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Roches Clinical Development organization is structured by therapeutic area and is responsible for developing and executing the late development clinical strategies and plans that deliver medically differentiated therapies that provide meaningful improvement to patients.
Roche is looking for an experienced and highly specialized individual to join the Cardiovascular Renal and Metabolism group. The role of the Lead or Senior Medical Director will focus on guiding and shaping our cardiovascular outcomes strategy. To be successful in this role you will need to have extensive experience in late stage drug development and managing large-scale clinical trials including outcome studies in particular we are looking for candidates with experience in heart failure programs.
You will have strong collaboration with cross-functional teams including clinical research regulatory affairs and medical affairs to ensure the successful progression of treatments through the pipeline and into the market. The position would also require a strong understanding of cardiovascular diseases clinical trial protocols regulatory requirements and possibly interactions with regulatory agencies to ensure studies meet the required standards.
You will interact with high level management and experts both internally and externally serving as internal consultants
You are expected to provide critical insights and contributions to the development and effectiveness of the assigned project
You have demonstrated a high level of experience in Clinical Development Plan (CDP) Strategy & Planning Execution Regulatory Activities and Cross-Functional Team work/matrix leadership.
You willmentor other physicians / scientists in their disease area of expertise as required.
You have an MD (board certified in Cardiology is preferred); along with significant clinical trial/late stage development experience in CVRM studies. Minimum 5 years of pharma/biotech R&D experience
You have experience authoring global trial plans and working with various health authorities as well as an understanding of how to run a large CV outcome trial. You have championed novel/innovative approaches to clinical development (i.e. study design endpoints technology)
You have a strong external network with relevant experts for CVOTs.
You have regulatory experience: providing clinical science information and input for regulatory submissions and other regulatory process
You have the ability to collaborate with a variety of internal and external partners and stakeholders such as clinical investigators clinicians scientists and key opinion leaders (KOLs) as well as multidisciplinary internal groups including other groups in PD research business development commercial operations legal etc resulting in demonstrable outcomes
You have strong interpersonal skills: outstanding interpersonal verbal and written communication and influencing skills: have built and cultivated important relationships both inside and outside of Roche; have proven abilities to influence internal partners and stakeholders thought leaders national advocacy organizations national standard-setting bodies and other relevant external parties
If you are a Cardiologist with experience in Heart Failure Clinical Programs we would love to hear from you.
A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.
Lets build a healthier future together.
Roche is an Equal Opportunity Employer.
Required Experience:
Director
F. Hoffmann-La Roche AG is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange. The company headquarters are located in Basel.