Director of Central Regulatory

## Director of Central RegulatoryApplyremote type: Fully Remotelocations: USA, TN, Nashvilletime type: Full timeposted on: Posted Yesterdayjob requisition id: JR0147615**It’s More Than a Career, It’s a Mission.**Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives of patients diagnosed with cancer every day.**Our Mission**People who live with cancer – those who work to prevent it, fight it, and survive it – are at the heart of every decision we make. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical excellence and cutting-edge research, SCRI is redefining cancer care around the world.As the **Director of Central Regulatory**, you are responsible for the end-to-end leadership, oversight, and performance of regulatory operations, ensuring the delivery of high-quality, compliant, and timely regulatory outcomes across the portfolio. This role provides both strategic direction and hands-on operational leadership, driving execution through clear governance, risk management, and accountability frameworks.You will partner closely with cross-functional Site Support Operations teams and the broader Site Management Organization, as well as site research teams and investigators, to evaluate, align, and optimize ongoing regulatory processes. You will ensure cross-functional coordination to enable efficient, scalable, and inspection-ready execution that meets or exceeds organizational, regulatory, and sponsor expectations.You must demonstrate strong leadership, strategic thinking, and operational discipline, with the ability to balance high-level direction and detail-oriented execution in a complex, fast-paced environment. This role requires excellent communication, influence, and customer service skills to effectively engage and partner with internal stakeholders and external partners, including sponsors, CROs, IRBs, investigators, and physicians.* Establish and maintain regulatory compliance and quality standards, ensuring inspection readiness for audits, inspections, and sponsor oversight* Oversee CAPA, non-compliance investigations, and issue resolution, ensuring timely, accurate, and defensible outcomes* Proactively identify, assess, and mitigate regulatory and operational risks, with clear escalation to leadership as needed* Ensure adherence to GCP, IRB requirements, internal SOPs, and regulatory guidelines, including development and continuous improvement of SOPs and working practices* Ensure timely, accurate, and inspection-ready regulatory submissions, approvals, and maintenance activities across the full study lifecycle* Provide oversight and direction for study startup and ongoing regulatory maintenance activities, ensuring alignment with timelines and sponsor expectations* Maintain visibility to portfolio-level performance, priorities, and execution risks, and take action to mitigate delays* Serve as a key escalation point to resolve complex operational and regulatory issues across sites and studies* Create and sustain a decision-driven operating model, with clear ownership, escalation pathways, and traceability across all levels of the organization* Establish and track departmental goals, KPIs, and performance metrics, ensuring alignment with organizational objectives* Provide regular, transparent communication to executive leadership on risks, progress, and performance* Ensure issues are escalated appropriately and resolved within defined timelines* Partner closely with Site Support Operations, study teams, and Site Management Organization stakeholders to drive aligned, efficient regulatory processes* Collaborate with sites, investigators, sponsors, CROs, and IRBs to ensure quality delivery and strong working relationships* Engage with site leadership to ensure contracted regulatory services are delivered effectively and consistently* Represent the organization’s regulatory strategy, standards, and expectations to internal and external stakeholders* Lead, develop, and optimize the regulatory organization by driving performance accountability, aligning resources to priority work and risk areas, and building leadership capability and bench strength* Foster a collaborative, high-performance culture focused on ownership, quality, and continuous improvement* Develop and implement strategies to support recruitment, retention, and professional development* Evaluate and optimize regulatory processes to improve efficiency, standardization, and scalability* Lead or support process improvement and transformation initiatives, including automation and system enhancements* Identify and eliminate process inefficiencies and workflow gaps impacting delivery* Contribute to development and execution of organizational and departmental strategies* Provide proactive, data-driven recommendations to improve performance and mitigate risk* Align regulatory operations with broader clinical, operational, and business objectives* Provide high-level customer service and issue resolution to internal and external stakeholders* Ensure clear communication of performance expectations, priorities, and status updatesYou should have for this position:* Comprehensive knowledge of GCP, FDA regulations, IRB requirements, and sponsor expectations* In-depth understanding of clinical trial lifecycle and regulatory processes (startup, maintenance, closeout)* Knowledge of regulatory compliance frameworks, CAPA processes, and audit/inspection readiness standards* Familiarity with organizational SOPs, systems, and operational workflows supporting regulatory activities* Understanding of performance metrics, KPIs, and risk indicators used to manage regulatory operations* Knowledge of process improvement methodologies, transformation initiatives, and system optimization strategies* At least five years of research experience within research sites or industry* At least five years of management experience with direct reports* At least five years of experience working within a research startup team* Research certification (ACRP or CCRP) preferred* Bachelor Degree required**About Sarah Cannon Research Institute**Sarah Cannon Research Institute (SCRI) is one of the world’s leading oncology research organizations conducting community-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. In 2022, SCRI formed a joint venture with former US Oncology Research to expand clinical trial access across the country. It has conducted more than 850 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA in the past decade. SCRI’s research network brings together more than 1,300 physicians who are enrolling patients into clinical trials at more than 200 locations in 20+ states across the U.S. Please click here to learn more about our research offerings. We care about the well-being of the patients and communities we serve, and that starts with caring for our people. That’s why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse colleague population and ensure they are the healthiest versions of themselves. For more information regarding benefits through our parent company, McKesson, please click here. As part of Total Rewards, we are proud to offer a competitive compensation package. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.McKesson has become aware of online recruiting-related scams in which individuals who are not affiliated with or authorized by McKesson are using McKesson’s (or affiliated entities, like CoverMyMeds or RxCrossroads) name in fraudulent emails, job postings or social media messages. In light of these scams, please bear the following in mind: McKesson Talent Advisors will never solicit money or credit card information in connection with a McKesson job application.McKesson Talent Advisors do not communicate with candidates via online chatrooms or using email accounts such as Gmail or Hotmail. Note that McKesson does rely on a virtual assistant (Gia) for certain recruiting-related communications with candidates.McKesson job postings are posted on our career site: careers.mckesson.com.*We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.* #J-18808-Ljbffr