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Guidehouse · 2 months ago

Program & Technical Advisor (Sr. Consultant/Managing Consultant/Associate Director)

McLean, VA

Full-time

Onsite

Senior Level, Lead/Staff, Director/Executive

$98K/yr - $163K/yr

5+ years exp

Guidehouse is a consulting firm specializing in strategy and transformation. The Program & Technical Advisor role involves providing specialized scientific and programmatic expertise in medical countermeasures research and development, particularly in response to public health emergencies.

AdviceConsultingManagement Consulting

No H1B

Security Clearance Required

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

Qualification

Statistical programmingClinical trials knowledgePharmaceutical product developmentTotal Life Cycle Cost (TLCC)Data analysisRegulatory policyQuality controlProcess optimizationMS Office proficiencyInterpersonal skillsTeam collaborationAttention to detailEffective communicationProblem-solving skills

Required

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

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

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

Preferred

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