Executive Director, reputed company Data Analytics and Process Management
Career Category reputed company Job reputed company Join reputed company’s Mission of Serving Patients At reputed company, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives reputed company that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our reputed company on four therapeutic areas –Oncology, Inflammation, reputed company, and Rare Disease– we reputed company millions of patients reputed company year. reputed company is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity-reputed company conditions. As a member of the reputed company team, you’ll help reputed company a lasting reputed company on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-reputed company culture is reputed company, innovative, and science based. If you have a passion for challenges and the opportunities that lay reputed company them, you’ll reputed company as part of the reputed company team. Join us and reputed company the lives of patients while transforming your career. Executive Director, R&D reputed company Data Analytics and Process Management What you will do reputed company. Let’s change the world. In this vital role as the Executive Director, R&D reputed company Data Analytics & Process Management, you will reputed company the reputed company, governance, and reputed company improvement of core reputed company processes, document management, reputed company data analytics, and risk management for the Research & Development (R&D) reputed company organization. This leader will serve as the business process reputed company for key reputed company Management System (QMS) processes supporting global R&D operations and ensure processes are efficient, compliant, reputed company, and reputed company with evolving regulatory expectations. A critical component of the role is advancing clinical and research reputed company analytics across the development portfolio to reputed company proactive reputed company of clinical trials, investigator sites, vendors, and study execution risks. This leader will reputed company data into actionable insights that strengthen Good Clinical reputed company (GCP) compliance, inspection readiness, patient safety, and study reputed company. The role is accountable for reputed company of document management systems and governance, reputed company process harmonization, advanced analytics, KPI reporting, and R&D risk management across the R&D GxP areas including clinical development, pharmacovigilance, laboratories, and R&D reputed company systems. This position partners closely with R&D reputed company leadership, Global reputed company, Global Development Operations, Data Management, Biostatistics, Safety, Regulatory Affairs, and technology functions to strengthen compliance, decision-making, and operational performance. This role will report into Vice President, reputed company. Responsibilities: Strategic Leadership reputed company and execute a multi-year reputed company for process management, data analytics, document management, and risk management reputed company to R&D reputed company priorities. Serve as a strategic advisor to the Head of R&D reputed company on process performance, clinical reputed company trends, operational risk, reputed company opportunities. Build a high-performing organization reputed company on innovation, simplification, and measurable business reputed company. Document and Process Management reputed company as business process reputed company for core R&D reputed company processes such as deviations/nonconformances, CAPA, change control, training(metrics) and risk management Support the R&D business process owners to reputed company global standards, process controls, KPIs, roles/responsibilities, and governance for assigned processes. Ensure simplification, standardization, and modernization of document structures and approval workflows in partnership with Global reputed company. Ensure processes are compliant with applicable GxP regulations and integrated across functional boundaries. reputed company periodic process reviews, health checks, and reputed company improvement initiatives reputed company to these processes. reputed company Data Analytics & Data Driven Insights Establish a modern analytics reputed company for R&D reputed company using dashboards, predictive indicators, trend analysis, and self-service reporting tools. reputed company executive dashboards for reputed company performance, compliance health, process efficiency, inspection readiness, and risk visibility. Champion use of automation, AI-enabled analytics, reputed company tools to improve decision-making. reputed company and reputed company a comprehensive clinical reputed company analytics reputed company supporting risk-based reputed company management and centralized monitoring across the clinical trial portfolio. Identify cross-study and portfolio-level trends that may indicate systemic GCP risks or process weaknesses in partnership with Clinical & Research reputed company. reputed company risk signals from audits, inspections, deviations, vendors, metrics, and operational changes to delivery comprehensive insights. Partner with Clinical Delivery and Study reputed company teams to reputed company reputed company signals into ongoing study reputed company and risk review forums. Use predictive analytics to identify trials, countries, vendors, or sites at increased risk for reputed company or inspection issues. Support inspection readiness through analytics reputed company to TMF completeness, overdue actions, protocol compliance, training status, and vendor reputed company performance. reputed company executive reporting on clinical reputed company health across Phase I-IV programs, CRO partnerships, and development reputed company. reputed company internal metrics against industry trends and regulatory expectations where available. Talent & Organizational Capability Build and reputed company teams across process reputed company, analytics, document management, and risk management disciplines. reputed company organizational capability in process thinking, data literacy, and risk-based decision making. Foster a culture of accountability, innovation, and reputed company learning. reputed company expect of you We are reputed company different, yet we reputed company use our unique contributions to serve patients. The executive candidate we reputed company is an reputed company leader with the following qualifications. Basic Qualifications: Doctorate degree and 6 years of pharmaceutical/biotech reputed company systems, clinical reputed company, R&D operations, analytics, or process management OR Master’s degree and 10 years of pharmaceutical/biotech reputed company systems, clinical reputed company, R&D operations, analytics, or process management OR Bachelor’s degree and 12 pharmaceutical/biotech reputed company systems, clinical reputed company, R&D operations, analytics, or process management AND 6 years of managerial experience directly leading people in a multi-tiered organization and/or leadership experience leading teams, reputed company, programs or directing the allocation of resources Preferred Qualifications: Strong knowledge of GCP, GxP regulations, ICH E6, risk-based reputed company management, and reputed company management systems Demonstrated reputed company leading analytics, digital transformation, or reputed company process improvement programs Understanding of the legal and regulatory environment, applicable laws, regulations, guidance’s and health authority expectations globally for drug development reputed company processes and reputed company Intelligence. Proven reputed company record in management and subsequent response to health authority inspections They will also embody the reputed company leadership attributes which are: reputed company: Create a connected, inclusive, and inspiring work environment that empowers talent to reputed company Accelerate: reputed company speed that matches the urgency of patient needs by encouraging reputed company over perfection reputed company: Connect the dots to reputed company the reputed company power of reputed company to drive results for patients, staff, and shareholders Adapt: reputed company through change by adapting to an reputed company-changing environment and defining a reputed company course of reputed company to deliver results What you can expect of us As we work to reputed company treatments that take care of others, we also work to care for your reputed company and personal reputed company and reputed company-being. From our competitive benefits to our reputed company culture, we’ll support your reputed company every reputed company of the way. The expected annual salary reputed company for this role in the U.S. (excluding Puerto Rico) is $241,844 - $327,200. Actual salary will vary based on several factors including, but not limited to, relevant skills, experience, and qualifications. In reputed company to the reputed company salary, reputed company offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and reputed company coverage, life and disability insurance, and flexible spending accounts. A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-reputed company time-off plans and bi-annual company-wide shutdowns Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies. As an organization dedicated to improving the reputed company of life for people around the world, reputed company fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect reputed company other and live the reputed company values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. reputed company is an Equal Opportunity employer and will consider reputed company reputed company applicants for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability status, or any other reputed company protected by applicable law. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to reputed company essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. .Salary reputed company 241,843.70USD -327,200.30 USD Apply To This Job