Associate Project Director, Translational Lab Services

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 cli
• eFacilitates 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 proje
• cNavigates ambiguity and has a system and process solution mindset to support growth and continuous improvemen
• tDirects 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 timeline
• sCommunicates with clients and collaborators with regard to data management, inventory control, shipping procedures, etc. for all assigned area
• sProduces and distributes status, tracking, and financial reports for internal and external stakeholder
• sPrepares and presents project information at internal and external meetings; prepares reports and correspondences to clients, collaborators, and vendor
• sMeets 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 measuremen
• tAssists senior staff, as require
• dIdentifies out of scope project work; escalate findings and action plans to appropriate partie
• sReviews, updates, and advances all documentation associated with project(s) to approvable statu
• sLeads the development of proactive contingency plans to mitigate risk across projects/program
• sEnsures 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 program
• sIdentifies, resolves, and assists in resolution of operational issue
• sInfluences and shapes the direction of project management, including recommendations regarding policies and practice
• sParticipates in functional and/or corporate initiatives, as well as special project assignment
• sMonitors 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 objective
• sCompletes other responsibilities, as assigne

dQualifications

:
Minimum Require

d: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 rol

e.
Other Requir

• ed:Excellent computer skills and experience with MS Office/MS 365 applicati
• onsProven 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 Affa
• irsExceptional communication, presentation, interpersonal, organizational, and multi-tasking ski
• llsAble to work in front of a computer for extended hours at a t
• imeExceptional understanding of project management and data analy
• sisExceptional critical thinking, analytical, and problem-solving ski
• llsExceptional research and reporting ski
• llsExceptional use of judgment and discret
• ionAble to read, write, and fluently speak and comprehend the English langu
• ageProven track record of being a team player, willing to interact proactively and productiv
• elyMust possess a valid driver's license; must be able to travel both domestically and internationally, including overnight stays (~10-2
• 5%)Extended work hours may be necessary in order to meet business dema

nds
Prefer

• red:Master’s or PhD in Biology, Biochemistry, Immunology, Cell Biology, Molecular Biology or related f
• ieldExperience with financial management, including building and managing budgets and financial repor
• tingExperience 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 as
• saysExperience with project management soft
• wareFamiliarity with GCLP, GLP, GMP, CLIA, and ISO regulatory guidel
• inesFamiliarity with Smarts