Associate Director, Study Management

Precision for Medicine•Frederick, MD

About The Position

The Associate Director, Study Management directs the delivery of study milestones across multiple scientific teams, ensuring work meets cost, time, quality, and scope requirements. The role strategically leads direct and indirect reports, external partners, consultants, and financial budgets. It ensures assigned Project Directors lead scientific work supporting assay analysis for non-regulated, GLP-regulated, GCP-regulated, and commercial diagnostic (CLSI, CLIA) studies across Bioanalytical, Companion Diagnostic, Flow Cytometry, and Cell Biology teams. As a subject matter expert, the Associate Director applies knowledge of the industry, customer requirements, and business environment to implement strategic actions. The role collaborates with senior scientific and operational leaders to improve business processes, manages multiple projects and ongoing activities across PFM Specialty Lab teams, and serves as the authoritative source of study information. It leads study teams and deliverables, manages timelines, budgets, and quality targets, and ensures effective scheduling, records, and communications. The role defines operational strategies, timelines, resourcing, and budgets for study execution; establishes standards and best practices for the Project Director team; and partners with business unit leaders to assess development-program timelines, budgets, and opportunities. It also reviews objectives and development plans and conducts performance evaluations for direct reports. The Associate Director facilitates project hand-offs and kick-offs, identifies and escalates risks, serves as the initial escalation point for customer issues, and communicates regularly with customers about scope, direction, feedback, and performance. The role also identifies significant issues during clinical trials and proposes preventive or corrective strategies.

Requirements

Master’s degree in a life science or related field, such as engineering, or an accepted equivalent combination of education, training, and directly related experience.
At least 8 years of project management experience.
At least 3 years of management responsibility and strong leadership skills.
Outstanding leadership skills.
Excellent judgment and decision-making skills.
Direct experience overseeing ELISA, MSD, and Nab assays.
Experience working in a regulated environment, preferably GLP or GCP.
Superior knowledge of project management principles and their application.
Financial acumen and broad knowledge of budgeting, forecasting, and resource management.
Knowledge of regulatory guidelines and directives.
Superior process-improvement skills, especially as applied to project management.
Knowledge of laboratory operations and terminology.
Ability to read, write, speak, and comprehend English fluently.
A proven record of being a team player who interacts proactively and productively.
Must be legally authorized to work in the country of employment without employer sponsorship.

Nice To Haves

Master’s or PhD in Biology, Biochemistry, Immunology, Cell Biology, Molecular Biology, or a related field.
Experience in cellular, molecular, or biochemical science, such as hands-on research or laboratory experience in cellular biomarker analysis, protein-based assays, next-generation sequencing, IHC, or PK/PD assays.
Experience with project management software.

Responsibilities

Direct delivery of study milestones within cost, time, quality, and scope requirements.
Lead direct and indirect reports, external partners, consultants, and financial budgets.
Ensure Project Directors lead scientific work supporting assay analysis for non-regulated, GLP-regulated, GCP-regulated, and commercial diagnostic studies across relevant scientific teams.
Apply industry, customer, and business knowledge to adapt and implement strategic actions for the team.
Collaborate with senior scientific and operational leadership on continuous development and improvement of cross-functional business processes.
Set objectives for and manage multiple projects and ongoing activities across PFM Specialty Lab teams.
Act as the authoritative source of study information and lead study-level status reporting for each client.
Lead study teams and deliverables across functions; manage overall study timelines, budgets, and quality targets.
Ensure effective study-team scheduling, records, and communications.
Define operational strategy, timelines, resourcing, and budget needs for execution within the defined scope of work.
Establish operational standards and best practices across the Project Director team and ensure adherence.
Partner with business-unit leaders to assess development-program timelines and budgets and inform opportunity assessments.
Review annual individual objectives and development plans and conduct periodic performance evaluations for direct reports according to corporate policy.
Ensure timely project execution with a focus on quality deliverables.
Facilitate hand-off and kick-off meetings, identify risks, and develop and communicate contingency plans with project teams.
Ensure project risks and contingencies affecting time, quality, or cost are discussed with customers and senior leaders through appropriate escalation pathways.
Serve as the initial escalation point for customer issues.
Communicate regularly with customers to obtain direction and feedback on scope implementation and performance.
Identify unusual or significant problems during clinical trials and propose strategies to prevent or correct them.