Contingent Upon Contract Award

Position Summary

SoftDev Incorporated is seeking a Senior Organizational Development Consultant / Executive Leadership Coach to support a potential federal contract with the U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Compliance.

This position will provide strategic implementation, organizational development, executive coordination, and leadership decision-support services for cross-office compliance priorities. The consultant will work with senior federal leaders to help translate complex operational, regulatory, and organizational inputs into actionable implementation frameworks, roadmaps, performance measures, and decision-support materials.

This is a key personnel position and is contingent upon contract award and customer approval.

Place of Performance

Work is expected to be performed primarily remote, with meetings or support activities held at FDA’s White Oak Headquarters in Silver Spring, Maryland, as required.

Key Responsibilities

The Senior Organizational Development Consultant / Executive Leadership Coach will support FDA Office of Compliance leadership by performing work such as:

• Providing strategic implementation and leadership coordination support for cross-office compliance initiatives.
• Facilitating structured engagement among senior leaders and component offices.
• Synthesizing complex, multi-office inputs into clear, decision-relevant information for executive leadership.
• Supporting leadership decision-making by developing actionable frameworks, options, summaries, and recommendations.
• Supporting enterprise alignment across offices by helping identify inconsistencies, implementation gaps, and areas requiring clarification.
• Developing shared reference materials, communication tools, and implementation guidance to support consistent execution.
• Designing and supporting centralized approaches for tracking milestones, deliverables, deadlines, interdependencies, and accountability.
• Assessing existing strategic and operational plans, procedures, workflows, and practices.
• Documenting and defining business processes to support improved execution and coordination.
• Developing baseline measurements to assess the effectiveness of strategic and operational plans.
• Assisting with prioritization of critical output, productivity, and outcome measures.
• Developing implementation roadmaps, performance measures, and progress-tracking tools.
• Applying organizational development, behavioral science, human factors, or neuroscience-informed approaches to leadership support, change management, and organizational execution.
• Supporting high-visibility, multi-stakeholder initiatives in a federal regulatory or comparable mission-driven environment.
• Maintaining professional, timely, and effective communication with government leadership, project leads, and stakeholders.

Required Qualifications

Candidates must meet the following minimum qualifications:

• Master’s degree in organizational development, public administration, industrial-organizational psychology, business administration, human-systems integration, or a closely related field.
• At least 10 years of demonstrated experience in management consulting, organizational development, or strategic implementation support.
• At least 5 years of senior-level experience supporting complex organizational, executive, or enterprise-level initiatives.
• Demonstrated experience with enterprise-level program coordination across multiple organizational units.
• Demonstrated experience supporting execution planning and milestone management for high-visibility, multi-stakeholder initiatives.
• Demonstrated experience facilitating executive-level decision-making and synthesizing complex information for senior leaders.
• Verifiable experience coordinating cross-functional initiatives and supporting leadership execution of strategic priorities.
• Demonstrated, verifiable application of neuroscience or behavioral science principles to organizational strategy, change management, leadership support, or complex institutional settings.
• Direct experience supporting FDA, CDER, or a comparable federal regulatory agency.
• Familiarity with compliance, enforcement, regulatory oversight, or similar federal mission functions.
• At least one recognized professional certification relevant to the scope of work, such as:
  • Project Management Professional (PMP)
  • Certified Management Consultant (CMC)
  • NeuroLeadership Institute certification or equivalent applied neuroscience credential
  • Organizational Development Certified Professional (ODCP)
  • Registered Organization Development Consultant (RODC)
  • Other equivalent credential demonstrating professional standing in strategic implementation, organizational development, leadership coaching, or applied neuroscience

Preferred Qualifications

The following qualifications are strongly preferred:

• Degree coursework, research, publications, presentations, or formal training in cognitive neuroscience, behavioral neuroscience, organizational neuroscience, human factors, applied neuroscience, or behavioral science.
• Published research, white papers, presentations, or case studies demonstrating neuroscience-informed or behavioral-science-informed interventions in organizational settings.
• Experience supporting FDA, CDER, HHS, or other federal health, regulatory, compliance, inspection, enforcement, or oversight organizations.
• Experience working with senior executives in a federal agency environment.
• Experience developing decision-support frameworks, implementation roadmaps, performance measures, milestone trackers, briefing materials, and executive-level communications.
• Experience supporting organizational change, enterprise alignment, leadership coaching, strategic planning, process improvement, or governance design.
• Strong understanding of how to support sensitive, high-priority initiatives requiring coordination, discretion, accountability, and rapid execution.

Required Skills and Competencies

The ideal candidate will demonstrate:

• Executive presence and the ability to work effectively with senior government leaders.
• Strong facilitation, coaching, and stakeholder engagement skills.
• Ability to translate complex regulatory, operational, and organizational information into clear recommendations.
• Strong analytical, writing, briefing, and communication skills.
• Ability to design practical frameworks, roadmaps, trackers, and performance measures.
• Ability to work independently while coordinating effectively with leadership, project teams, and stakeholders.
• Strong judgment, discretion, and professionalism in handling sensitive leadership and organizational matters.
• Ability to operate in fast-moving, high-visibility federal environments with multiple stakeholders and competing priorities.

Security and Onboarding Requirements

The selected candidate must be able to complete FDA security onboarding requirements before beginning billable work. Candidate acceptance is subject to customer review and approval.

Employment Status

This position is contingent upon contract award, funding, and customer approval of key personnel.

About SoftDev Incorporated

SoftDev Incorporated is a woman-owned, HUBZone-certified small business with more than 26 years of experience supporting federal health, data, program management, and technology missions. SoftDev’s mission is to Improve Lives through Health IT, and we support federal customers through disciplined program execution, stakeholder coordination, data-driven decision-making, and mission-focused delivery.

How to Apply

Interested candidates should submit a resume that clearly demonstrates how their education, certifications, applied neuroscience or behavioral science expertise, federal regulatory experience, and senior organizational development experience align with the requirements of this role.

Candidates are encouraged to include examples of relevant publications, case studies, presentations, certifications, implementation roadmaps, executive facilitation work, leadership coaching experience, or strategic implementation support.