Summary
Overview
Work History
Education
Skills
Websites
Timeline
Generic

Shola Sulaimon

Santa Rosa,USA

Summary

Global Study Director with a proven track record in managing diverse research projects and leading cross-functional teams to success. Expertise in strategic planning and effective stakeholder communication consistently drives projects to successful completion. Extensive knowledge of research methodologies and data analysis techniques ensures high-impact outcomes and informed decision-making. Committed to advancing research initiatives that deliver measurable results and contribute to organizational growth.

Overview

19
19
years of professional experience

Work History

SR. CLINICAL RESEARCH PROGRAM MANAGER, Cardiac Surgery, Clinical Research & Medical Science

Medtronic PLC
01.2012 - 07.2025
  • Provided strategic planning and operational leadership to develop and implement program strategies and processes for a $1B global business—aligning program goals with corporate objectives and tracking progress against operating unit targets. Class I, II, III medical devices. Member of Clinical Leadership Team reporting to the VP CRMS.
  • Led 100 forecasting and Annual Operating Plan (AOP) management for a $5.5M operating budget, ensuring financial alignment with strategic objectives.
  • Led process improvement and efficiency efforts enabling project teams to generate and disseminate clinical evidence with the highest quality, timely delivery and cost effective. Increased closure of notified body queries by deficiency round 2.
  • Built strong relationships with stakeholders and cross-functional leaders across Clinical, Regulatory, R&D, Quality, and Marketing within the broader organization.
  • Conducted briefings with senior leadership on operations and strategic initiatives as well critical program outcomes.
  • As the EU-MDR Clinical Program Lead shaped strategy and direction for a 58-member global team supporting regulatory submissions and remediation activities for CE mark product approval and patient access in Europe. The team included clinical study managers, clinical research specialists, biostatisticians, and medical writers responsible for planning, clinical evidence generation, data analysis, and reporting.
  • As EU-MDR Clinical Program Lead, led strategy for a 58-member global team managing regulatory submissions and CE mark approval in Europe, working across clinical, biostatistics, and medical writing on study planning, evidence generation, analysis, and reporting.
  • The team generated documents consisting of CEP (Clinical Evidence Plan), CER (Clinical Evidence Report), PMCF (Post Market Clinical Follow up Plan) Plan, PMCF (Post Market Clinical Follow up Plan) Report, and SSCP’s (Summary of Safety and Clinical Performance).
  • Delivered 100% completion of clinical documentation supporting 53 EU-MDR Technical Files, resulting in European approval and CE certification of Class I, II, & III medical devices encompassing the following surgical valves, therapy extracorporeal, therapy, revascularization and surgical ablation, and blood management products.

MEDICAL WRITING MANAGER, Coronary & Structural Heart

CSH
07.2017 - 01.2021
  • Responsible for staff hiring, talent development & retention, performance evaluation, goal settings and employee feedback for Coronary & Renal Denervation and Cardiac Surgery & Structural Heart product portfolio, a $4B business.
  • Led a 9-member global team—including members in Europe and China—of experienced medical writers and contractors to disseminate clinical evidence for the Coronary and Renal Denervation product portfolio.
  • Trained diverse clinical teams on regulations from various geographies, including the European Union, Therapeutic Good Administration, and the China Food & Drug Administration.

PRINCIPAL MEDICAL WRITER

Coronary & Renal Denervation
05.2016 - 06.2017
  • Recruited to oversee the clinical evaluation and clinical evidence dissemination for Coronary & Renal Denervation product portfolio generating $1B/year, including clinical data analysis and scientific reports for regulatory submissions.
  • Compiled, analyzed, and condensed additional data such as complaint/vigilance data, risk management documentation, and scientific literature.
  • Engaged in post-market surveillance activities, including literature review, extracting data, and screening articles against inclusion/exclusion criteria.
  • Ensured compliance with regulatory guidance for CERs and essential safety and performance requirements outlined in Annex I of the Medical Device Directive 93/42/EEC, as per MEDDEV 2.7/1 Rev 4, MEDDEV 2.12, MEDDEV 2.4/1 Rev 9, and EN ISO 14155.

PRINCIPAL CLINICAL RESEARCH SPECIALIST

Coronary & Renal Denervation
01.2012 - 04.2016
  • Served as the Clinical Study Manager for PROTECT CA and Symplicity Heart Failure study, overseeing project schedules, dashboards, timelines, databases, CSRs, APRs, and study-specific SOPs from initiation to closeout.
  • Oversaw CRO service commitments in accordance with the contract while monitoring milestones and presenting project updates and key timelines to cross-functional team members and the CROs.
  • Provided critical guidance and assistance for process improvement initiatives supporting the operational launch of the Clinical CSH integration.

PRINCIPAL SCIENTIST, Coronary & Renal Denervation

Medtronic
01.2007 - 07.2011

ADJUNCT FACULTY

Sonoma State University (SSU)
08.2006 - 06.2007

ADJUNCT FACULTY

Santa Rosa Junior College (SRJC)
08.2006 - 06.2007

Education

Ph. D. - Clinical Sciences

University of Illinois
Urbana Champaign, IL

M.Sc. - Clinical Sciences

University of Illinois
Urbana Champaign, IL

Doctor of Veterinary Medicine (DVM) - undefined

University of Maiduguri

PMP - Professional Program in Project Management

UC Berkeley

Skills

  • Dynamic Clinical & Regulatory Program Leader with a 10 year track record of delivering global clinical programs, achieving EU-MDR approvals, and enabling market access for high-impact cardiovascular and surgical devices
  • Clinical and Regulatory Program Leader with over 10 years of experience managing global clinical programs, obtaining EU-MDR approvals, and facilitating market access for cardiovascular and surgical devices
  • Trusted Medical Device Executive known for guiding global teams across clinical research, medical writing, and biostatistics—consistently aligning clinical strategy with regulatory demands and organizational goals
  • Experienced Medical Device Executive skilled in leading international teams in clinical research, medical writing, and biostatistics, ensuring clinical strategy meets regulatory and organizational objectives
  • Clinical Operations Leader who builds structure in ambiguity, improves operational efficiency, and leads multimillion-dollar portfolios through strategic planning, stakeholder alignment, and high-performance team leadership
  • Clinical Operations Leader experienced in establishing structure, enhancing operational efficiency, and managing multimillion-dollar portfolios through strategic planning, stakeholder coordination, and team leadership
  • Regulatory Partnership Builder and Scientific Leader who cultivates trusted relationships with global health authorities to align clinical strategies with evolving regulatory expectations—accelerating approvals and enabling patient access worldwide
  • Regulatory expert and scientific leader who builds strong relationships with global health authorities to align clinical strategies with regulatory standards, speeding approvals and patient access worldwide

Timeline

MEDICAL WRITING MANAGER, Coronary & Structural Heart

CSH
07.2017 - 01.2021

PRINCIPAL MEDICAL WRITER

Coronary & Renal Denervation
05.2016 - 06.2017

SR. CLINICAL RESEARCH PROGRAM MANAGER, Cardiac Surgery, Clinical Research & Medical Science

Medtronic PLC
01.2012 - 07.2025

PRINCIPAL CLINICAL RESEARCH SPECIALIST

Coronary & Renal Denervation
01.2012 - 04.2016

PRINCIPAL SCIENTIST, Coronary & Renal Denervation

Medtronic
01.2007 - 07.2011

ADJUNCT FACULTY

Sonoma State University (SSU)
08.2006 - 06.2007

ADJUNCT FACULTY

Santa Rosa Junior College (SRJC)
08.2006 - 06.2007

M.Sc. - Clinical Sciences

University of Illinois

Doctor of Veterinary Medicine (DVM) - undefined

University of Maiduguri

PMP - Professional Program in Project Management

UC Berkeley

Ph. D. - Clinical Sciences

University of Illinois

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