Associate Director, Clinical Site Startup and Engagement Process Excellence

2 weeks ago


Greenfield, United States Takeda Full time

Description Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as an Associate Director, Clinical Site Startup and Engagement Process Excellence & Delivery based remotely reporting to the Head, Clinical Site Startup and Engagement Process Excellence and Delivery.At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.Here, you will be a necessary contributor to our inspiring, bold mission.This position is responsible for helping to further the strategic advancement of Clinical Site Startup &Engagement (CSSE) through innovation and excellence. Primary responsibilities include but are not limited to: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.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 or 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. Takeda Compensation and Benefits SummaryWe understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.For Location:Massachusetts - VirtualU.S. Base Salary Range:$153,600.00 - $241,340.00The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO StatementLocationsMassachusetts - VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeJob ExemptYesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.



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