JOB SUMMARY

We are seeking an experienced Clinical Development Executive to fill the role of Customer Relations Executive (CRE) to support our EU clients who are focused on infectious diseases including vaccines and COVID-19 related studies as part of the therapeutically focused Infectious Disease Therapeutic Area business unit. You will help develop the strategies for assets development and execution strategies for clinical trials related to infectious diseases and collaborate with business development and other stake holders to development of relationships and business for the infectious disease business unit. As a CRE you will oversee the operations and business aspects of a portfolio of multinational trials working with the Project Directors and Project Leads to achieve project milestone and deliverables as well as the target revenue and profitability metrics. You will also ensure the contracted services and expectations of all projects are carried out by the project teams in accordance with executed contracts and Customers' expectations. Your duties will include strategy development, budget planning, management of teams, the analysis of financial data, acting as the primary executive liaison with Customers, Vendors, Senior Management and Investigational sites including Key Opinion Leaders as needed. This role will also encompass assigned initiatives for organizational and process improvement and will require collaboration across the enterprise including commercial entities, early phase teams, various functional areas and specialty groups. You may have line management responsibilities for senior staff within the business unit.

Essential Functions:

You will provide oversight for all assigned Business Unit projects to ensure study launch, conduct and closeout occurs according to the Customer's and company's contractual agreement. You will ensure studies progress according to internal and Customer quality standards, SOPs, GCPs and ICH guidelines to fulfill all federal and local regulations.

You will forecast, prioritize and direct staff to achieve on-time quality sponsor deliverables, contractual project requirements, utilization goals and profitable results.

You will work with senior management and Business Development to set strategic direction for Business Unit to better target the types of projects across selected customer segments, you'll make recommendations, and drive the strategy execution for successful business growth.

You will evaluate the progress of your Business Unit projects and assigned staff to ensure the meeting of targets for utilization, realization, and timelines.

You will actively manage and mentor Project Management staff in leadership skills, customer management skills, project management skills, Trusted Process compliance, and for project specific tasks. You will ensure appropriate training and development is provided to all of your assigned staff.

As necessary, you will troubleshoot difficulties which may arise in project conduct between the company and Customer, and/or between Clinical Development. You will facilitate team building and communication. You will act as a liaison and facilitator between other functional areas for overall operational issues.

You will develop and maintains knowledge of current therapeutic/critical market environment and drug development trends as needed. You will facilitate team training in accordance with protocol and/or project requirements.

Other Responsibilities:

You will perform other work-related duties as assigned. Moderate travel may be required (up to 25%).

#LI-MS5QUALIFICATION REQUIREMENTS

You will have a Bachelor's degree in the life sciences, an advanced degree is preferred, plus extensive clinical research experience in a contract research organization, pharmaceutical, or biotechnology company. Your primary scientific focus should be in Infectious Diseases, and/or Vaccines. Experience in Pharma/Biotech and CRO, global clinical trials, product development, government and nonprofit organization relationships and an advance degree in an infectious disease related area or business is beneficial. You will have spent some time actively managing clinical research projects across functional areas. Previous supervisory experience and pharma/CRO experience is preferred. You will have a thorough knowledge of FDA regulations, drug development, and clinical monitoring procedures. You will have demonstrated proficiency with ICH/GCP guidelines, a proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail. Your flexibility and the ability to mentor and manage new staff and to handle multiple tasks to meet deadlines delivering high quality work in a dynamic environment will be essential. Requires strong presentation, documentation and interpersonal skills as well as a team-oriented approach.