Managing Director / Head of CRO job vacancy in Upsilon Global (United States)

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Company name : Upsilon Global
Location : United States
Position : Managing Director / Head of CRO

Description :
Head of CRO – Homebased, USA – Expanding CRO Specialising in Oncology/Cardiology
Upsilon Global have been selected as the exclusive recruitment partner to an exciting and highly reputable small/mid-sized CRO as they further expand their operations across North America. Initially establishing a presence in America in 2020, our partner has grown the US team to 30 operational staff across clinical operations, regulatory and medical affairs, securing numerous service agreements with a number of exciting biopharmaceutical sponsors.
Given the success of their American expansion, our partner are now hiring a Head of CRO to design, implement and drive operational strategy globally, working to ensure successful execution of complex clinical trials across the therapeutic portfolio as well as further developing their CRO capabilities. You’ll work closely with the CEO and oversee a teams across The US, Europe and APAC.
This is a fantastic opportunity for anyone with a proven track-record in the cross-functional delivery of global clinical trials to have a real, tangible impact on the operational running of a growing CRO, utilising past experiences to create a high-performing, high quality service provider.

Background
Initially an SMO, our CRO partner evolved to provide a full service CRO offering, utilising their expert site networks to provide an efficient and high quality CRO service. Established 20 years ago, they have a solid foundation and impeccable reputation within oncology and cardiology, as well as solid roots in urology and pulmonology
Responsibilities

Overall responsibility and accountability for ensuring successful and efficient execution of complex global clinical trials across therapeutic portfolio
Build CRO business capability within the organization, drive implementation and maintenance of internal clinical research systems and processes including clinical operations and biometrics, project governance, project finance and clinical and biometrics IT systems
Hiring, management and development of the clinical research team and assignment of resources to the project teams in line with project budget requirements
Accountable for ensuring project profitability, financial efficiency, client service deliverables and client satisfaction
Ensure adherence by the Clinical Operations team and Investigators to specific study protocols, and compliance with established clinical research standards (ICH & GCP) governing the conduct of clinical studies
Identify program risks, and together with relevant stakeholders, implement mitigation strategies
Establishment and management of relationships with key vendors, service providers and external business partners
Support the assessment and development of new business opportunities
Active contribute to business development through marketing of CRO services, lead generation and procurement of new trial opportunities
Partner with Business Units, SRO/site research teams, Quality Assurance, Corporate & Business Development teams to ensure consistent and excellent service delivery in line with CRO Business Strategy
Collaborate effectively with Business Development from other internal business units on potential opportunities
Lead/partner the development of new models of operations to align with partnership objectives and goals
Establish and maintain clinical study metrics to support the continuous improvement in performance, delivery and quality of clinical research and demonstrate the cost, time and efficiency gains as a result of these improvements. Bring industry experience and best practice to deliver continuous improvement

Background/experience

Lifescience degree within scientific field
Extensive professional experience (10-15 years) in clinical research, preferably working within CROs, however Pharmaceutical and/or Biotechnology also considered
At least 7+ years’ experience in US based CRO and understanding of US regulatory environment
Proven track record of having successfully led global clinical trials, with experience across all functional capabilities involved in CRO-directed clinical research (project management, medical & scientific affairs, safety/pharmacovigilance, quality assurance, data management, site-related activities etc)
Proven experience in all aspects of clinical trial management, including implementation of organizational systems and processes for CRO management of clinical trials (eg clinical operations, finance, quality assurance, governance systems/SOPs/structures)
Deep understanding and comprehensive practical knowledge of ICH-GCP requirements, including across different jurisdictions
Experience working in Oncology therapeutic areas highly preferable
Able to work in an international environment with internal & external team partners (including virtual teams) and Asia Pacific/European experience is highly desirable
Business Development and financial knowledge and capability highly desirable

About you

A self-motivated leader who demonstrates high energy and empathy, is able to influence demonstrates savviness to interpersonal skills across all levels of the business
Ability to think strategically and tactically about R&D for internal and external programs
Demonstrates ability to handle and oversee multiple tasks simultaneously and to prioritize in a meaningful way
Excellent tactical, execution and organizational abilities
Can build quality relationships with all levels of management and cross-functional teams, driving a collaborative and long-term partnership environment
Experience leading matrix and/or project-based teams
Undertake travel, domestically and internationally to fulfil the requirements of the role

To apply, please follow the link or contact Upsilon Global directly.

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