Drug Development SME

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

• 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