1104Health

Medical Advisor

Galderma

Collaborating with medical experts in safety/medical listings review and queries elaboration in EDC, developing medical presentations on studies interim analysis, maintaining competitive intelligence landscape, reviewing and updating medical monitoring guidance document, contributing to inspection readiness, managing periodic benefit-risk evaluation reports (PBRER's).

Senior Clinical Scientist

Leading RBQM strategy for the whole nemolizumab program, managing the IT solution platform vendor and the CRO's, reviewing and approving studies specifications documents, conducting risk review meetings with the study teams, examining data trends (such as range, consistency, variability) within and across sites, discussing studies central monitoring issues (root cause analysis, mitigation, corrective and preventive actions), providing input to clinical monitoring and processes improvements.

Risk-Based Quality Management (RBQM) Coordinator 

Developing protocols and study design for nemolizumab, a first-in-class monoclonal antibody directed against the IL-31 receptor alpha (IL-31 is involved in pruritus of different conditions such as Atopic Dermatitis, Prurigo Nodularis and patients with Chronic Kidney Disease) as well as protocol amendments, clinical study reports (CSR’s), informed consent forms (ICF’s) and other study documents; Owning scientific rationale of the protocol; Maintaining current and future competitive clinical landscape; Coordinating with team members to address scientific questions related to planned or ongoing clinical trials; Contributing to the preparation of regulatory documentation and answering to questions from Health Authorities during the review process; Preparing and reviewing SOP’s and contributing to process improvement initiatives; Organizing Scientific Advisory Boards and KOL reviews; Participating in Independent Data Monitoring Committee (IDMC) and Independent Adjudication Committee (IAC) meetings; Collaborating with medical experts in safety reviews.

ICON plc

Leading the Clinical Operations team for the clinical research program for COVID-19 anti-spike monoclonal antibodies casirivimab and imdevimab, managing/coaching the team with their deliverables, performing quality review of MVR’s and providing feedback for the team, reviewing team performance metrics and handling 1:1 meetings, leading site escalation calls, driving audit responses through corrective/preventive actions (CAPA’s), overview of enrollment trends, discussing recruitment and retention strategies, monitoring sites performance by reviewing available reports (like Safety Information System compliance, missing visits compliance...), providing insights to improve processes overall.

Senior Clinical Study Lead

IQVIA

Leading medical initiatives for rare diseases (Gaucher disease), direct leadership of medical science liaisons (MSLs) team, KOLs engagement, participation in the process of technology transfer from a biotech to the Brazilian government, development of a phase IV study protocol to assess bone disease in Gaucher patients, providing strategic inputs to marketing, sales force training.

Medical Affairs Lead - Associate Director

Pfizer

Leading medical affairs initiatives of Pfizer Consumer Healthcare products, including over-the-counter - OTC products (Advil, Caltrate, Stresstabs, Clusivol and Magnesia) and food supplements (Centrum, Imedeen, Omega-3, phytosterols, lutein and other antioxidants). Elaboration of medical strategy, claims creation/substantiation, promotional materials review, sales force training, medical detailing, healthcare professionals and medical societies relationship, scientific data dissemination, management of medical advisor, medical assessment of products development and innovation, partnership with regulatory team in BoH submissions.

Senior Medical Manager

Responsible for providing clinical expertise by ensuring the clinical study report provides an accurate representation of the study conduct, results, and conclusions. Evaluation of labs and other safety data, determination of the significance of protocol deviations. Selecting, hiring and managing a CRO team.  Training them for ICH, GCP, regulations, SOPs… Center visits with the team, cleaning databases backlog, preparation for audits, periodically reporting studies status to the global team.

Bioequivalence Studies Clinician

Supporting marketing activities in the established products business unit.
The established products division comprises the following therapeutic areas:
- Central Nervous System: Efexor (venlafaxine), Zoloft (sertraline), Lorax (lorazepam), Frontal (alprazolam) and its presentations regular, extended release and sublingual.
- Women's Health: Dostinex (cabergoline), Premarin (equine conjugated estrogens) oral and vaginal cream, Totelle (estradiol and trimegestone), Harmonet, Minesse and Minulet (oral contraceptives which combines gestodene and ethinylestradiol), DepoProvera (medroxyprogesterone acetate), Nordette (levonorgestrel and ethinylestradiol), Cartrax (tioconazole and tinidazole), Trofodermin (clostebol + neomicina).
- Men's Health: Viagra (sildenafil), Carduran (doxazosine), Detrusitol (tolterodine).
- Cardiovascular: Citalor (atorvastatin), Norvasc (amlodipine), Aldactone (spironolactone).
- Pain, inflammation and antiinfectives: Feldene (piroxicam), Cicloxx (meloxicam), Motrin (ibuprofen), Ponstan (mefenamic acid), Tramal (tramadol), Zitromax (azithromycin).

Product Medical Manager of Established Products

Bayer Health Care

Monitoring of serious adverse events and causality evaluation of single-case processing (mainly clinical trials reports but also published, spontaneous and patient support programs reports), data retrieval for analysis of similar events for SUSAR cases, mentoring of newcomers, sharing medical knowledge, products/diseases training (biological and developing drugs).

Drug Safety Specialist

Roche

Medical knowledge coordination of monoclonal antibodies and tyrosine-kinase inhibitors: Avastin - bevacizumab (colon cancer), Herceptin - trastuzumab (breast cancer), MabThera - rituximab (lymphoma), Tarceva - erlotinib (lung and pancreas cancers), Xeloda - capecitabine (colon and breast cancers), supporting marketing activities (constant acting with product managers) and pharmacoeconomics team, training sales force and joining representatives at the front line, coordination of two clinical trials, developing of key opinion leaders (KOLs), organizing meetings, participating in congresses.

Medical Manager

Previwork

Attending employees from different companies (Roche, Novartis, TIM, Saint-Gobain, Avon, Firmenich, Rotary Club), preventing and treating diseases.

Occupational Health Physician

Prefeitura Municipal de São Paulo

Physician at basic units attending the population and preventing diseases through individual consultations, home visits and group lecturres.

General Health Care Practitioner

FAPESP

Development of a scientific project during medical school supported by FAPESP

Publication: 
Respir Physiol Neurobiol. 2009 Jan 1;165(1):13-21.
Oral tolerance attenuates airway inflammation and remodeling in a model of chronic pulmonary allergic inflammation.

Research Scientist

Physician with 18 years of professional experience (14 years in the pharma industry/CRO’s)
Clinical Development, Medical Monitoring, Drug Safety and People Development experience
Experience in different therapeutic areas (including Immunology, Oncology, Dermatology and Rare Diseases)

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