Ricardo Rocha, MD
EVP and Global Head of Medical Affairs @ Madrigal Pharmaceuticals
About
- Seasoned leader with 25 years of pharmaceutical experience leading clinical development and medical affairs programs with successful launches in multiple therapeutic areas (CV, NS, Rare Diseases) - Proven track record building, transforming and leading clinical development and medical affairs organizations with successful execution of major launches in multiple therapeutic areas in the US and Globally
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United States
Pharmaceuticals
Clinical Development, Medical Affairs, Hypertension, Clinical Trials, Pharmaceutical Industry, Drug Development, Therapeutic Areas, Translational Medicine, Medical Writing, Cardiology, Metabolism, Clinical Research, Medicine, Oncology, Diabetes, ICH-GCP, CRO, Pharmacovigilance, GCP, CTMS
Experience

EVP and Global Head of Medical Affairs
Leads the Global Medical Affairs organization responsible for advancing scientific exchange, generating impactful RWE and supporting the broad Madrigal’s pipeline in close collaboration with Commercial and Clinical Development across our key markets.

Head of Medical Affairs
Cambridge, Massachusetts, United States
Leads overall Medical Affairs strategic vision, operations and long-range planning across the Intellia Tx platform. Member of Development Leadership Team. Responsible for creating a near term and long term global medical affairs organization, along with department policies and practices. Developing organizational structure to maintain company's resource optimization, prepare the Intellia organization for multiple simultaneous launches and adapt overall company to an evolving healthcare environment. Actively engaged in Development programs and other Intellia strategic initiatives, including building a Medical Affairs infrastructure fully integrated with Commercial and Clinical development to support execution of phase I-III clinical trials.

Regional Medical Head, Latin America and Canada
East Hanover, New Jersey
Leads overall Medical organization (~300 associates), including strategic vision, operations and long-range planning across the Region. Member of LaCan Pharma Executive Committee. Oversees Regional office Medical team as well as six Chief Scientific Officers. Partners with line function heads (Access, Commercial, Business innovation, etc.) on execution of company business strategy and engagement of external stakeholders in preparation for multiple simultaneous launches (Kesimpta, Inclisiran, Zolgensma, etc.) across diverse healthcare systems in the Region.

Vice President and Head, Cardiorenal and Metabolism Medical Unit
East Hanover, New Jersey
Leads cardiovascular CD&MA US program and builds cardio-renal and metabolism pipeline including 1 in-line (Entresto) and four development compounds (serelaxin, canakinumab, TQJ230 and LNP023). US medical lead in BD&L activities. Oversees team of >100 associates. Notable accomplishments: - Established industry-leading HF research and education program including successful completion of major clinical studies (PIONEER-HF - https://www.nejm.org/doi/full/10.1056/NEJMoa1812851), HF registry and best-in-industry multichannel education program. - Pioneered major implementation/dissemination research collaborations - Built leading culture in Novartis Pharma, reflected in internal cross divisional LWS surveys, medical execution metrics and external blinded surveys (ZS)

Head, US Clinical Development & Medical Affairs (a.i.)
East Hanover, New Jersey
Leads overall US CD&MA strategic vision, operations and long-range planning across five therapeutic areas. Member of US Pharma Executive Committee. Directs six Vice Presidents/Medical Unit Heads, and four line function heads (HEOR/Medical Access, Clinical operations, Regulatory, Medical information/Field Medical) with oversight of ~500 associates. Continually enhances and redefines organizational structure to maintain company's resource optimization, prepare Medical organization for multiple simultaneous launches and helps adapts overall company to an evolving healthcare environment. Actively engages in Global Drug Development and Global Pharma strategic planning sessions. Notable Accomplishments: - Successfully drove 2020 medical planning/annual budget cycle, including strategic planning for four launches (Siponimod, Ofatumumab, Brolucizumab and Fevipiprant) through rigorous prioritization. - Recognized by US/Global leadership for outstanding culture and team contributions during a.i. role.

Disease Area Head, Heart Failure
Novartis
East Hanover
Leads HF clinical development and medical affairs program for Novartis HF portfolio in the US • Responsible for development and implementation of strategic plan for HF brands, including Entresto and Serelaxin • Partners with commercial team developing and implementing brand strategies and launch readiness plans for HF brands • Manages HF clinical trial program including 3 outcomes trials, >15 clinical trials and real world evidence studies • Partners with Global Development on preparation of regulatory strategy for serelaxin • People management: 10 direct reports

Executive Medical Director - US Medical Head, LCZ696
East Hanover, NJ
Leads development and implementation of US medical strategic vision and plan for LCZ696 • Design and execution of medical product plan • Develops highly differentiating, clinical/scientific platforms supporting medical communications for LCZ696 • Partners with key line functions to develop and present strategic vision, medical assessments, plans and recommendations to US Senior Leadership Teams at key Decision Points • Supports commercial team developing and implementing brand strategies and launch readiness plans for LCZ696, leading to strongly aligned medical and commercial plans • Leads internal/external medical communications around key milestones (PARADIGM HF outcomes trial results disclosure) and other major events • Leads medical team on design and execution of Phase IIIb/IV trials • Partners with Global Development on preparation of NDA for LCZ696 and execution of registrations trials in the US

Global Brand Medical Director, Hypertension - Global Medical Affairs
Basel Area, Switzerland
• Major contributions developing and implementing global strategic vision and plans for multiple hypertension and heart failure brands (Diovan, Exforge, Rasilez, Serelaxin, LCZ696) • Design and execution of integrated strategic product plans as core member of Global Product Teams • Develops highly differentiating, clinical/scientific platforms supporting commercial positioning and market access strategy for new and in-line products resulting in industry leading launches (Exforge) • Partners with key line functions to develop and present strategic vision, medical/commercial assessments, plans and recommendations to Senior Leadership Teams at key Decision Points • Synergizes with commercial team developing and implementing brand strategies and launch readiness plans for new and in-line brands globally, leading to strongly aligned medical and commercial plans • Extensive experience in Japan, China and Emerging Growth Markets • Leads internal/external medical communications around key milestones (RELAX-AHF, NAVIGATOR, ALTITUDE, ASTRONAUT, ACCOMPLISH, VALUE outcomes trial results disclosure) and other major events (ALTITUDE early termination) • Robust crisis management experience including Senior Executive level updates and interactions • People management: 1-4 direct reports - direct responsibility for an extended team of 8-12 associates

Global Brand Medical Director, Serelaxin - Global Medical Affairs (a.i.)
Novartis
Basel Area, Switzerland
• Planning and implementation of a global medical affairs programs for Serelaxin following completion of RELAX-AHF trial • Design and execution of integrated product strategic plan for serelaxin as core member of the Global Product Team • Managed medical communications for RELAX AHF, including internal and external communications around primary results presentation at AHA in Nov 2012 and training of Novartis Medical associates world-wide

Global Program Medical Director - Global Clinical Development
Novartis
East Hanover, NJ
- Global Development lead for Diovan/Exforge - Led team that successfully delivered one NDA submission in Switzerland (Diovan) and one type 2 variation submission in Europe (Exforge) - Successfully managed regulatory interactions with EMA to align on pediatric program for Diovan which ultimately led to a pediatric indication - Managed multifunctional development team with 5 direct reports and indirect responsibility for an extended team of 20+ associates

Disease Area Head, Hypertension
East Hanover, NJ
• Promoted from Associate Medical Director to Disease Area Head with increasing levels of responsibility for building the hypertension portfolio medical strategy for the USA • Successful execution of 20+ hypertension and heart failure clinical trials (including 5 mega-trials) from 2003-2010 • Built scientific platform supporting Diovan growth to blockbuster status and successful development and launch of Exforge, Exforge HCT and multiple aliskiren brands in the US • Established data-mining program for Diovan in 2004 that generated key new data with global impact • People management: 5-7 direct reports - direct responsibility for an extended team of 30+ associates
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