Associate Medical Director, Medical Affairs Resume

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Associate Medical Director, Medical Affairs Resume Desmond Rahman Associate Medical Director, Medical Affairs (630) 555-4821 desmond.rahman@example.com linkedin.com/example/desmondrahman Oak Brook, IL 60523 STRENGTHS Clinical Judgment Reviews product findings in patient context, then gives teams a clear medical recommendation grounded in laboratory practice. Safety Assessment Complaint patterns, MDRs, and surveillance signals receive focused review. Colleagues rely on practical judgment when patient impact is unclear. Cross Functional Work R&D, Quality, Regulatory, and Clinical teams gained a shared view of risk through concise medical assessments and discussion. Evidence Translation Turns complex performance data and literature into useful summaries. Leaders can act without losing important clinical context. Laboratory Expertise Hospital laboratory experience shaped product recommendations around real workflows, specimen issues, clinicians, and patient care decisions. SKILLS Medical Affairs Laboratory Medicine Clinical Judgment Diagnostic Products Design Control Clinical Research Clinical Evidence Risk Management Post Market Surveillance Medical Device Reports Health Hazard Evaluations Benefit Risk Analysis Patient Safety FDA Interactions Regulatory Submissions LANGUAGES English Native 40 Spanish Intermediate 20 MY CAREER 14.8 Years Associate Medical Director, Medical Affairs at Meridian Clinical Diagnostics (4.7 Years) Medical Affairs Director, Laboratory Diagnostics at Summit Reference Laboratories (2.7 Years) Senior Medical Affairs Manager at Lakeview Health Diagnostics (2.7 Years) Clinical Laboratory Physician at Prairie University Medical Center (2.9 Years) Clinical Laboratory Medicine Fellow at Riverside Academic Hospital (1.9 Years) SUMMARY Associate Medical Director and MD trained physician with 15 years of healthcare and diagnostic experience, including more than 10 years across clinical laboratory medicine and medical affairs . Provides clinical judgment across diagnostic product development, design control, clinical evidence, patient safety, medical risk management, regulatory submissions, and post market surveillance . Reviews complaints, adverse events, Medical Device Reports, Health Hazard Evaluations , benefit risk analyses, and product performance findings to guide patient focused decisions. Partners with R&D, Clinical Affairs, Regulatory Affairs, Quality, and Product Development teams on clinical studies, corrective actions, commercialization, and FDA interactions. Communicates medical assessments clearly with technical leaders, clinicians, customers, and business stakeholders while balancing clinical value, regulatory compliance, safety, and operational needs. EXPERIENCE Associate Medical Director, Medical Affairs Meridian Clinical Diagnostics January 2022 - Present Chicago, IL Leads medical oversight for diagnostic products across development, commercialization, safety monitoring, and post market decision making. Advises senior leaders and cross functional teams on clinical evidence, product performance, risk, and regulatory implications. Led complaint and MDR trend reviews, separating isolated cases from signals requiring formal medical risk assessment. Authored Health Hazard Evaluations and benefit risk analyses supporting Quality corrective action decisions. Guided design control teams on clinical requirements, laboratory workflows, and patient care implications. Reviewed study protocols and performance data, identifying meaningful endpoints and evidence gaps before regulatory milestones. Presented medical assessments to leadership, physicians, laboratory customers, and regulatory stakeholders during product decisions. Integrated surveillance findings, adverse events , and clinical evidence into lifecycle decisions supporting patient safety and compliance. Medical Affairs Director, Laboratory Diagnostics Summit Reference Laboratories April 2019 - December 2021 Evanston, IL Directed medical affairs support for laboratory instruments and assays used in hospital and reference laboratory settings. Connected clinical performance, laboratory workflows, post market findings, regulatory evidence, and safe use decisions across product teams. Evaluated post market data and laboratory complaints against intended use and clinical workflows. Partnered with clinical and regulatory specialists on study designs and submission evidence for authorities. Created medical assessment templates that improved consistency while preserving case specific clinical judgment . Assessed patient, provider, and laboratory effects during corrective action recommendations and mitigation reviews. Represented Medical Affairs at customer and scientific meetings focused on diagnostic testing practices . Prepared evidence summaries linking product performance findings with clinical significance and safe use decisions. Senior Medical Affairs Manager Lakeview Health Diagnostics July 2016 - March 2019 Downers Grove, IL Managed medical review for in vitro diagnostic products , connecting laboratory practice with product risk management, surveillance, clinical evidence, and regulatory needs. Mentored specialists and supported cross functional investigation of safety concerns. Reviewed complaints and adverse event information, identifying cases requiring MDR evaluation or investigation. Supported Health Hazard Evaluations through literature review, exposure assessment, and clinical risk reasoning. Contributed medical input during design reviews, identifying foreseeable clinical use risks and mitigations. Translated clinical data and scientific literature into evidence summaries for regulatory and post market activities. Mentored specialists on structured clinical assessment, documentation quality , and cross functional communication. Connected product performance records with laboratory practice to clarify patient impact and corrective priorities. Clinical Laboratory Physician Prairie University Medical Center July 2013 - June 2016 Maywood, IL Provided physician oversight in a hospital laboratory serving chemistry, hematology, infectious disease, and related diagnostic areas. Advised clinicians and laboratory teams on result interpretation, quality events, testing workflows, and new methods. Interpreted complex laboratory findings with treating clinicians, connecting results with patient context and follow up. Reviewed testing discrepancies and significant events, determining potential patient impact for corrective investigations. Advised laboratory teams on specimen considerations, test utilization, and workflow changes affecting result quality. Evaluated new diagnostic methods and instrumentation through clinical performance and operational fit reviews. Presented laboratory medicine topics to clinicians and technical staff, strengthening diagnostic communication. Supported hospital laboratory decisions across chemistry, hematology, infectious disease, and related services. Clinical Laboratory Medicine Fellow Riverside Academic Hospital July 2011 - June 2013 Peoria, IL Completed supervised clinical laboratory medicine training across core disciplines, building practical expertise in diagnostic testing, quality systems, clinical interpretation, and laboratory incident review. Prepared scientific work for physicians and technical teams. Reviewed complex laboratory cases with faculty physicians and prepared evidence based interpretations. Evaluated assay performance and quality control findings, distinguishing analytical variation from clinical concern. Supported supervised investigations of laboratory incidents and specimen issues, documenting potential clinical effects. Prepared scientific reviews and conference presentations on diagnostic methods and emerging laboratory evidence. Communicated diagnostic findings with laboratory professionals and clinicians across technical and medical perspectives. Developed foundational experience in laboratory quality systems, testing practices, and clinical consultation. PROJECTS Diagnostic Safety Signal Program 2024 Built a structured review approach for complaints, adverse events, MDRs, and surveillance findings, helping teams distinguish emerging patient safety concerns from isolated product issues. Clinical Evidence Review Framework 2021 Standardized medical opinions, evidence summaries, and benefit risk reviews for diagnostic products, giving Quality and Regulatory teams clearer clinical rationale for decisions. LEADERSHIP & AWARDS Physician Member, Medical Risk Review Council, 2022 to Present. Provides clinical perspective on product safety and risk decisions. Faculty Contributor, Clinical Laboratory Safety Education Committee, 2014 to 2016. Shared laboratory safety education with clinical and technical audiences. Board Certification, Clinical Pathology, 2014. Recognized advanced expertise in laboratory medicine and diagnostic interpretation. EDUCATION Doctor of Medicine University of Illinois College of Medicine GPA: 0 2011 Chicago, IL Coursework: Clinical medicine, pathology, laboratory medicine, patient safety Bachelor's Degree in Clinical Laboratory Science Northern Illinois University GPA: 0 2007 DeKalb, IL Coursework: Clinical chemistry, hematology, microbiology, diagnostic testing CERTIFICATIONS Illinois Physician and Surgeon License 2011 Board Certification, Clinical Pathology 2014 TECHNICAL SKILLS Clinical Laboratory Practice: Laboratory medicine, Clinical pathology, Diagnostic testing Diagnostic Products: In vitro diagnostics, Assays, Laboratory instruments Medical Risk Review: Health Hazard Evaluations, Medical risk assessments, Benefit risk analyses Safety Surveillance: Post market surveillance, Adverse events, Safety signals Device Reporting: Medical Device Reports, MDR review, Complaint assessment Clinical Evidence: Clinical evidence summaries, Scientific reviews, Medical opinions Product Development: Design control, Clinical requirements, Product performance Clinical Research: Study protocols, Clinical endpoints, Performance data Regulatory Affairs: FDA interactions, Regulatory submissions, International health authorities Quality Systems: Corrective actions, Quality investigations, Risk mitigation Laboratory Operations: Hospital laboratories, Reference laboratories, Healthcare workflows Scientific Communication: Leadership presentations, Customer meetings, Conference presentations SKILLS Medical Affairs Laboratory Medicine Clinical Judgment Diagnostic Products Design Control Clinical Research Clinical Evidence Risk Management Post Market Surveillance Medical Device Reports Health Hazard Evaluations Benefit Risk Analysis Patient Safety FDA Interactions Regulatory Submissions PROFESSIONAL AFFILIATIONS Medical Risk Review Council, Physician Member, 2022 to Present Clinical Laboratory Safety Education Committee, Faculty Contributor, 2014 to 2016 Medical Affairs and laboratory medicine professional community, clinical evidence and patient safety focus LANGUAGES English (Native) Spanish (Intermediate) ADDITIONAL INFORMATION Work Status : Authorized to work in United States. No sponsorship required. ADDITIONAL INFORMATION Work Status : Authorized to work in United States. No sponsorship required. REFERENCES AVAILABLE ON REQUEST

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