are adequate within the project team to successfully meet the client’s requirements.
- Participates in project review meetings with TRU Directors and/or TRU Oversight, and Commercial and Service Project Oversight, if applicable.
- Uses established key performance metrics to assure successful delivery of the project that meet client requirements
- Supervises, mentors, and supports lower level project leaders (if applicable) to ensure they are properly trained for their current positions and have growth and development opportunities.
- Mentors project staff from other verticals pursuing a Project Leader role within the Therapeutic and Research Units.
- Participates in relevant corporate meetings and provides information learned and best practices to project team as applicable.
- Implements relevant corporate initiatives directed towards Project Leaders and therapeutic research areas, taking into account project budget considerations.
- Provides support to the Chief Business Officer as a subject matter expert in a therapeutic or research area and discusses business opportunities with clients and study collaborators, as appropriate.
- Contributes to the development of operational strategy, budget, and proposal content for new business opportunities.
- Demonstrated working knowledge of the principles of clinical trial management and operations with at least 3 years of management experience in a research environment
- Prior CRO/pharmaceutical management of late-stage clinical trials
- Demonstrable track record of success delivering complex/high-priority clinical trials within the agreed time, quality, and cost
- Demonstrated strong problem solving and analytical skills, combined with sound business judgment
- Ability to work proactively and effectively, with creative problem-solving and collaboration skills
- Highly motivated with ability to work independently and as part of a multi-disciplinary team
- Strong cross-functional project management and time management skills
- Excellent verbal and written communication skills
- Experience with vaccine and infectious disease clinical trials is preferred
- Associate Project Leader: Bachelor’s degree, preferably in a scientific discipline, with at least 6 years of experience within pharma and/or CRO; Master’s degree with at least 4 years of experience within pharma and/or CRO; PhD with at least 1 year of experience within pharma and/or CRO
- Project Leader: Bachelor’s degree, preferably in a scientific discipline, with at least 8 years of experience within pharma and/or CRO; Master’s degree with at least 6 years of experience within pharma and/or CRO; PhD with at least 3 year of experience within pharma and/or CRO
- Senior Project Leader: Bachelor’s degree, preferably in a scientific discipline, with at least 11 years of experience within pharma and/or CRO; Master’s degree with at least 9 years of experience within pharma and/or CRO; PhD with at least 6 year of experience within pharma and/or CRO
Three Project Leader levels are available. The selected candidate will be hired for the highest level matching his/her qualifications.
The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.
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