Associate Director, Clinical Site Management and Monitoring Oversight
Madrigalpharma, Phila, Pennsylvania, United States
Associate Director, Clinical Site Management and Monitoring Oversight page is loaded## Associate Director, Clinical Site Management and Monitoring Oversightlocations:
PA - Pennsylvania – Remotetime type:
Full timeposted on:
Posted Todayjob requisition id:
JR\_000563Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH. Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c). Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To support our continued growth, we are strengthening our workforce strategy to ensure we have the right talent, at the right time, in the right way.Job DescriptionThis role will partner with the Sr Director to develop the Clinical Monitoring Oversight program, and to build and manage an internal US CRA (Monitoring) field force. The Associate Director partners with CROs and cross-functional teams to drive monitoring performance and operational excellence at the CRA and site levels by performing targeted and risk-based oversight activities and collaborating with the cross-functional trial team to manage and resolve issues. The Associate Director engages Madrigal sites and networks to develop relationships and support optimal site performance within Madrigal trials. The Associate Director will also manage an internal CRA field team within their region of the US.**Key Responsibilities:****Monitoring Oversight**o Partner with the Sr Director of CRA Field Force to develop and implement the Madrigal Monitoring Oversight program to ensure sponsor oversight of outsourced trialso Utilizing a risk-based approach, perform remote and on-site Monitoring Oversight Visits within a regional US territoryo Document and communicate visit findings to CRO partners and Madrigal stakeholders; assess trends across studies and sites; and manage mitigations, resolutions and CAPAs to remediate identified issues as neededo Provide sponsor support to CRAs and sites at Site Qualification Visits, Site Initiation Visits, and Monitoring Visitso Develop and foster relationships with Madrigal sites within a regional US territory to drive compliance and support optimal performanceo Serve as a Madrigal escalation resource and partner with the CRO, trial team and/or sites to resolve compliance, data and/or monitoring issues**CRA Field Force Team Development and Management**o Partner with the Sr Director of CRA Field Force to develop and implement the internal Madrigal Monitoring programo Build and manage a group of high-performing Madrigal CRAs within a regional US territory (West, Central or East) that monitor Madrigal trialso Contribute to the creation of controlled documents (SOPs, Work Instructions, Job Aids, Templates, Forms) pertaining to Monitoring, and customize for insourced trialso Partner with the Sr Director of CRA Field Force to develop interview, onboarding, andcontinuous education training materials for Madrigal CRAso Strategically allocate internal CRA resources to studies and siteso Review and approve Madrigal CRA Monitoring Visit schedules, reports and expenseso Perform Monitoring Oversight Visits to assess and manage internal CRA performanceo Support internal CRAs and engage with sites at Site Qualification Visits and Site Initiation Visitso Partner with the Sr Director of CRA Field Force and cross-functional stakeholders to develop internal site and monitoring analytics and dashboards to assess site health and monitoring performanceo Customize trial Clinical Site Monitoring Plan for studies monitored by Madrigalo Collaborate with cross-functional stakeholders at Madrigal to ensure trial milestones and goals are met; represent the CRA Field Force team at trial team meetings to share metrics, trends and issues pertaining to sites and monitoringo Conduct site network, site and KOL engagement activities on behalf of Madrigal within a regional US territory**Experience and Professional Qualifications:**o The applicant should be a dynamic leader who thrives within a fast-paced, growing, and collaborative, publicly owned biopharmaceutical companyo Proven track record of successfully managing CRAs across various phases and therapeutic areaso Experience with developing training programs, systems and tools for CRAso Demonstrated ability to influence peers within a matrixed and fast-paced organizationo Strong strategic thinking, problem-solving, and influencing skillso Recent experience with Veeva Vault systems (TMF, CTMS)**Critical Competencies for Success:**o Strong interpersonal capabilities; demonstrates an ability to build and maintain positive site and CRA relationshipso Strong verbal communication and technical writing skillso Fluent in English languageo Ability to present concepts clearly utilizing scientific and regulatory terminologyo Sound organizational skills that support the ability to work independently and efficientlyo Proactive approach to identifying challenges and solutionso Detail-oriented nature paired with critical reasoning skills to identify and resolve issues**Required & Desired Qualifications**· Bachelor’s degree in life sciences, nursing, pharmacy, or related field; advanced degree a plus· 10+ years of clinical operations or monitoring experience, with a minimum of 2+ years in a field CRA role, and additional 2+ years in a prior CRA Manager or Monitoring Oversight (of outsourced monitoring) role· Ability to travel 50%, on averageMadrigal’s Total Rewards strategy is based on a biotech industry peer group comparator and is inclusive of base pay, bonus and equity. Our equity offers meaningful opportunity allowing our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization.All employees receive equity, which we believe reinforces our ownership culture. Base salary is determined by several factors including the candidate’s qualifications, skills, education, experience, business needs and market demands.
As of the date of this posting, a good faith estimate of the current pay scale for this position, applicable to all candidates, is $172,000 - $211,000 per year.
We comply with all applicable minimum wage laws.All full-time employees receive equity, which reinforces our ownership culture and offers meaningful opportunity for our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization.
Full-time employees are also eligible for comprehensive benefits, including flexible paid time off, medical, dental, vision and life/disability insurance, and 401(k) offerings (i.e., traditional, Roth, and employer match) in accordance with applicable plans. We also offer additional voluntary benefits like supplemental life insurance, legal services, and other offerings. In addition, we offer mental health benefits through our Employee Assistance Program for employees and their family. The company also provides other benefits in accordance with applicable federal, state, and local laws.
We #J-18808-Ljbffr
PA - Pennsylvania – Remotetime type:
Full timeposted on:
Posted Todayjob requisition id:
JR\_000563Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH. Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c). Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To support our continued growth, we are strengthening our workforce strategy to ensure we have the right talent, at the right time, in the right way.Job DescriptionThis role will partner with the Sr Director to develop the Clinical Monitoring Oversight program, and to build and manage an internal US CRA (Monitoring) field force. The Associate Director partners with CROs and cross-functional teams to drive monitoring performance and operational excellence at the CRA and site levels by performing targeted and risk-based oversight activities and collaborating with the cross-functional trial team to manage and resolve issues. The Associate Director engages Madrigal sites and networks to develop relationships and support optimal site performance within Madrigal trials. The Associate Director will also manage an internal CRA field team within their region of the US.**Key Responsibilities:****Monitoring Oversight**o Partner with the Sr Director of CRA Field Force to develop and implement the Madrigal Monitoring Oversight program to ensure sponsor oversight of outsourced trialso Utilizing a risk-based approach, perform remote and on-site Monitoring Oversight Visits within a regional US territoryo Document and communicate visit findings to CRO partners and Madrigal stakeholders; assess trends across studies and sites; and manage mitigations, resolutions and CAPAs to remediate identified issues as neededo Provide sponsor support to CRAs and sites at Site Qualification Visits, Site Initiation Visits, and Monitoring Visitso Develop and foster relationships with Madrigal sites within a regional US territory to drive compliance and support optimal performanceo Serve as a Madrigal escalation resource and partner with the CRO, trial team and/or sites to resolve compliance, data and/or monitoring issues**CRA Field Force Team Development and Management**o Partner with the Sr Director of CRA Field Force to develop and implement the internal Madrigal Monitoring programo Build and manage a group of high-performing Madrigal CRAs within a regional US territory (West, Central or East) that monitor Madrigal trialso Contribute to the creation of controlled documents (SOPs, Work Instructions, Job Aids, Templates, Forms) pertaining to Monitoring, and customize for insourced trialso Partner with the Sr Director of CRA Field Force to develop interview, onboarding, andcontinuous education training materials for Madrigal CRAso Strategically allocate internal CRA resources to studies and siteso Review and approve Madrigal CRA Monitoring Visit schedules, reports and expenseso Perform Monitoring Oversight Visits to assess and manage internal CRA performanceo Support internal CRAs and engage with sites at Site Qualification Visits and Site Initiation Visitso Partner with the Sr Director of CRA Field Force and cross-functional stakeholders to develop internal site and monitoring analytics and dashboards to assess site health and monitoring performanceo Customize trial Clinical Site Monitoring Plan for studies monitored by Madrigalo Collaborate with cross-functional stakeholders at Madrigal to ensure trial milestones and goals are met; represent the CRA Field Force team at trial team meetings to share metrics, trends and issues pertaining to sites and monitoringo Conduct site network, site and KOL engagement activities on behalf of Madrigal within a regional US territory**Experience and Professional Qualifications:**o The applicant should be a dynamic leader who thrives within a fast-paced, growing, and collaborative, publicly owned biopharmaceutical companyo Proven track record of successfully managing CRAs across various phases and therapeutic areaso Experience with developing training programs, systems and tools for CRAso Demonstrated ability to influence peers within a matrixed and fast-paced organizationo Strong strategic thinking, problem-solving, and influencing skillso Recent experience with Veeva Vault systems (TMF, CTMS)**Critical Competencies for Success:**o Strong interpersonal capabilities; demonstrates an ability to build and maintain positive site and CRA relationshipso Strong verbal communication and technical writing skillso Fluent in English languageo Ability to present concepts clearly utilizing scientific and regulatory terminologyo Sound organizational skills that support the ability to work independently and efficientlyo Proactive approach to identifying challenges and solutionso Detail-oriented nature paired with critical reasoning skills to identify and resolve issues**Required & Desired Qualifications**· Bachelor’s degree in life sciences, nursing, pharmacy, or related field; advanced degree a plus· 10+ years of clinical operations or monitoring experience, with a minimum of 2+ years in a field CRA role, and additional 2+ years in a prior CRA Manager or Monitoring Oversight (of outsourced monitoring) role· Ability to travel 50%, on averageMadrigal’s Total Rewards strategy is based on a biotech industry peer group comparator and is inclusive of base pay, bonus and equity. Our equity offers meaningful opportunity allowing our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization.All employees receive equity, which we believe reinforces our ownership culture. Base salary is determined by several factors including the candidate’s qualifications, skills, education, experience, business needs and market demands.
As of the date of this posting, a good faith estimate of the current pay scale for this position, applicable to all candidates, is $172,000 - $211,000 per year.
We comply with all applicable minimum wage laws.All full-time employees receive equity, which reinforces our ownership culture and offers meaningful opportunity for our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization.
Full-time employees are also eligible for comprehensive benefits, including flexible paid time off, medical, dental, vision and life/disability insurance, and 401(k) offerings (i.e., traditional, Roth, and employer match) in accordance with applicable plans. We also offer additional voluntary benefits like supplemental life insurance, legal services, and other offerings. In addition, we offer mental health benefits through our Employee Assistance Program for employees and their family. The company also provides other benefits in accordance with applicable federal, state, and local laws.
We #J-18808-Ljbffr