Senior Director , Clinical Trial Strategy and Design – CVMER
The Senior Director, Clinical Trial Strategy and Design uses an evidence-based approach to design innovative and pragmatic, fiscally responsible strategies for use in the successful implementation and conduct of phase IIa-IV interventional clinical trial programs within our CVMER (cardiovascular, metabolic, endocrine, renal) group. You will lead new business opportunities while designing large phase 3 registration trials, writing proposals and preparing presentations for bid defenses which outline the strategy and plans for trial conduct. Once implemented, you will engage with project teams to ensure actual performance is in-line with the strategic plan and provide guidance as needed.
The ideal candidate must have a proven scientific track record (preferably PhD) with a strong understanding of at least one core area in the CVMER therapeutic area. You must be skilled in data analysis, interpretation, utilization, and testing. This role requires strong presentation skills and a positive personal presence. We are seeking a skilled leader with experience in scientific investigation strategy.
This position can be home-based anywhere in the US. Up to 30% travel required on occasion.
Covance, the drug development business of Laboratory Corporation of America Holdings (LabCorp), is the world's most comprehensive drug development company, dedicated to advancing healthcare and delivering Solutions Made Real® by providing high-quality nonclinical, clinical and commercialization services to pharmaceutical and biotechnology companies to help reduce the time and costs associated with drug development. Because of our broad experience and specialized expertise, we're in a unique position to supply insights that go above and beyond testing — We have helped pharmaceutical and biotech companies develop each of the top 50 prescription drugs in the marketplace today. We also offer laboratory testing services to the chemical, agrochemical and food industries and are a market leader in toxicology services, central laboratory services, discovery services, and a top global provider of Phase III clinical trial management services.
The Cardiovascular, Metabolic, Endocrine and Renal (CVMER) therapeutic group is highly unique in its sheer scope and size-with focus areas ranging from extremely rare indications to prevalent disease states. From heart disease to diabetes, and obesity to non-alcoholic fatty liver disease, the experts at Covance are working toward the discovery of the most advanced therapies using stem cells and regenerative medicine, lipid modification, cardiovascular devices, and so much more.
Requirements:
-phd in a science-related field is highly preferred
-thorough understanding of global drug development process and clinical trial project management process
-thorough and practical working knowledge of ich-gcp guidelines, including relevant international requirements and guidelines for the conduct of global clinical development programs experience -5+ years' experience in clinical trial planning and design
-expert in at least one of the following: cardiovascular, endocrinology, metabolism, or renal clinical trials eeo employer covance is committed to diversity in the workplace and is an equal opportunity employer (minority/female/individual with disability/veteran/sexual orientation/gender identity). your confidentiality and privacy are important to us.
