This is an onsite role with hybrid flexibility based at our Frederick, MD facility; however, open to remote candidates who strongly align in areas of experience and background. Preference will be given to local candidates.

This role will lead new and existing CRO laboratory projects across a range of disciplines all with the focus on accelerating the development and adoption of novel therapeutics. This includes assay development and clinical testing, biorepository/sample management and logistics, and kitting for client studies spanning the globe. This is a key role which is client-facing, ensuring project plans are translated into action and results, requiring internal cross-functional leadership.

Provides focused project/program management services to projects/programs. Acts as a primary contact and lead for the client. Oversees the coordination and management of projects/programs by monitoring project status, timelines, and budgets. Serves as the cross-functional lead between the client, Business Development, and the project team facilitating the flow of information between all parties. Works closely with laboratory management to ensure that the project deliverables meet client expectations and financial commitments. Mentors Project Managers.

Essential Information:

• Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors
• A seasoned, experienced professional with an exceptional understanding of area of specialization; resolves a wide range of issues in creative ways
• Represents the department as a prime contact on projects/programs.
• Interacts with internal and external personnel on significant matters often requiring coordination between functional areas.
• Networks with senior internal and external personnel in own area of expertise. Excellent influencing skills
• Determines methods and procedures on new assignments and may coordinate activities of other personnel. Exercises judgment in selecting methods, techniques, and evaluation criteria for obtaining results.

Essential functions of the job include but are not limited to:

• Provides oversight and coordination of client portfolio for high value or pivotal client account studies. Provides oversight to internal departments and external clients to ensure the project requirements are understood, agreed to and followed at all times; this requires negotiating and real-time decision making with the clie
• Facilitates the flow of technical and clinical laboratory information to all stakeholders. Consults and utilizes, where appropriate, the scientific input of laboratory management and technical staff to assist the client with management of the projec
• Navigates ambiguity and has a system and process solution mindset to support growth and continuous improvement
• Directs and define project and study management activities for team members related to their project- oriented tasks to ensure that project/program milestones are m Assist clients and collaborators in the design and implementation of new studies, and in some cases may lead projects, in a Project Manager role, from start-up to closeout for top clients.
• Creates, tracks, and reports on project timelines
• Communicates with clients and collaborators with regard to data management, inventory control, shipping procedures, etc. for all assigned areas
• Produces and distributes status, tracking, and financial reports for internal and external stakeholders
• Prepares and presents project information at internal and external meetings; prepares reports and correspondences to clients, collaborators, and vendors
• Meets all revenue and gross margin objectives assigned to projects, project expenses, and client billi Ensures project/program budgets are reviewed on a monthly basis, and identifies an reports unexpected variances to the department director.
• Creates/tracks/reports relevant metrics for business and project measurement
• Assists senior staff, as required
• Identifies out of scope project work; escalate findings and action plans to appropriate parties
• Reviews, updates, and advances all documentation associated with project(s) to approvable status
• Leads the development of proactive contingency plans to mitigate risk across projects/programs
• Ensures that work product complies with design and performance standards, regulatory environment, and client expectations. Enforces standards applicable to each step in project execution; develop, lead and implement continuous improvement for assigned projects and programs
• Identifies, resolves, and assists in resolution of operational issues
• Influences and shapes the direction of project management, including recommendations regarding policies and practices
• Participates in functional and/or corporate initiatives, as well as special project assignments
• Monitors assignments and adjusts priorities and work schedules to meet deadlines and provide high quality deliverables. Completes additional tasks needed in support of project, client and departmental objectives
• Completes other responsibilities, as assigned

Qualifications:

Minimum Required:

Bachelor's degree in a life science or related field, plus a minimum of 8 years of project management experience in biotechnology, clinical trials, central lab, repository, or pharmaceutical industry; in some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Other Required:

• Excellent computer skills and experience with MS Office/MS 365 applications
• Proven track record of coordination and communication with team members across disparate technical and business backgrounds such as R&D, Operations, Finance, Business Development, Sales, Manufacturing, Executive Management, Quality Assurance, and Regulatory Affairs
• Exceptional communication, presentation, interpersonal, organizational, and multi-tasking skills
• Able to work in front of a computer for extended hours at a time
• Exceptional understanding of project management and data analysis
• Exceptional critical thinking, analytical, and problem-solving skills
• Exceptional research and reporting skills
• Exceptional use of judgment and discretion
• Able to read, write, and fluently speak and comprehend the English language
• Proven track record of being a team player, willing to interact proactively and productively
• Must possess a valid driver's license; must be able to travel both domestically and internationally, including overnight stays (~10-25%)
• Extended work hours may be necessary in order to meet business demands

Preferred:

• Master’s or PhD in Biology, Biochemistry, Immunology, Cell Biology, Molecular Biology or related field
• Experience with financial management, including building and managing budgets and financial reporting
• Experience in cellular, molecular or biochemical science such as hands-on research or lab experience in cellular biomarker analysis, protein-based assays, next-generation sequencing, IHC, or PK/PD assays
• Experience with project management software
• Familiarity with GCLP, GLP, GMP, CLIA, and ISO regulatory guidelines
• Familiarity with Smartsheet