Precision for Medicine

Global CRO for precision medicine trials

Associate Director - Study Management

Clinical Research OperationsConfirmed live in the last 24 hours

Full-timeFrederick, MD, USAIn-person

About the Job

Requirements

A Master's degree in a life science or related field, such as engineering, or an accepted combination of appropriate education, training, and directly related experience.
At least 8 years of project management experience and at least 3 years of management responsibility.
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.
Extensive financial acumen and broad knowledge of budgeting, forecasting, and resource management.
Knowledge of regulatory guidelines and directives.
Superior skills in process improvement, especially as applied to project management.
Knowledge of laboratory practices and terminology.
Ability to read, write, speak fluently, and comprehend English.
A proven record of proactively and productively interacting with a team.
Candidates must be legally authorized to work in the country of employment without employer sponsorship.

Responsibilities

Direct the delivery of study milestones across multiple scientific teams within cost, time, and quality requirements.
Strategically lead direct and indirect reports, external partners, consultants, and financial budgets to ensure study milestones are delivered on time and within the defined scope of work.
Ensure assigned Project Directors lead and direct scientific work supporting assay analysis for non-regulated, GLP-regulated, GCP-regulated, and commercial diagnostic studies across Bioanalytical, Companion Diagnostic, Flow Cytometry, and Cell Biology teams.
Apply industry knowledge, customer requirements, and general business knowledge to adapt and implement strategic actions for the team.
Collaborate with senior scientific and operational leadership to continuously develop and improve business processes for cross-functional teams and ensure work is uniform, complete, and appropriately managed.
Set objectives for and manage multiple projects and ongoing work activities across PFM Specialty Lab teams.
Serve as the authoritative source of study information and lead study-level status reporting for each client.
Lead study teams and deliverables across functions, and manage and drive study timelines, budgets, and quality targets to meet or exceed business needs.
Ensure effective study-team scheduling, recordkeeping, and communications.
Define operational strategies, timelines, resourcing, and budget requirements for executing study plans within the defined 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 assessments of opportunities for the category.
Review direct reports' annual individual objectives and development plans, and conduct periodic performance evaluations in accordance with global or local corporate policy.
Ensure timely project execution and quality deliverables; facilitate handoff and kickoff meetings to identify potential risks and develop and communicate contingency plans with project teams.
Ensure project risks and contingencies that may affect delivery 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-of-work implementation and performance to date.
Identify unusual or significant problems during clinical trials and propose strategies to prevent or correct them.

Desired Qualifications

A Master's or PhD in Biology, Biochemistry, Immunology, Cell Biology, or 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.

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

Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.

Reasonable estimate of the current range

$147,300—$220,900 USD

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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [email protected].

Recruitment Fraud Warning: Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. Precision Medicine Group will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you believe you have been targeted by a recruitment scam, we encourage you to report the incident to your local law enforcement authorities, consumer protection agency, or relevant cybercrime reporting organization in your country. Please also notify us at [email protected] so we can investigate and take appropriate action.

Candidates must be legally authorized to work in the country of employment without employer sponsorship.

Reasonable estimate of the current range 147300 - 220900 USD

About the Company

Precision for Medicine

Global CRO for precision medicine trials

Precision For Medicine is a global clinical research organization (CRO) that helps life sciences companies run clinical trials from early to regulatory approval. It specializes in precision medicine, focusing on oncology, cell and gene therapy, and rare diseases. The company combines clinical trial services with specialty laboratory work and data sciences to improve speed, reduce costs, and increase the likelihood of success in bringing therapies to patients. It differentiates itself by integrating advanced technologies and data-driven biostatistics with specialized labs to support end-to-end trials across all stages. Its goal is to enable faster, more cost-efficient development of targeted therapies that meet regulatory requirements and reach patients in need.

Company size: 1,001-5,000
Company stage: Growth Equity (Venture Capital)
Total funding: $225M
Headquarters: Bethesda, MD
Founded: 2012

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