Associate Director, Study Management

Position Summary:

The Associate Director, Study Management will work effectively across multiple scientific teams to direct the delivery of study milestones within cost, time, and quality requirements. Strategically leads both indirect and direct reports, as well as external partners, consultants, and financial budgets to ensure we delivery study milestones on time and within the defined scope of work. Ensure that the assigned Project Directors act as the responsible scientist to lead and direct scientific work to support analysis of assays for non-regulated, GLP-regulated, GCP-regulated and commercial diagnostic (CLSI, CLIA) regulated studies across all scientific teams; Bioanalytical, Companion Diagnostic, Flow Cytometry and Cell Biology.

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

• As Associate Director, Study Management you are a subject matter expert and leverage your knowledge of industry, customer requirements and general business environment to adapt and implement strategic actions for the team.
• Collaborate with senior scientific and operational leadership to provide continuous development/improvement of business processes to support cross-functional teams and to ensure that work is uniform, complete, and managed appropriately.
• Set objectives for and manage multiple projects and the ongoing work activities across PFM Specialty Lab teams.
• Act as a single, authoritative source of study information and leads study level status reporting per client; lead the study team and associated deliverables across all functions; accountable for managing and driving overall study timelines, budgets, and quality targets to meet or exceed business needs.
• Accountable to ensure effective study team scheduling, records, and communications.
• Define optimal operational strategy and define timeline, resourcing, and budget needs for execution of the study plans to the defines scope of work.
• Establish and ensure adherence to operational standards and best practices across the Project Director team.
• Partner with business unit leaders to assess development program timelines and budgets to inform the assessment of opportunities for the category.
• Review annual individual objectives and development plans and perform periodic performance evaluation of direct reports following global or local corporate policy.
• Ensures the timely execution of projects with a focus on quality deliverables. Facilitates hand-off meetings and kick-off meetings to identify potential risks and work with the project team to develop and communicate contingency plans.
• Ensures project risks and potential contingencies impacting time/quality/cost of deliverables are discussed with customers and senior leaders through appropriate escalation pathways.
• Serves as the initial point of escalation for customer issues. Communicates with customer(s) regularly to obtain direction and feedback on implementing scope of work as well as performance to date. Identifies unusual or significant problems encountered during the course of a clinical trial and proposes strategies for preventing or correcting significant problems.

Qualifications:

Minimum Required:

Master’s degree in a life science or related field (e.g., engineering), plus a minimum of 8 years of project

management experience and a minimum of 3 years of management responsibility and strong leadership skills; 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:

• Outstanding leadership skills
• Excellent judgment and decision-making skills
• Direct experience in oversight of ELISA, MSD and Nab assays
• Experience working in a regulated environment, preferably GLP or GCP
• Superior knowledge of project management principles and application
• Extensive financial acumen with broad knowledge of budgeting, forecasting, and resource management
• Knowledge of regulatory guidelines and directives
• Superior skills in process improvement, especially as it applies project management
• Knowledge of laboratory and laboratory terminology
• 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

Preferred:

• Master’s or PhD in Biology, Biochemistry, Immunology, Cell Biology, Molecular Biology or related field
• 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