Suzanne Mela, MD

• Senior Global Medical Director for Phase I-IV respiratory and immunology clinical trials for adults and pediatrics across NA, EU, and APAC, delivering 100% on-time FPI, LPI, and database lock milestones with over 95% protocol adherence.
• Directed cross-functional teams of 50+ across medical, development, regulatory, and data management in a global matrix environment.
• Provided critical medical input to the FDA and regulatory authorities, including IND and BLA submissions.
• Key medical expert in five clinical development strategies, with a particular emphasis on late-stage clinical programs.ms.
• Developed 15 protocols with strategically aligned endpoints and milestone metrics to support FDA/EMA submissions.
• Partnered with two biotechnology companies, driving a 35% portfolio expansion, and enabling three new programs to enter Phase III.
• Conceptualized and launched the Ambassador Program, cultivating 150+ new PI/KOL relationships, enhancing targeted site selection, and therapeutic program development.
• Expanded trial site network by 40%and reduced startup timelines by20% through the Ambassador Program's personalized site engagement approachDeveloped 15+ medical monitoring plans, supporting 8,000+ safety reviews, and enabling real-time risk mitigation using digital dashboards.
• Designed and implemented an AI-driven pharmacovigilance tool, improving adverse event signal detection by 30% and reducing SAE reporting lag by 25%.
• Developed a risk review platform and mitigations for 10+ trials, reducing trial delays by 30%, and supporting over $3 million in cost avoidance.
• Led strategic site selection across 120+ global sites, accelerating site activation timelines by 25%.
• Developed IB's, safety review plans, ICF's, pharmacy manuals, Medical Monitoring Plans, CSR's and engaged in medical data reviews.
• Reduced subject dropout rates by 30% through digital engagement and mobile retention strategies across five global studies.
• Delivered 12+ presentations at global investigator meetings and scientific congresses, enhancing trial and pipeline visibility, and stakeholder collaboration.

Clinical Development and Regulatory Submissions.

• Led 20+ clinical development programs across asthma, COPD, ILD, PH, atopic dermatitis, CRS with NP, and rare diseases, driving 3 Biologics License Applications (BLAs), and 2 New Drug Applications (NDAs) to FDA approval.
• Key medical expert for regulatory submissions, including IND, BLA, and NDA filings, ensuring alignment of clinical data with FDA/EMA requirements
• Spearheaded late-stage trial designs for biologics in atopic dermatitis and asthma, resulting in four label expansions.

Medical Monitoring and Trial Execution

• Lead 70+ Phase I-IV trials as Global Medical Monitor, with responsibilities spanning:
• Protocol design, ICF development, eCRF medical input, and eligibility criteria optimization.
• Implementation of AI-driven pharmacovigilance tools to reduce adverse event reporting delays by 25%, and improve safety signal detection.
• Training of PIs and internal teams on protocol-specific requirements, reducing protocol deviations by 30% in high-enrollment trials.
• Developed risk-based monitoring strategies and site selection criteria, achieving 95% site activation efficiency and 20% faster enrollment in global respiratory trials.
• Designed and executed patient-centric recruitment campaigns, leveraging KOL networks and digital tools to reduce dropout rates by 30% in AD and rare disease trials.

Business Development and Pipeline Expansion.

• Expanded therapeutic portfolio by partnering with 15+ biotech sponsors and 5 global pharmaceutical companies, securing $50M+ in contracted clinical development revenue.
• Led end-to-end strategies for assets from proof of concept to Phase III, accelerating timelines by 6–12 months through data-driven decision-making and cross-functional execution.
• Established strategic collaborations with KOLs and academic institutions.

Innovation & Leadership

• Mentored 10+ junior medical monitors, fostering a culture of scientific rigor and regulatory compliance across global teams.

• Principal Investigator for respiratory, Immunology, atopic dermatitis and rare disease clinical research trials.
• Initiated a new research site at our GVR location, where recruitment efforts exceeded the quota.
• Served as a Physician Investigator on over 30 research trials for various allergy, respiratory and inflammatory disease states.
• Implemented an effective bridge between patient care clinics and research.

• Led a comprehensive medical practice and oversaw clinical operations.
• Provided direct care to adult and pediatric patients with immunological, respiratory, and allergic diseases.
• Managed the Infusion Center for biologics, ensuring safe and efficient administration of treatments.

• Led a successful Allergy, Asthma, and Immunology practice.
• Developed a new patient base through strategic initiatives.
• Cultivated new relationships with community physicians.

• Company Overview: America’s #1 Respiratory Hospital.
• Provided expert evaluation and treatment for walk-in adult and pediatric patients.
• Conducted phone triage and telemedicine consultations.
• America’s #1 Respiratory Hospital.