Medical & Scientific Affairs | Idea & Thought Leadership Strategy
Dynamic VP-level medical leader offering vision and expertise to add value to hospitals, pharmacies, surgical centers, physicians’ offices, clinics, and long-term care facilities. Improve safety and effectiveness of medical management and serve as proponent of innovation and market development to deliver on strategic goals. Launch new products in global markets. Serve as a key business partner, providing strategic guidance to deliver robust and positive change. Analyze efficiency of people and processes and travel globally to engage with regulatory bodies, multilateral government agencies, and key opinion leader (KOL). Serve as team champion, promoting accountability, nurturing collaboration, and supporting transparency and communication. Strengths include ability to motivate staff and drive positive change despite ambiguous situations. Fluent in Portuguese, Italian, Spanish, and French.
Lead geo-expansion efforts in support of new launches from initial product development through phase II, III and IV for Baxter-sponsored and investigator initiated trials. Foster and manage relationships with regulatory authorities and global societies in which Baxter has dealings. Maintain medical and business perspective to engage with commercial organization; foster strong, collaborative partnerships. Strengthen development of product value proposition. Highlighted Responsibilities: • Oversee global medical affairs activities for integrated pharmacy solutions franchise, including parenteral nutrition, monobags, 2CB’s, 3CB’s, pharmacy automation, compounding automation and solutions, vitamins, trace elements, generics and elastomeric devices; develop and coordinate industry-sponsored trials. • Coordinate investigator initiated trials, lead publication management, evidence generation management, and development of published evidence reviews to support marketing strategies. • Manage new product development, registration and portfolio geo-expansion; develop e-learning and training platforms to assist with internal and external training, KOL management, and relationships with international societies. • Build relationships with advisory boards; provide medical support of marketing activities, lifecycle management, global market access, global HEOR, and interactions with regulatory bodies (internal regulatory audits, quality audits, FCA’s, pre-submission meetings with regulatory authorities, medical support for regulatory submissions and product registration). • Draft global value dossiers for existing and new products, conduct competitive intelligence assessments, and deliver medical support to market development. Highlighted Achievements: • Designed and coordinated mandatory industry sponsored studies for registration of new products in United States, China, India, Western Europe, Australia/New Zealand, Mexico, Turkey, and Brazil. o New Product launches included: Clinokeic / Clinolipid; Oliclinomel; Olimel; Clinomel; Suprane; Healthports; Plasmalyte, and Finomel. • Drove successful launch of several new products in international markets. Provided global medical affairs support and defined global marketing plans. o Demonstrated knowledge of regulatory landscape and registration for new products, which included participating in registration and promoting successful launches; o Registered Numeta first-in-class ready to use commercially prepared IV nutrition product available for preterm newborns in 13 countries in Western Europe, Colombia, Turkey, and South Korea. • Authored content and condensed literature in meaningful way for marketing; translated content into clinical messaging and product claim repositories used as backbone for Baxter’s marketing materials. • Created and launched standing advisory boards to support organization development, which included securing support for creation of new technologies and delivery opportunities. • Developed alternative delivery systems for fluids and nutrition leading to pioneering use of subcutaneous tissue for nutrition and first global submission for registration of product to reduce complications and healthcare-associated infections. • Coordinated successful merger & acquisition (M&A) effort of of Baxa, and joint venture of Laboratoires Aguettant (France) and JW holdings (South Korea) leading to launch of new products and successful integration of medical affairs strategies.
Maintained accountability for medical affairs across APAC; coordinated team of 60 from various geographic regions. Oversaw hospital products and integrated pharmacy solutions for all 4 franchises, including fluid systems, pumps, elastomerics, nutrition, pharmacy automation, drug delivery, integrated closed systems, anesthesia and critical care, compounding automation, and biosurgery. Coordinated and interfaced with Asia Pacific Economic Cooperation (APEC), which included members from 21 Pacific Rim member economies. Engaged with Ministry of Health regarding importance of healthcare and burdens to healthcare system resulting from infections. Highlighted Achievements: • Added value at speaker-related events to sustain products, support Asia-Pacific portfolio geo-expansion, new product launches, and registration, including engagement with TGA and CFDA, key region regulatory bodies. • Coordinated multi-center industry-sponsored and investigator initiated clinical studies. • Interfaced with multilateral government agencies, including APEC in development of new policies and regulations for APEC economies. o Developed training, supported market access and HEOR groups, generated evidence to sustain and launch new products, and led implementation of FCA’s and product recalls; provided medical affairs support for audits and inspections. • Coordinated emergency response actions related to Baxter products across Asia-Pacific; provided medical affairs support to create business projects, including first public-private partnership (PPP) in Singapore to develop automated compounding facility to provide IV drugs for country. • Delivered medical affairs support for development of new automatic nursing platforms for Chinese market and designed HEOR study to support project. • Designed benchmark simulation training for inhaled anesthesia for Asia-Pacific region.
CHRISTUS UNIVERSITY SCHOOL OF MEDICINE, Fortaleza, Brazil
2010
to 2013
Served as professor of intensive care and emergency medicine in one of Brazil’s most prestigious medical universities. Taught graduate and post-graduate medical students and residents supporting development of several scholarly works in basic and applied medical sciences. Leveraged problem-based learning platforms, simulation training, and traditional learning platforms to facilitate learning and inspire students to engage in compelling discourse.
Led activities of 3 ICU’s for adults and neonatal patients for 2 accredited ISO hospitals. Led multidisciplinary team of 60+ staff across both locations, including physicians, surgeons, nurses, respiratory therapists, social workers, dietitians and pharmacists. Coordinated phase III and IV clinical studies as president of Dr. João Pompeu Lopes Randal Studies and Research Centers, work incorporated into international clinical guidelines, including ASPEN / SCCM guidelines for nutrition in critically ill patients. Coordinated OPAS and Joint Commission accreditation for hospital. President, hospital ethics committee; president, transplant committee; member, infection control committee. Interacted with International Nosocomial Infection Control Consortium. Head, medical residence in critical care medicine.
Led efforts of 5 ICU’s for adults, cardiologic, post-surgical, pediatric and neonatal patients; directed multidisciplinary team of 130+ healthcare professionals, including physicians, surgeons, nurses, respiratory therapists, social workers, dietitians and pharmacists. Coordinated phase III and IV clinical studies. Head, medical residency in internal medicine. Managed accreditation with OPAS, ISO 9000, ISO 9002 and Joint Commission. President, hospital ethics committee.
Served in consulting capacity for Latin America hospital products franchise, which included assisting in launch of numerous products in Mexico, Colombia, Argentina, Chile, and Brazil. Developed training and marketing materials; assisted with KOL management and development of KOL mapping and speaker databases. Managed relationships with local and international societies. Worked with Baxter Global HEOR, which led to creation of global models to evaluate impact of closed IV systems to reduce bloodstream infection rates. Pursued by Baxter for full-time role in recognition of business and medical affairs contributions.
Advised regarding launch of several products across Europe, USA, Latin America, and APAC as international consultant for Ross Products division. Developed internal and external training, managed KOL’s and mapped KOL’s to speaker databases.
Assisted with launch of Xigris. Developed training, marketing materials, and KOL management. Managed relationships with national critical care societies, including AMIB and surviving sepsis campaign.
