Summary
Overview
Work History
Education
Skills
Board Certifications
State Medical Board Licenses
Fellowship Training
Residency Training
Professional Memberships
Clinical Trial Experience - Indications
Timeline
Generic

Suzanne Mela, MD

Highland Beach,florida

Summary

Highly motivated and enthusiastic physician, board-certified in Allergy, Asthma, and Immunology, with extensive industry experience in allergy, respiratory medicine and the Inflammatory space. Eager to excel in a Clinical Development leadership role to build key therapeutic area programs to drive the successful market launch of innovative drugs.

Overview

17
17
years of professional experience

Work History

Senior Medical Director

Fortrea
06.2023 - 10.2024
  • Company Overview: A mid-sized leading Contract Research Organization (CRO).
  • I served as the Senior Global Medical Director for Phase I-IV allergy and respiratory clinical trials for Adults and Pediatrics.
  • Leveraging my extensive expertise as a Principal Investigator, Direct Patient Care Physician, and Global Medical Monitor, I was responsible for the successful clinical trial design and execution across multiple therapeutic indication areas including asthma, COPD, ILD, PH, atopic dermatitis, CRS with NP and rare diseases.
  • My role was pivotal in expanding our portfolio while brokering new partnerships with both small biotechnology sponsors and large pharmaceutical companies while utilizing my expertise to spearhead their clinical development programs in these therapeutic areas.
  • As the key medical expert on several clinical development programs, I provided critical medical input to FDA and regulatory authorities including IND and BLA submissions, ensuring the accuracy and completeness of regulatory documents.
  • As a key therapeutic area expert, I supported the development of data-driven and patient-centered solutions that have contributed to the advancement of medical research through clinical trial design and execution through dynamic medical monitoring for late phase clinical trials.
  • My responsibilities in medical monitoring were extensive, encompassing protocol design and development, contributions to the Informed Consent Form (ICF), medical data review, pharmacovigilance, review of protocol deviations, development of a medical monitoring plan, medical contribution to the Electronic Case Report Form (ECRF) design, engagement in marketing strategies for recruitment and retention, medical contributions to regulatory documents, determination of eligibility criteria, promotion of the use of AI platforms for innovative safety trend tracking, CSR medical reviews, site support, therapeutic area and protocol training of sites, Principal Investigator (PI) and internal study teams, presentation at Investigator Meetings and Congresses.
  • My comprehensive approach ensured that our clinical trials were scientifically rigorous, ethically sound, and patient-focused, ultimately contributing to the collection of high-quality data, patient safety and the advancement of medical knowledge.
  • In addition, I developed individual study risk review criteria and innovative monitoring strategies to drive the successful completion of numerous clinical trials.
  • A key aspect of my role was identifying key clinical trial sites and building relationships with Principal Investigators (PIs), Key Opinion Leaders (KOLs), and other key stakeholders.
  • I worked collaboratively with cross-functional teams in a global matrix environment to ensure the right sites were selected by leveraging my relationships with KOLs and PIs.
  • As a seasoned Senior Global Medical Director, I demonstrated exceptional leadership in overseeing the medical aspects of clinical trials, guiding both the medical teams and global cross-functional clinical trial teams to achieve the highest standards of scientific rigor and ethical conduct.
  • My expertise in medical affairs has been instrumental in shaping the strategic direction of our clinical research initiatives and monitoring strategies, ensuring that they are aligned with the evolving landscape of medical science as well as both the needs of our patients and sponsor pharmaceutical companies.
  • One of my innovative accomplishments at Fortrea was the development of the 'Ambassador Program.' This program was designed to take a personalized approach in building our site network database while strengthening relationships with study sites, PIs, and Key Opinion Leaders in therapeutic indication areas.
  • The Ambassador Program allowed us to build the necessary platform for both clinical trial support and success for respiratory programs, ensuring a robust and reliable network of sites and experts to build a successful foundation for clinical trial success.
  • By continuously leveraging my experience as a Principal Investigator, Direct Care Physician, and Global Medical Monitor, I successfully identified and selected optimal clinical trial sites.
  • I provided clinical trial education to healthcare professionals in evidence-based medicine and served as a keynote medical instructor in relevant therapeutic areas such as respiratory, allergy, Immunology, and the inflammatory space.
  • As a Senior Medical Director, I have led end-to-end development strategies with a particular emphasis on late-stage clinical programs, ensuring alignment with regulatory requirements, commercial objectives, and evolving patient needs.
  • My ability to translate scientific and medical insights into actionable development plans was instrumental in expanding therapeutic programs in high-impact therapeutic areas, particularly within atopic dermatitis, allergy, Immunology and respiratory Medicine.
  • I played a pivotal role in progressing assets from proof-of-concept through pivotal Phase III trials, driving regulatory strategy, protocol design, and cross-functional execution across clinical operations, regulatory, and medical affairs.
  • My leadership facilitated data-driven decision-making for pipeline prioritization and asset lifecycle management, resulting in accelerated timelines and optimized resource allocation.
  • Additionally, I established strategic collaborations with both emerging biotech innovators and global pharmaceutical companies, enabling joint development efforts and expanding their late-stage pipelines.
  • These contributions have positioned our organization at the forefront of clinical innovation, with a sustainable and competitive development portfolio grounded in medical excellence and strategic execution.
  • A mid-sized leading Contract Research Organization (CRO).

Medical Director

IQVIA
12.2015 - 06.2023
  • Company Overview: Formerly QUINTILES, specializing in Allergy, Respiratory and Vaccine Division.
  • My role at IQVIA was to drive clinical trial success through comprehensive medical strategy and therapeutic area expertise in the design and execution of over 70 Phase I-IV clinical trials with a significant contribution to clinical development programs and new pipeline indications to support patient impact expansion.
  • In the dynamic and competitive world of clinical research, my ability to navigate complex medical strategies and design robust clinical trials was paramount to ensure that clinical trials were not only scientifically sound but also successful in real-world settings for the success of our partners therapeutic programs.
  • In my clinical development leadership roles, I have driven the advancement of key therapeutic programs targeting asthma, COPD, ILD and allergic diseases, resulting in multiple late-stage assets progressing to global regulatory submissions.
  • I led cross-functional teams in the design and execution of Phase II–IV clinical trials, optimizing protocols to enhance patient recruitment and improve data quality, which shortened development timelines by up to 25%.
  • My contributions included implementing patient-reported outcome measures, refining pediatric and adolescent study designs, and integrating real-world evidence into strategic planning.
  • These efforts not only supported expanded indications across diverse age groups but also played a critical role in delivering safe, effective, and accessible treatments for patients worldwide while significantly advancing therapeutic options in high-burden, immune-mediated diseases.
  • My accomplishment as a Medical Director with IQVIA was a proven track record of exercising strategic medical expertise during early engagement activities, BD opportunities as well as clinical trial design and execution.
  • This proactive approach led to the successful solidification of new partnerships with both small biotechnology and large pharmaceutical companies.
  • I was able to understand the unique needs and goals of each sponsor from being in previous roles as a direct care physician and Principal Investigator to ensure that every clinical trial was well-aligned with the broader objectives within the sponsor’s organization.
  • By leveraging my extensive therapeutic expertise in respiratory medicine and allergy, I was able to design clinical trials that are not only scientifically rigorous but also highly relevant in real-world settings.
  • This includes optimizing trial design to ensure that the outcomes are meaningful and applicable to the broader patient population and in line with the everchanging modern day landscape.
  • As one of the first board certified Allergy, Asthma and Immunologists; I had the opportunity to successfully grow IQVIA’s therapeutic area portfolios, particularly in Allergy, Pulmonology, and Atopic Dermatitis.
  • I was also the leading expert in monoclonal antibodies from my work in severe persistent asthma and atopic dermatitis.
  • This growth was driven by a deep understanding of both the changing medical landscape, competitive environment and the ability to identify emerging trends and opportunities to design successful clinical trials.
  • I was in a global medical leadership position, overseeing clinical trial teams and regional physicians in Europe, Asia-Pacific, and Japan.
  • Leading this cross-functional collaborative team ensured that clinical trials were conducted with the highest standards of medical excellence and regulatory compliance.
  • As the Global Medical Director, I played a pivotal role in coordinating these efforts, ensuring seamless collaboration across regions for medical excellence in clinical trial design and execution.
  • My responsibilities in medical affairs activities encompassed a wide range of critical functions, including late-phase clinical development, securing partnerships, and supporting regulatory submissions.
  • My medical expertise in protocol design, feasibility, and safety review ensured that every clinical trial was meticulously planned and executed.
  • As a Medical Director at IQVIA, I also was responsible for medical contributions to FDA and other regulatory authority submissions which was instrumental in advancing new therapies to market.
  • My work in leading clinical development programs in the therapeutic areas of cystic fibrosis, atopic dermatitis and asthma resulted in 4 BLA’s and 2 NDA’s.
  • A key aspect to the medical strategy was my commitment to pharmacovigilance and safety surveillance.
  • As the leader of the global medical team which consisted of a medical safety surveillance specialist, medical data reviewer and medical safety physician.
  • I developed comprehensive medical monitoring plans and conducted rigorous safety reviews to ensure the safety and efficacy of clinical trials.
  • This included the design and implementation of patient-centered solutions that prioritize both data-driven insights and the well-being of participants.
  • My experience as a Principal Investigator, Direct Care Physician, and Global Medical Monitor was instrumental in identifying and selecting optimal clinical trial sites.
  • This hands-on experience ensured successful site selection with the incorporation of medical expertise by focusing on evidence-based medicine and best practices in the relevant therapeutic areas, such as respiratory, allergy, immunology, atopic dermatitis and the inflammatory space.
  • By combining strategic medical insights with robust clinical trial design and execution, I was able to empower sponsors to bring new therapies to market more efficiently and effectively within their designated timelines.
  • Formerly QUINTILES, specializing in Allergy, Respiratory and Vaccine Division.

Urgent Care Physician

AFC Adult Urgent Care
02.2015 - 01.2016
  • Provided comprehensive care to both adult and pediatric patients with acute emergencies, ranging from wound care to pneumonia, ensuring prompt and accurate diagnoses and treatments.
  • Conducted phone triage to assess patient symptoms and determine the appropriate level of care, guiding patients to the most suitable treatment options.
  • Developed and implemented Electronic Medical Record (EMR) templates tailored for the urgent care setting, streamlining documentation processes and ensuring high standards of medical accuracy and compliance.
  • My ability to handle fast-paced environments and make quick, accurate diagnoses has improved patient outcomes and satisfaction.

Investigator/Medical Director

IMMUNOe RESEARCH AT GVR
10.2013 - 01.2015
  • Principal Investigator for respiratory, Immunology, atopic dermatitis and rare disease clinical research trials responsible for ensuring adherence to protocol and regulatory standards.
  • I initiated a new research site at our GVR location, where recruitment efforts exceeded the quota.
  • This achievement was driven by effective site management and strategic recruitment strategies within a practice location in an underserved area that brought patient’s hope.
  • I served as a Physician Investigator on over 30 research trials for various allergy, respiratory and inflammatory disease states, contributing to the development of new treatments and therapies.
  • I implemented an effective bridge between patient care clinics and research, ensuring seamless integration and enhanced patient engagement.
  • This collaboration facilitated the identification and recruitment of suitable participants for clinical trials allowing them access to potential cutting-edge therapies where there was an unmet need.
  • I developed and executed effective marketing and recruitment strategies for research trials, resulting in high patient enrollment rates and successful study completion.
  • I evaluated the feasibility of clinical trial protocols and provided comprehensive training to research personnel, ensuring that all team members were well-prepared and capable of executing the trials effectively.
  • I developed and maintained new Physician Investigator relationships, which significantly impacted study support and success.
  • I ensured immediate response to all Serious Adverse Events (SAEs) and Adverse Events (AEs), prioritizing patient safety at all times.

Physician

GVR ALLERGY & ASTHMA
10.2013 - 01.2015
  • As a Medical Director, I led a comprehensive medical practice and oversaw clinical operations, ensuring high-quality patient care and operational efficiency.
  • Provided direct care to adult and pediatric patients with immunological, respiratory, and allergic diseases, ensuring accurate diagnoses and effective treatments.
  • Conducted phone triage and telemedicine consultations for acute adult and pediatric disease states, offering timely medical advice and care.
  • Managed the Infusion Center for biologics, ensuring safe and efficient administration of treatments.
  • Launched a new Allergy & Immunology Practice at our GVR location, combining leadership, teamwork, and clinical skills with strategic thinking and planning.
  • Increased revenue at GVR by 70% while decreasing overhead, demonstrating strong financial management and operational excellence.
  • Increased the immunotherapy patient base by 80% and developed new safety guidelines to enhance patient safety.
  • Instituted new patient safety protocols to ensure the highest standards of care.
  • Continuously educated staff on clinical and scientific information through various oral presentations, fostering a knowledgeable and skilled team.

Shareholder Track Physician

ALLERGY PARTNERS
08.2012 - 10.2013
  • As a Medical Director, I led a successful Allergy, Asthma, and Immunology practice, focusing on patient care, business administration, and community engagement.
  • Developed a new patient base through strategic initiatives, exponentially increasing the practice's patient base significantly.
  • Managed phone triage and telemedicine for adult and pediatric patients, providing timely and effective medical care.
  • Cultivated new relationships with community physicians, generating referrals that accounted for 75% of the new patient base.
  • Supervised office staff, analyzed receipts, and instituted new protocols that effectively reduced overhead by 15%.
  • Engaged in various speaking engagements to educate local providers on allergic and respiratory disease states, enhancing community awareness and trust.

Pediatric Hospitalist

PEDIATRIX MEDICAL GROUP OF ROCKY MOUNTAIN HOSPITAL FOR CHILDREN
12.2010 - 07.2012
  • As an Inpatient Physician, I provided comprehensive urgent and emergent care to meet the medical needs of the pediatric and adolescent population.
  • Triaged and developed effective treatment plans for pediatric inpatients, ensuring timely and accurate care while building patient trust and rapport with families to enhance the supportive foundation for their medical care.
  • Exercised exceptional time management skills to handle multiple responsibilities, including admissions, discharges, consultations, direct patient care, patient and family education, and emergency management.
  • Collaborated with the healthcare team to carry out comprehensive treatment plans, ensuring coordinated and effective patient care from hospitalization to discharge.

Per Diem Physician

NATIONAL JEWISH HEALTH
07.2010 - 01.2012
  • Company Overview: America’s #1 Respiratory Hospital.
  • As a Triage Physician, I provided expert evaluation and treatment for walk-in adult and pediatric patients with a variety of conditions including severe persistent asthma, atopic dermatitis, COPD, ILD, food allergies, anaphylaxis, and allergic diseases.
  • Evaluated and treated walk-in adult and pediatric triage patients, addressing emergencies related to respiratory, inflammatory, and allergic diseases.
  • Conducted phone triage and telemedicine consultations for adult and pediatric patients with acute and chronic respiratory disease states, food allergies and atopic dermatitis exacerbations ensuring timely and effective medical care.
  • My experience at the National Jewish Medical and Research Center provided me with a unique opportunity to work in a leading respiratory hospital.
  • America’s #1 Respiratory Hospital.

Pediatric Attending

SCHNEIDER CHILDREN’S HOSPITAL URGICENTER
07.2007 - 06.2009
  • I supervised and educated first-year residents while simultaneously managing pediatric urgent care needs, including attending to fractures and managing asthma exacerbations.

Pediatric Hospitalist

NYACK HOSPITAL
07.2007 - 05.2009
  • My responsibilities included direct care on the inpatient ward, consultations, attending cesarean sections, and high-risk deliveries.
  • My expertise also extended to providing phone triage and telemedicine services, ensuring specialized care for pediatric patients, regardless of their location.

Education

Medical Doctorate -

ROSS UNIVERSITY MEDICAL SCHOOL
06.2003

Bachelor of Science - Cell Biology & Psychology

STATE UNIVERSITY OF NEW YORK @ NEW PALTZ
05.1997

Skills

  • Medical Leadership
  • Strategic Business Growth
  • Analyzing and Interpreting Scientific Data
  • Medical Monitoring Phase I-IV trials
  • Clinical Development
  • Protocol Design and Review
  • Early risk identification with proactive solutions
  • Innovative patient recruitment strategies
  • Construction of Patient Safety Protocols and SOP’s
  • Effective Communication and Organizational Skills
  • Critical and Strategic Thinking in Acute Emergencies
  • Excellent Interpersonal and Communication Skills
  • Successful execution and completion of Clinical Research Trials
  • Public Speaking
  • Medical strategy for successful trials and drug development
  • Effective Teaching Mechanisms in Patient Care
  • Presenting Scientific Studies at National Medical Conferences
  • Time and Project Management
  • Team player
  • Business Development and Administration
  • Cross-functional team leadership

Board Certifications

  • American Board of Pediatrics, 10/01/07
  • American Board of Allergy and Immunology, 10/01/11

State Medical Board Licenses

  • Colorado State Medical Board
  • California State Medical Board
  • Florida State Medical Board

Fellowship Training

Allergy & Immunology, NATIONAL JEWISH RESEARCH AND MEDICAL CENTER, 07/01/09, 06/01/11, Denver, Colorado

Residency Training

  • Pediatrics, SCHNEIDER CHILDREN’S HOSPITAL, 07/01/04, 06/01/07, New Hyde Park, New York
  • Obstetrics & Gynecology, MONMOUTH MEDICAL CENTER, 07/01/03, 06/01/04, Monmouth, New Jersey

Professional Memberships

  • AMERICAN MEDICAL ASSOCIATION, 07/01/04, Present
  • AMERICAN ACADEMY OF PEDIATRICS, 07/01/04, Present
  • AMERICAN ACADEMY OF ALLERGY, ASTHMA & IMMUNOLOGY, 07/01/09, Present
  • AMERICAN COLLEGE OF ALLERGY, ASTHMA & IMMUNOLOGY, 07/01/09, Present
  • WESTERN SOCIETY FOR ALLERGY, ASTHMA & IMMUNOLOGY, 11/01/14, Present
  • AMERICAN THORACIC SOCIETY, 11/01/14, Present

Clinical Trial Experience - Indications

  • Asthma
  • COPD
  • Interstitial Lung Disease
  • Cystic Fibrosis
  • Pulmonary Fibrosis
  • Alpha-1 antitrypsin deficiency
  • Pulmonary Hypertension
  • CRS
  • Rare Diseases
  • Allergy
  • Immunology/Autoimmune Diseases
  • Atopic Dermatitis
  • Psoriasis
  • Urticaria
  • Food Allergy
  • Mast Cell Diseases
  • Pediatrics

Timeline

Senior Medical Director

Fortrea
06.2023 - 10.2024

Medical Director

IQVIA
12.2015 - 06.2023

Urgent Care Physician

AFC Adult Urgent Care
02.2015 - 01.2016

Investigator/Medical Director

IMMUNOe RESEARCH AT GVR
10.2013 - 01.2015

Physician

GVR ALLERGY & ASTHMA
10.2013 - 01.2015

Shareholder Track Physician

ALLERGY PARTNERS
08.2012 - 10.2013

Pediatric Hospitalist

PEDIATRIX MEDICAL GROUP OF ROCKY MOUNTAIN HOSPITAL FOR CHILDREN
12.2010 - 07.2012

Per Diem Physician

NATIONAL JEWISH HEALTH
07.2010 - 01.2012

Pediatric Attending

SCHNEIDER CHILDREN’S HOSPITAL URGICENTER
07.2007 - 06.2009

Pediatric Hospitalist

NYACK HOSPITAL
07.2007 - 05.2009

Bachelor of Science - Cell Biology & Psychology

STATE UNIVERSITY OF NEW YORK @ NEW PALTZ

Medical Doctorate -

ROSS UNIVERSITY MEDICAL SCHOOL

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