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Drug Development SME

Guidehouse • Silver Spring, MD • 16h ago

Job Family :

IT Project Management (Digital)

Travel Required :

Up to 10%

Clearance Required :

Ability to Obtain Public Trust

What You Will Do :

To provide scientific and technical guidance to Applied Regulatory Science management leadership, scientists and project teams.

Help interpret clinical and pharmaceutical data and provide value added support to the regulatory teams.

Supervise guide bioanalytical and pharmacokinetic scientist in Applied Regulatory Science division

Support the acquisition of a Laboratory Information System (LIMS) and ensure the inclusion of quality assurance aspects and division workflows.

What You Will Need :

Master's degree in biology, pharmaceutical sciences or related discipline

Extensive knowledge in preclinical & clinical development.

Minimum of 10 years of Experience

Solid hands-on experience in pharmacokinetics (small & large molecules), Pharmacokinetic/Pharmacodynamic modeling & Simulations, bioanalysis, drug metabolism, translational medicine, and drug delivery and formulation.

Demonstrated track record in analyzing and interpreting complex scientific data.

Broad knowledge and proven supervisory skills.

Exceptional oral and written communication skills and ability to network and build consensus within a multi-disciplinary organization.

Drug regulatory experience is desired, particularly in regulatory science research.

What Would Be Nice To Have :

Ph.D. degree in biology, pharmaceutical sciences, or related discipline

20 + years of experience in regulatory agency and pharmaceutical industry.

The annual salary range for this position is $171,000.00-$285,000.00. 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

Parental Leave

401(k) Retirement Plan

Group Term Life and Travel Assistance

Voluntary Life and AD&D Insurance

Health Savings Account, Health Care & Dependent Care Flexible Spending Accounts

Transit and Parking Commuter Benefits

Short-Term & Long-Term Disability

Tuition Reimbursement, Personal Development, Certifications & Learning Opportunities

Employee Referral Program

Corporate Sponsored Events & Community Outreach

Care.com annual membership

Employee Assistance Program

Supplemental Benefits via Corestream (Critical Care, Hospital Indemnity, Accident Insurance, Legal Assistance and ID theft protection, etc.)

Position may be eligible for a discretionary variable incentive bonus

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 RecruitingAccommodation@guidehouse.com . 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 guidehouse@myworkday.com . 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 recruiting@guidehouse.com . 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.

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