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Job #02977

About our client Our client is a publicly traded pharmaceutical company headquartered in Michigan with over 10 years of success in the development and commercialization of Nephrology and Urology therapeutics. The company has an experienced management team, a robust pipeline and an empowering corporate culture that is focused on the professional development of its employees. Position Location Chief Medical Officer Michigan Salary Highly competitive package, commensurate with experience Responsibilities 1) Direct and lead the Clinical Development Plan for successful completion of Phase III study 2) Lead and direct development of Phase III clinical trial protocol 3) Direct and lead submission of NDA/PMA for approval 4) Lead and direct regulatory approval process including interfacing with FDA medical reviewers to address clinical trial issues, study results and agency concerns 5) Lead and direct clinical application procedures and practices in conjunction with study investigators 6) Develop a global clinical development and regulatory approval plan 7) Lead and direct Development Team in selecting consultants, project personnel, scientific staff and other resources (as required) 8) Interface with nephrology/hematology community to provide technical expertise at conferences, professional organizations and academic liaison 9) Lead and direct SFP Scientific Advisory Board including setting SAB agenda, SAB recruitment and leading SAB meetings 10) Be the SFP technical spokesperson for interfacing with Wall Street analysts, institutional investors and dialysis providers 11) Review and coordinate dissemination as well as publication of study results 12) Collaborate with senior management on drug development strategy 13) Lead and direct process to evaluate potential drug development candidates 14) Develop clinical development plans for other drugs and devices (as directed) 15) Prepare a clinical development plan for vitamin/carnitine drug license 16) Develop a regulatory approval plan for product line extensions 17) Function as Chief Scientific Officer and the Lead In-house Technical Expert on nephrology and hematology issues 18) Ensure development plans complies with ICH guidelines 19) Lead CMS interface for pre-approval reimbursement efforts and dialogue 20) Evaluate, recommend and recruit post-approval scientific and regulatory organization to support post-approval marketing 21) Lead post-approval letter and private insurance industry interface Requirements 1) BA in a scientific discipline and MD 2) Experience in nephrology and/or hematology 3) Experience as a Principal Investigator on clinical trials and as a Physician Executive 4) Expertise in protocol designing and approval 5) Experience in FDA medical reviewer interfacing 6) Understanding of current literature on hematology, ESA and anemia 7) Expertise in anemia management issues 8) Demonstrated project-management expertise 9) Excellent presentation and problem-solving skills 10) Experience in all drug development processes and bringing a drug through FDA approval 11) Proven track record in the nephrology/hematology community with good network of contacts 12) Strong communication and interpersonal skills to interface with analysts, academics, doctors, customers and staff 13) Ability to be a strong advocate and interface with provider community 14) Ability to evaluate other potential drug candidates and lead the drug development process 15) Highly energetic and enthusiastic individual with a collaborative mindset