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.
