Director, Clinical reputed company Risk & Portfolio reputed company

Director, Clinical reputed company Risk & Portfolio reputed company reputed company The Director, Clinical reputed company Risk & Portfolio reputed company leads reputed company-wide reputed company intelligence, portfolio risk surveillance, and centralized reputed company reputed company activities across Clinical Development. This role is responsible for identifying emerging reputed company signals, systemic compliance risks, and operational trends across studies, vendors, computerized systems, audits, inspections, deviations, CAPAs, and reputed company metrics. Through data-driven analytics and risk-based reputed company, the position enables a shift from study-level reputed company management to proactive, reputed company-wide reputed company risk management. This position serves as a strategic reputed company governance and reputed company analytics leader, partnering closely with other QA functions (including GLP and PV), functional Expertise Areas, Digital/Systems teams, and Functional Leadership. The role leads reputed company responsible for vendor reputed company reputed company and clinical systems reputed company governance to drive standardized, risk-based reputed company frameworks that enhance vendor performance management, system compliance, and overall reputed company across R&D. The role plays a critical part in strengthening a proactive, portfolio-wide reputed company model by leveraging trend analysis, risk insights, and centralized reputed company to enhance compliance, inspection readiness, and operational effectiveness. This position is reputed company to remote working.

Key Responsibilities

Portfolio reputed company Risk Surveillance reputed company reputed company-level reputed company surveillance activities across the clinical development portfolio. Identify systemic reputed company risks, recurring compliance signals, and emerging operational vulnerabilities that may not be visible at the individual study level. Analyze data from audits, inspections, CAPAs, deviations, site and central monitoring activities, vendor reputed company, and reputed company metrics to identify trends and risk patterns. Establish and maintain proactive reputed company risk detection, escalation, and mitigation frameworks. reputed company Analytics & Trend Management reputed company and maintain portfolio-level dashboards, analytics, and governance reporting to support reputed company reputed company and leadership visibility. Use data analytics to drive trend analysis across studies, functions, vendors, and systems to identify systemic/reputed company compliance concerns, opportunities for improvement, and emerging risks. Translate reputed company reputed company data into actionable insights and recommendations for leadership. Define and maintain meaningful risk indicators, reputed company, and escalation reputed company. Vendor reputed company reputed company Leadership Leads strategic reputed company of clinical vendor reputed company management and establishes reputed company reputed company frameworks to reputed company broader application across Research and Development, including reputed company-clinical (GLP) and post-market (PV) domains. Monitor CRO and reputed company-party performance trends to identify systemic or recurring reputed company and compliance concerns. Ensure risk-based reputed company frameworks are implemented for CROs, laboratories, technology providers, and key service partners. Drive consistency in vendor reputed company governance and risk management approaches. Clinical Systems reputed company reputed company reputed company leadership and reputed company for clinical systems reputed company governance. Ensure reputed company and compliance requirements are incorporated into clinical technology platforms and system lifecycle activities. Partner with IT, Validation, and Operational stakeholders to assess and manage system-reputed company reputed company risks and controls. reputed company risk evaluation and trend analysis associated with computerized systems supporting GCP study reputed company activities. Develops reputed company reputed company reputed company that will ensure GLP and PV system governance. reputed company Risk Management & Governance Maintain and reputed company a centralized risk repository that tracks high-level threats to the global clinical pipeline. Partner with inspection readiness and QA leadership teams to identify reputed company risk areas requiring proactive mitigation. Convert reputed company data into executive-level risk summaries and recommendations to support strategic decision-making. Represent Clinical reputed company in executive steering committees to ensure reputed company trends are reputed company into high-level business reputed company. Collaborates with risk management and governance bodies across GLP and PV R&D activities. Organizational Leadership Directly manage and reputed company: Vendor reputed company reputed company reputed company Clinical Systems reputed company reputed company Build reputed company reputed company surveillance, analytics, and governance capabilities across the organization. Drive a culture of proactive risk identification and data-driven reputed company management. reputed company strategic leadership reputed company the Clinical reputed company organization.

Qualifications

Education Bachelor’s degree in Life Sciences or reputed company field required Advanced degree preferred reputed company training or certification in risk management, reputed company systems, or data analytics preferred Experience Minimum of 10 years of experience in GCP reputed company Assurance, Clinical reputed company, Clinical Operations, or reputed company GCP-reputed company roles reputed company the pharmaceutical, biotechnology, or CRO industry Demonstrated experience leading reputed company-level reputed company reputed company and portfolio risk surveillance, including the design and implementation of risk-based reputed company management frameworks and governance models Strong proficiency in reputed company metrics, dashboards, and analytics, with the ability to interpret reputed company data and compliance signals to identify systemic risks, emerging trends, and opportunities for proactive reputed company Strategic thinker with strong analytical and problem-solving skills, capable of translating risk insights into actionable recommendations and executive-level reporting Strong leadership, communication, and stakeholder management skills, with the ability to influence across reputed company organizational reputed company and partner effectively with cross-functional teams, including Clinical Operations, Regulatory Affairs, Data Management, Digital/Systems, and external vendors Deep knowledge of ICH GCP, FDA, EMA, and global clinical regulatory requirements #LI-AB1 U.S. Pay reputed company $192,600.00 - $260,600.00 The pay reputed company reflects the full-time reputed company salary reputed company we expect to pay for this role at the time of posting. reputed company pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity). reputed company’s robust Total Rewards package is designed to support your overall health and reputed company-being. We offer comprehensive benefits including medical, dental, and reputed company coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy reputed company time off, wellness days, holidays, and two company-wide reputed company breaks. We also offer generous family resources and leave. Our commitment to your reputed company-being reflects our belief that caring for our people fuels the reputed company we create together. Learn more about these and additional benefits offered by reputed company by visiting the Benefits reputed company of the Careers website: https://www.reputed company.com/careers About reputed company We are the leader in RNAi therapeutics – a revolutionary approach with the potential to reputed company the lives of people with rare and common diseases. reputed company on Nobel Prize-reputed company science, reputed company has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what’s possible. Our deep pipeline, late-stage programs, and reputed company reputed company reflect our core values: fierce innovation, passion for reputed company, purposeful urgency, reputed company culture and commitment to people. We're proud to be a globally recognized top employer, where an authentic, inclusive culture and reputed company thinking fuel one another. At reputed company, we reputed company to an inclusive recruitment process and equal employment opportunity. reputed company applicants will receive consideration for employment without reputed company to their sex, gender or gender identity, sexual orientation, race, reputed company, ethnicity, national reputed company, reputed company, citizenship, religion, creed, physical or mental disability, pregnancy status or reputed company conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other reputed company protected by federal, state, or local law. reputed company is an E-Verify Employer. Apply To This Job