OLUWAKEMI FAWOLE

Executive Summary & Candidate Overview

Oluwakemi (Kemi) Fawole is a seasoned clinical development physician with a wealth of experience in medical monitoring, study design, and clinical trial management. With expertise in overseeing the medical aspects of clinical trials across multiple therapeutic areas, Oluwakemi brings a strong foundation in drug safety, efficacy principles, and scientific guidance. Known for effective communication and the ability to collaborate with cross-functional teams, Oluwakemi is adept at ensuring protocol compliance and patient safety in dynamic environments.

Accomplishments and Key Skills

Oluwakemi's key accomplishments and skills include:

• Extensive experience in medical monitoring and oversight of clinical trials.

• Proficiency in study design, protocol development, and clinical trial management.

• Strong therapeutic knowledge across various disease areas.

• Exceptional communication skills, both verbal and written.

• Ability to multitask under tight deadlines and adapt quickly to change.

• Proficiency in utilizing clinical trial management software and data analysis tools.

Location and Travel

• Open to: On-site and remote roles.

• Remote Roles: Experienced in remote work and collaboration.

• Compensation Seeking: Open to discussing compensation details based on role and responsibilities.

• Position Seeking: Seeking senior-level roles in clinical development, medical monitoring, or drug safety within the pharmaceutical industry.

Work Experience

1. Senior Medical Director - Intercept Pharmaceuticals (2021 – Present)

   • Provide medical monitoring oversight for ongoing clinical trials and collaborate with cross-functional teams.

   • Lead management of vendors and ensure compliance with medical monitoring-related SOPs and regulations.

   • Contribute to continuous process improvement initiatives and support product strategy development.

2. Medical Director - Pharm-Olam (2020 – 2021)

   • Oversaw medical aspects of clinical trials and served as the medical monitor for assigned studies.

   • Provided scientific input for protocol development and safety reporting.

   • Supported business development efforts and contributed to client interactions.

3. Clinical Scientist (Medical Monitor) - PRA Health Sciences (2013 – 2020)

   • Accountable for scientific implementation of trials and medical monitoring activities.

   • Provided medical expertise for protocol development and reviewed safety and efficacy data listings.

   • Participated in client calls, bid defenses, and investigator meetings.

Education

• Doctor of Philosophy (Ph.D.) in Public Health Epidemiology from Walden University.

• Master of Public Health (M.P.H.) from Johns Hopkins University, Bloomberg School of Public Health.

• Bachelor of Medicine, Bachelor of Surgery (M.B.Ch.B.) from Olabisi Onabanjo University, Ogun State, Nigeria.