Regulatory Review Business Leader

Key Role:
Lead and develop a rapidly-growing segment of our federal health business in clinical data, bioinformatics, and regulatory review processes, tools, and systems. Lead client engagements, including marketing and proposal development, delivery, and execution, and provide leadership to a team of regulatory scientists, clinical data specialists, and data scientists. Support FDA clinical data and regulatory review leaders in providing tools and services to assess and analyze clinical study data; help medical reviewers leverage technology with analytical tools, processes, and approaches that facilitate regulatory review; and enhance data standards management and computing capabilities to support effective and efficient regulatory decision-making. Lead projects and programs, synthesize and analyze complex data, and work with the team to develop high-quality deliverables and actionable recommendations in a fast-paced environment. Coordinate with senior leaders to develop new business opportunities and author the technical approach for proposals.

Basic Qualifications:

-10+ years of experience with federal government consulting, including project delivery, client engagement, and relationship management

-5+ years of experience with leading teams in a collaborative, matrixed environment

-5+ years of experience with business development and capture

-Experience in working with FDA

-Knowledge of drug development and regulatory pathways

-Ability to obtain a security clearance

-BA or BS degree

Additional Qualifications:

-Experience with developing and implementing a business development plan to identify new opportunities, mature relationships, develop intellectual capital and proposals, and capture new business

-Ability to be a self-starter and thrive in a fast-paced consulting environment

-Experience with Clinical Data Interchange Standards Consortium (CDISC) data standards

-Experience with health or bio-informatics software tools, including SAS, R, JMP, or JMP Clinical

-Possession of excellent client facilitation and analytical skills

-Possession of excellent oral and written communication skills

-MA, MS, or MBA degree

-Project Management Professional (PMP) Certification

Clearance:

Applicants selected will be subject to a security investigation and may need to meet eligibility requirements for access to classified information.

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