Associate Director)

Guidehouse•Tysons Corner, VA

14d•$98,000 - $163,000

About The Position

The Program & Technical Advisors delivers specialized scientific and programmatic expertise in areas related to medical countermeasures research and development. These services are essential for advancing efforts in biotechnology and biopharmaceuticals, particularly in addressing public health impacts from chemical, biological, radiological, and nuclear threats, as well as pandemic influenza and emerging infectious diseases. In this role, you will provide expert advisory and technical support for federal public health emergency responses, particularly related to medical countermeasures. You will lead scientific and statistical efforts including data analysis, modeling, and reporting, while offering ad hoc support to client projects. As a subject matter expert, you’ll contribute to program development, evaluation, and strategic planning, including drafting technical documents and participating in market research and technical evaluation panels. You’ll also advise on clinical, regulatory, and manufacturing aspects of medical product development, ensuring alignment with the client’s mission and lifecycle cost strategies. As a program and technical advisor, you will be a critical member of project teams, helping our clients solve complex public health and business challenges from strategy through execution. You will have an opportunity to deepen your specialized knowledge and skills, with room for long-term professional growth and career development within the firm. We are looking for candidates who are self-motivated, outcomes oriented, and capable and willing to develop solutions on their own and collaboratively as part of a team of highly skilled professionals.

Requirements

Programmatic/Technical Advisor – Senior Consultant Level
Bachelor’s degree in biological, chemical, life sciences (immunology, molecular biology, biochemistry, microbiology or similar), or physical science (engineering, physics, computer science, or similar) OR Post graduate degree in medicine or pharmacy with bachelor’s degree in computer science, statistics or related field and extensive knowledge in clinical trials and epidemiological research, including 3 years of direct statistical programming experience OR Bachelor's degree in chemistry, engineering, or biology including 5 years of direct experience in pharmaceutical facility architecture and application in commercial building construction or a degree in business with experience in pharmaceutical product development and Total Life Cycle Cost (TLCC) management
Minimum 5 years of relevant industry experience related to a combination of the following areas: medicinal chemistry; preclinical development (animal models, pharmacology, toxicology); advanced clinical development (medical officers, immunologists, clinical operations); analytical product testing and testing development; quality control; clinical and/or regulatory policy; and/or manufacturing (chemistry, manufacturing, and controls); process development, process scale-up and process optimization; device development and manufacturing, reliability engineering, Software, Assay chemistry, microbiology, virology, immunology
Programmatic/Technical Advisor – Managing Consultant Level
Graduate or advanced degree in biological and/or chemical sciences and/or relevant postdoctoral experience OR Application of advanced degree in medicine or pharmacy with master’s degree in computer science, statistics, or related field and extensive knowledge in clinical trials and epidemiological research, including 5 years of direct statistical programming experience OR Bachelor's degree in chemistry, engineering, or biology including 8 years of direct experience in pharmaceutical facility architecture and application in commercial building construction or a degree in business with experience in pharmaceutical product development and Total Life Cycle Cost (TLCC) management
Minimum 8 years of relevant industry experience related to a combination of the following areas: medicinal chemistry; preclinical development (animal models, pharmacology, toxicology); advanced clinical development (medical officers, immunologists, clinical operations); analytical product testing and testing development; quality control; clinical and/or regulatory policy; and/or manufacturing (chemistry, manufacturing, and controls); process development, process scale-up and process optimization; device development and manufacturing, reliability engineering, Software, Assay chemistry, microbiology, virology, immunology
Programmatic/Technical Advisor – Associate Director
Doctoral degree in biological and/or chemical sciences with relevant postdoctoral experience OR Application of doctoral degree(s) in medicine or pharmacy with advanced degrees in computer science, statistics, or related fields and extensive knowledge and experience in clinical trials and epidemiological research, including 7 years of direct statistical programming experience OR Bachelor's degree in chemistry, engineering, or biology including 10 years of direct experience in pharmaceutical facility architecture and application in commercial building construction or a degree in business with experience in pharmaceutical product development and Total Life Cycle Cost (TLCC) management
Minimum 12 years of relevant industry experience related to a combination of the following areas: medicinal chemistry; preclinical development (animal models, pharmacology, toxicology); advanced clinical development (medical officers, immunologists, clinical operations); analytical product testing and testing development; quality control; clinical and/or regulatory policy; and/or manufacturing (chemistry, manufacturing, and controls); process development, process scale-up and process optimization; device development and manufacturing, reliability engineering, Software, Assay chemistry, microbiology, virology, immunology

Nice To Haves

Direct experience supporting organizations related to Advanced Research and Development (ARD) and Medical Countermeasures (MCM)
Extensive knowledge of FDA/ICH guidelines and CDISC data standards
Experience in pharmaceutical industry regulatory affairs and/or quality assurance and/or quality control
Direct experience in pharmaceutical facility architecture
Ability to think strategically while delivering tactically, with a keen attention to detail
Ability to work effectively in a dynamic, fast-paced environment
Strong interpersonal skills and ability to effectively communicate with stakeholders at all levels in an organization; ability to develop visually appealing and impactful communication materials
Demonstrated ability to collaborate and contribute as a team member, understanding personal and team roles, contributing to a positive working environment by building relationships with team members, and proactively seeking guidance, clarification, and feedback
Experience prioritizing and handling multiple tasks, researching and analyzing pertinent client, industry and technical matters, and utilizing problem-solving skills to achieve desired outcomes
Advanced proficiency with MS Office tools: Word, Excel, PowerPoint

Responsibilities

Provide expertise and advisory support related to medical countermeasures being utilized for federal public health emergency responses
Provide advance services including but not limited to data cleaning, data transfers, data quality control, data integration and validation, data analysis and report package preparation, statistical simulation, statistical toolbox for advanced data modelling, tabulation, and visualization; provide ad hoc statistical support to client projects under the guidance of client statisticians
Act as an SME on scientific subjects; contribute subject matter expertise to programs with technical or program management expertise; and facilitate meetings as directed
Provide advisory support to client Program Division(s); Prepare draft work statements (SOW, SOO, PWS IGCE & Cost Estimates) for solicitations [Request for Information (RFIs), Request for Proposals (RFPs), Sources Sought Notices (SSN), et al]
Direct tasks and lead technical efforts and scientific projects
Serve as advisor(s) on Technical Evaluation Panels (TEPs) to include white papers/market research abstracts, technical proposals, and budget proposals
Participate on Program Coordination Teams (PCTs); provide assessments, recommendations, and guidance as well as educational material to PCT and COR, as needed
Participate in strategic discussions, working with USG, in building new program areas in alignment with client’s mission space
Provide recommendations for project development level portfolio management and oversight as required
Provide recommendations or advise on development, implement, and consciously improve Total Life Cycle Cost (TLCC) efforts, and participate in Market Research efforts
Analyze protocols, study reports, regulatory documents, presentations, proposals, and related documents, as needed
Additional duties related to programmatic support maybe assigned
Build and sustain meaningful relationships with clients and colleagues
Contribute to positive, inclusive team culture and collaborative working environment
Understand and use firm capabilities, solutions, and methodologies

Benefits

Medical, Rx, Dental & Vision Insurance
Personal and Family Sick Time & Company Paid Holidays
Position may be eligible for a discretionary variable incentive bonus
Parental Leave and Adoption Assistance
401(k) Retirement Plan
Basic Life & Supplemental Life
Health Savings Account, Dental/Vision & Dependent Care Flexible Spending Accounts
Short-Term & Long-Term Disability
Student Loan PayDown
Tuition Reimbursement, Personal Development & Learning Opportunities
Skills Development & Certifications
Employee Referral Program
Corporate Sponsored Events & Community Outreach
Emergency Back-Up Childcare Program
Mobility Stipend