Nathifa Young
Chicago,IL
Summary
Results-driven Clinical Affairs Leader with expertise in managing clinical trials, ensuring regulatory compliance, and enhancing patient safety. Skilled in budget management and process improvement, delivering successful project outcomes through strategic problem-solving and cross-functional collaboration.
Overview
12
12
years of professional experience
Work History
DIRECTOR, CLINICAL AFFAIRS
Abbott
Abbott Park, USA
01.2022 - 02.2026
- Directed design and implementation of clinical trials, ensuring safety and efficacy.
- Oversaw organizational clinical research initiatives to achieve strategic goals.
- Collaborated with external research organizations and stakeholders to ensure successful and timely execution of clinical trials.
- Managed budget allocations and resource planning for projects across departments to align with organizational goals.
- Implemented processes that streamlined workflows, enhancing team productivity and effectiveness.
- Negotiated agreements with external partners such as contractors or consultants.
- Identified and evaluated potential research opportunities and partnerships.
- Provided scientific and technical expertise to clinical research team.
- Presented research findings to internal and external stakeholders effectively.
- Communicated with regulatory agencies, participating in audits and inspections.
ASSOCIATE DIRECTOR, CLINICAL OPERATIONS
Abbott
Abbott Park, USA
01.2020 - 01.2022
- Oversaw creation and presentation of clinical trial progress reports to senior management, enhancing visibility into project status.
- Ensured transparency in reporting to facilitate informed decision-making among key stakeholders.
- Defined organizational design and skill delineation, establishing technology requirements and streamlining strategic sourcing.
- Developed job descriptions and capabilities for clinical affairs and operations functions, aligning roles with strategic objectives.
CLINICAL RESEARCH MANAGER, CLINICAL AFFAIRS
Abbott
Abbott Park, USA
01.2019 - 01.2020
- Managed operations by hiring and training diverse staff of 20 Clinical Research Associates (CRAs), enhancing team capability.
- Implemented strategies to improve participant recruitment and retention in clinical trials.
- Developed training materials for clinical research staff on GCPs, ICH guidelines, and other relevant topics.
- Coached CRAs on career development and provided growth opportunities, fostering a supportive work environment.
- Designed and implemented quality-related training programs for CRAs, ensuring high standards and continuous improvement.
- Developed direct reports through regular feedback, instruction, mentoring, coaching, and performance reviews, enhancing their professional growth.
- Accountable for performance and work output of direct reports, ensuring alignment with organizational goals and quality standards.
- Prepared detailed case report forms outlining data collection requirements for each trial participant.
PROJECT MANAGER, CLINICAL AFFAIRS
Abbott
Abbott Park, USA
01.2017 - 01.2019
- Managed clinical study timelines and budgets with project management tools to ensure adherence to financial and scheduling targets.
- Developed clinical execution strategies by integrating feedback from relevant departments to enhance study effectiveness.
- Ensured compliance with study protocols, FDA regulations, and ICH/GCP requirements for regulatory adherence.
- Supervised design of protocols, case report forms, data management, and monitoring plans to ensure thorough study documentation.
- Facilitated site selection through strategic meetings with departments and individuals.
- Oversaw internal specimen collection monitoring programs and external collection efforts for R&D studies.
- Provided insights during executive leadership and steering committee meetings to support informed strategic decision-making.
MANAGER, CLINICAL AFFAIRS
Sysmex America, Inc.
Lincolnshire, USA
01.2014 - 01.2017
- Led team of clinical research associates to meet project deliverables and support business goals.
- Oversaw implementation of clinical research strategies, ensuring alignment with objectives.
- Led development of instructions for use and risk management activities as clinical lead.
- Executed clinical studies in compliance with investigational plans and regulations.
- Partnered with business and research teams to identify and fulfill clinical evidence needs for products.
- Developed patient recruitment strategies, assessing operational feasibility for study objectives.
- Worked with data management and statistical teams to review data analysis and interpretation.
- Developed and refined standard operating procedures to strengthen quality systems.
Education
MASTER OF BUSINESS ADMINISTRATION - FINANCIAL ANALYSIS CONCENTRATION
Keller Graduate School of Management
Chicago, ILChicago, IL
BACHELOR OF SCIENCE - MEDICAL TECHNOLOGY
University of Illinois At Chicago
Chicago, ILChicago, IL
CLINICAL ROTATIONS/INTERNSHIP -
Ann & Robert H. Lurie Children's Hospital of Chicago formerly Children's Memorial Hospital
ChicagoChicago
Skills
- Strategic problem-solving
- Cross-functional leadership
- Budget and resource management
- Long-range planning
- Conflict resolution
- Adaptability and quality improvement
- Patient and subject safety
- Regulatory compliance
- Process improvement
- Ethical judgment and cultural competence
- Laboratory analysis in chemistry, immunohematology, hematology, and microbiology
- Phlebotomy expertise
Certifications/Affiliations
- The Strategy of Leadership: Unleashing the Power of Influence - Kellogg School of Management at Northwestern University
- Abbott Leading with Impact
- Abbott Leading Through Financial Excellence
- Certified Lean Six Sigma Yellow Belt
- Sysmex Management Academy Certification - Lake Forest Graduate School of Management
- Collaborative Institutional Training Initiative - Human Subject Research Training
- Certified Clinical Research Associate - Association of Clinical Research Professionals (ACRP)
- American Society of Clinical Pathologists (ASCP) Associate Member Board of Registry - Registrant MT-199716
- HIV/AIDS Instructor- American Red Cross of Greater Chicago
- Investigator Education Certification - University of Illinois at Chicago
- National Black MBA Association - Member
Clinical Rotations Internship
Ann & Robert H. Lurie Children's Hospital of Chicago formerly Children's Memorial Hospital, Chicago, IL
Timeline
DIRECTOR, CLINICAL AFFAIRS
Abbott
01.2022 - 02.2026
ASSOCIATE DIRECTOR, CLINICAL OPERATIONS
Abbott
01.2020 - 01.2022
CLINICAL RESEARCH MANAGER, CLINICAL AFFAIRS
Abbott
01.2019 - 01.2020
PROJECT MANAGER, CLINICAL AFFAIRS
Abbott
01.2017 - 01.2019
MANAGER, CLINICAL AFFAIRS
Sysmex America, Inc.
01.2014 - 01.2017
MASTER OF BUSINESS ADMINISTRATION - FINANCIAL ANALYSIS CONCENTRATION
Keller Graduate School of Management
BACHELOR OF SCIENCE - MEDICAL TECHNOLOGY
University of Illinois At Chicago
CLINICAL ROTATIONS/INTERNSHIP -
Ann & Robert H. Lurie Children's Hospital of Chicago formerly Children's Memorial Hospital