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Job Family** **:

Strategy & Transformation Consulting

Travel Required** **:

Up to 25%

Clearance Required** **:

Ability to Obtain Public Trust

What You Will Do

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.

Job Description/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

What You Will Need:

**_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

What Would Be Nice to Have:

+ 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

\#LI-DNI

The annual salary range for this position is $98,000.00-$163,000.00. Compensation decisions depend on a wide range of factors, including but not limited to skill sets, experience and training, security clearances, licensure and certifications, and other business and organizational needs.

What We Offer** **:

Guidehouse offers a comprehensive, total rewards package that includes competitive compensation and a flexible benefits package that reflects our commitment to creating a diverse and supportive workplace.

Benefits include:

+ 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

About Guidehouse

Guidehouse is an Equal Opportunity Employer–Protected Veterans, Individuals with Disabilities or any other basis protected by law, ordinance, or regulation.

Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance including the Fair Chance Ordinance of Los Angeles and San Francisco.

If you have visited our website for information about employment opportunities, or to apply for a position, and you require an accommodation, please contact Guidehouse Recruiting at 1-571-633-1711 or via email at [email protected] . All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation.

All communication regarding recruitment for a Guidehouse position will be sent from Guidehouse email domains including @guidehouse.com or [email protected] . Correspondence received by an applicant from any other domain should be considered unauthorized and will not be honored by Guidehouse. Note that Guidehouse will never charge a fee or require a money transfer at any stage of the recruitment process and does not collect fees from educational institutions for participation in a recruitment event. Never provide your banking information to a third party purporting to need that information to proceed in the hiring process.

If any person or organization demands money related to a job opportunity with Guidehouse, please report the matter to Guidehouse’s Ethics Hotline. If you want to check the validity of correspondence you have received, please contact [email protected] . Guidehouse is not responsible for losses incurred (monetary or otherwise) from an applicant’s dealings with unauthorized third parties.

_Guidehouse does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Guidehouse and Guidehouse will not be obligated to pay a placement fee._