|Job Posting This is a visible, critical and high profile role within Covance in the Clinical Trial Strategy and Design Group. This individual will design and lead the therapy area strategy globally and needs to be of a high caliber, impressive internally and an ambassador to external clients. This new hire will be a true thought leader in Cardiovascular, Diabetes and Metabolic diseases and will bolster the impressiveness of the disease area within Covance. They will lead the strategy globally and the Project Management group will implement it.
This person will position ideas working very closely with a team of senior writers and data analysts to bring about evidence based strategy. This person will be a strong influencer to inspire and motivate the team working with very senior leaders with advanced presentation skills. This individual will also work closely with senior level clients to develop cutting edge and innovative plans, with the ability to think on their feet and connect with customers. In this truly global and highly strategic role we are looking for a thought leader with therapy area depth and experience thinking about how best to develop drugs on a global basis including Asia, Latin America, US, Europe etc
¦ Provide executive level, global leadership in the development and implementation of the CDS (Clinical Development Services) P3 (Predictive Feasibility and Informatics Modeling; Proactive Project Planning and Prevention of Errors) model
¦ Position operationalizes P3 by working with Business Development and Operations, through the design of evidence-based study plans, study engineering and study governance.
¦ Position works at the executive level to effectively integrate and promote service offerings across OS&P (Organizational Strategy & Planning) and promotes these services to internal and external customers.
¦ Ensure that OS&P staff is able to provide an evidence-based approach, to the design of innovative, but practical and fiscally responsible strategies for inclusion in relevant business development documents and for use in the successful implementation and conduct of clinical trial programs for clients.
¦ Network with others throughout Covance and an external customer base to ensure OS&P provides relevant input to project strategies and associated planning activities
¦ Ensure the engagement of OS&P with project teams at key time points in the project lifecycle to ensure actual performance is in line with strategic plan and provides advanced interventional guidance when required.
¦ Remain current with industry innovations and advances so as to include relevant advances and technology into the design of trial strategies.
¦ Line management responsibility for the recruitment, training, utilization, development and performance review of assigned personnel
¦ Fiscal responsibilities for the global OS&P Group
Covance is committed to diversity in the workplace and is an equal opportunity employer. (M/F/D/V). Your confidentiality and privacy are important to us.
• Educated to PhD level plus a University/College Degree
• Thorough understanding of global drug development and the clinical trial project management process
• Thorough and practical working knowledge of ICH-GCP Guidelines, including relevant international requirements/guidelines for the conduct of global clinical development programs
• An understanding of aspects surrounding business development (time and cost estimates, bid defense, contracts)
• An extensive technical background in Cardiovascular / Metabolic studies (especially Diabetes)
• Very strong technical writing skills and analytical skills
• Strong networking abilities and an ability/willingness to work with individuals across the globe
• Excellent communication, planning & organizational skills
• Ability to inspire, to lead by example and motivate global teams to seek solutions and get results
• Strong abilities to negotiate and liaise with customers in a professional manner
• Thorough experience in end to end (full service) clinical trial management, including global project management experience
• Abilities to review/analyze relevant data so as to build evidence-based strategies
• Abilities to design/develop effective strategies to bring about trial success, as defined by clients and project teams through the use of an evidence-based approach.
• Minimum of twelve years relevant clinical research experience in a pharmaceutical company/CRO, including at least five years of full project management responsibility.
• Strong computer skills with an ability to understand and access and leverage technology alternatives.
• Ability to work independently
• Demonstrated ability to handle multiple competing priorities effectively.
EEO Employer Covance is committed to diversity in the workplace and is an equal opportunity employer. (M/F/D/V). Your confidentiality and privacy are important to us.
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