Associate Director, Clinical Site Startup and Engagement Process Excellence & De
Scorpion Therapeutics, New Bremen, Ohio, United States
Role Summary
Associate Director, Clinical Site Startup and Engagement Process Excellence & Delivery. This role is remote, reporting to the Head, Clinical Site Startup and Engagement Process Excellence and Delivery. Massachusetts - Virtual location. Responsibilities
Works directly with the Head of Process Excellence & Delivery to develop and execute CSSE strategic plans, projects, and commitments to drive operational efficiencies and connectivity across CSSE, Global Development Office (GDO) and Research & Development (R&D). Assist with building new capabilities for the CSSE organization by becoming a Subject Matter Expert (SME) developing new and/or updating defined standard operating practices (SOPs), guidance documents/job aids, tools, and templates to accelerate transformation towards predictive and agile ways of working. Work with partners and cross-functional colleagues on an enhanced operating model to ensure consistent delivery of global clinical trials by streamlining processes, enhancing systems, and creating effective tools/templates. Support the implementation of process optimization by aligning with business practices set forth by management and continuous improvement initiatives/workstreams becoming a change agent within CSSE, integrating process, and implementing training plans. Drive best-in-class process agility and efficiency, by harnessing innovation to automate data collection and documentation, enhancing compliance, improving quality and robustness of CSSE process. Ensure implementation of new/updated processes and technologies are in compliance with quality standards (including ICH, GCP, local regulations and Takeda SOPs). Ensure that crucial strategic and operational cross-organizational issues/projects/initiatives are addressed efficiently and track progress of initiatives, working with teams and leaders across R&D functions. Qualifications
Bachelor’s Degree or international equivalent required; Life Sciences preferred. Advanced degree is highly desirable. 7 or more years’ experience in the pharmaceutical industry and/or clinical research organization, with demonstrable deep understanding of clinical trial development and delivery process. 7 or more years of direct operational experience in pharmaceutical drug development with direct exposure to clinical development (i.e., study management, study startup, country and site feasibility) in a highly matrix organization across multiple regions. Knowledge of FDA and ICH-GCP guidelines for conducting clinical research. Global/international experience required, including ability to collaborate with colleagues and staff in other locations. Experience in people leadership, managing global teams, change management and coordinating collaboration with cross-functional teams. Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables. Strong strategic thinking, planning, execution, and communication skills. Health care business acumen with a comprehensive understanding of the pharmaceutical industry. Education
Bachelor’s Degree or international equivalent required; Life Sciences preferred. Advanced degree is highly desirable. Skills
Strategic thinking and planning Execution and delivery of complex programs Communication and stakeholder management Change management and process transformation Global collaboration and cross-functional leadership Knowledge of clinical trial development, ICH-GCP, and regulatory standards
#J-18808-Ljbffr
Associate Director, Clinical Site Startup and Engagement Process Excellence & Delivery. This role is remote, reporting to the Head, Clinical Site Startup and Engagement Process Excellence and Delivery. Massachusetts - Virtual location. Responsibilities
Works directly with the Head of Process Excellence & Delivery to develop and execute CSSE strategic plans, projects, and commitments to drive operational efficiencies and connectivity across CSSE, Global Development Office (GDO) and Research & Development (R&D). Assist with building new capabilities for the CSSE organization by becoming a Subject Matter Expert (SME) developing new and/or updating defined standard operating practices (SOPs), guidance documents/job aids, tools, and templates to accelerate transformation towards predictive and agile ways of working. Work with partners and cross-functional colleagues on an enhanced operating model to ensure consistent delivery of global clinical trials by streamlining processes, enhancing systems, and creating effective tools/templates. Support the implementation of process optimization by aligning with business practices set forth by management and continuous improvement initiatives/workstreams becoming a change agent within CSSE, integrating process, and implementing training plans. Drive best-in-class process agility and efficiency, by harnessing innovation to automate data collection and documentation, enhancing compliance, improving quality and robustness of CSSE process. Ensure implementation of new/updated processes and technologies are in compliance with quality standards (including ICH, GCP, local regulations and Takeda SOPs). Ensure that crucial strategic and operational cross-organizational issues/projects/initiatives are addressed efficiently and track progress of initiatives, working with teams and leaders across R&D functions. Qualifications
Bachelor’s Degree or international equivalent required; Life Sciences preferred. Advanced degree is highly desirable. 7 or more years’ experience in the pharmaceutical industry and/or clinical research organization, with demonstrable deep understanding of clinical trial development and delivery process. 7 or more years of direct operational experience in pharmaceutical drug development with direct exposure to clinical development (i.e., study management, study startup, country and site feasibility) in a highly matrix organization across multiple regions. Knowledge of FDA and ICH-GCP guidelines for conducting clinical research. Global/international experience required, including ability to collaborate with colleagues and staff in other locations. Experience in people leadership, managing global teams, change management and coordinating collaboration with cross-functional teams. Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables. Strong strategic thinking, planning, execution, and communication skills. Health care business acumen with a comprehensive understanding of the pharmaceutical industry. Education
Bachelor’s Degree or international equivalent required; Life Sciences preferred. Advanced degree is highly desirable. Skills
Strategic thinking and planning Execution and delivery of complex programs Communication and stakeholder management Change management and process transformation Global collaboration and cross-functional leadership Knowledge of clinical trial development, ICH-GCP, and regulatory standards
#J-18808-Ljbffr