Associate Director, Clinical Site Management and Monitoring Oversight
Madrigal Pharmaceuticals, California City, California, us, 93504
Overview
Madrigal 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. This 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 Partner with the Sr Director of CRA Field Force to develop and implement the Madrigal Monitoring Oversight program to ensure sponsor oversight of outsourced trials Utilizing a risk-based approach, perform remote and on-site Monitoring Oversight Visits within a regional US territory 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 needed Provide sponsor support to CRAs and sites at Site Qualification Visits, Site Initiation Visits, and Monitoring Visits Develop and foster relationships with Madrigal sites within a regional US territory to drive compliance and support optimal performance 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 Partner with the Sr Director of CRA Field Force to develop and implement the internal Madrigal Monitoring program Build and manage a group of high-performing Madrigal CRAs within a regional US territory (West, Central or East) that monitor Madrigal trials Contribute to the creation of controlled documents (SOPs, Work Instructions, Job Aids, Templates, Forms) pertaining to Monitoring, and customize for insourced trials Partner with the Sr Director of CRA Field Force to develop interview, onboarding, and continuous education training materials for Madrigal CRAs Experience And Professional Qualifications The applicant should be a dynamic leader who thrives within a fast-paced, growing, and collaborative, publicly owned biopharmaceutical company Proven track record of successfully managing CRAs across various phases and therapeutic areas Experience with developing training programs, systems and tools for CRAs Demonstrated ability to influence peers within a matrixed and fast-paced organization Strong strategic thinking, problem-solving, and influencing skills Recent experience with Veeva Vault systems (TMF, CTMS) Critical Competencies For Success Strong interpersonal capabilities; demonstrates an ability to build and maintain positive site and CRA relationships Strong verbal communication and technical writing skills Fluent in English language Ability to present concepts clearly utilizing scientific and regulatory terminology Sound organizational skills that support the ability to work independently and efficiently Proactive approach to identifying challenges and solutions 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 average Madrigal’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 are committed to providing reasonable accommodations for individuals with disabilities throughout the hiring process. If you need assistance, please contact HR@madrigalpharma.com. Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law. Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established. Applications are being accepted on an ongoing basis and can be submitted through our Madrigal Careers site. Please be aware that we have received reports of individuals misrepresenting themselves as Madrigal Pharmaceuticals’ Hiring Managers, seeking to engage with job candidates through fraudulent online advertisements or job posting sites. These unauthorized individuals are using Madrigal’s name and logo in an attempt to solicit up-front fees and obtain personal information from interested job candidates. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process. Please also note that any correspondence with regard to employment would come from an authorized madrigalpharma.com email address or from an email address from one of our trusted search firm partners. We are aware that incorrect/fraudulent email addresses, with Madrigal misspelled, have been utilized in these most recent fraud attempts. If you receive unsolicited employment offers from people claiming to work for or on behalf of Madrigal, we recommend that you: do not respond to their questions; do not open any attachments; and do not click on any hyperlinks. Any questions regarding the legitimacy of job-related contacts can be directed to HR@madrigalpharma.com.
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Madrigal 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. This 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 Partner with the Sr Director of CRA Field Force to develop and implement the Madrigal Monitoring Oversight program to ensure sponsor oversight of outsourced trials Utilizing a risk-based approach, perform remote and on-site Monitoring Oversight Visits within a regional US territory 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 needed Provide sponsor support to CRAs and sites at Site Qualification Visits, Site Initiation Visits, and Monitoring Visits Develop and foster relationships with Madrigal sites within a regional US territory to drive compliance and support optimal performance 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 Partner with the Sr Director of CRA Field Force to develop and implement the internal Madrigal Monitoring program Build and manage a group of high-performing Madrigal CRAs within a regional US territory (West, Central or East) that monitor Madrigal trials Contribute to the creation of controlled documents (SOPs, Work Instructions, Job Aids, Templates, Forms) pertaining to Monitoring, and customize for insourced trials Partner with the Sr Director of CRA Field Force to develop interview, onboarding, and continuous education training materials for Madrigal CRAs Experience And Professional Qualifications The applicant should be a dynamic leader who thrives within a fast-paced, growing, and collaborative, publicly owned biopharmaceutical company Proven track record of successfully managing CRAs across various phases and therapeutic areas Experience with developing training programs, systems and tools for CRAs Demonstrated ability to influence peers within a matrixed and fast-paced organization Strong strategic thinking, problem-solving, and influencing skills Recent experience with Veeva Vault systems (TMF, CTMS) Critical Competencies For Success Strong interpersonal capabilities; demonstrates an ability to build and maintain positive site and CRA relationships Strong verbal communication and technical writing skills Fluent in English language Ability to present concepts clearly utilizing scientific and regulatory terminology Sound organizational skills that support the ability to work independently and efficiently Proactive approach to identifying challenges and solutions 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 average Madrigal’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 are committed to providing reasonable accommodations for individuals with disabilities throughout the hiring process. If you need assistance, please contact HR@madrigalpharma.com. Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law. Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established. Applications are being accepted on an ongoing basis and can be submitted through our Madrigal Careers site. Please be aware that we have received reports of individuals misrepresenting themselves as Madrigal Pharmaceuticals’ Hiring Managers, seeking to engage with job candidates through fraudulent online advertisements or job posting sites. These unauthorized individuals are using Madrigal’s name and logo in an attempt to solicit up-front fees and obtain personal information from interested job candidates. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process. Please also note that any correspondence with regard to employment would come from an authorized madrigalpharma.com email address or from an email address from one of our trusted search firm partners. We are aware that incorrect/fraudulent email addresses, with Madrigal misspelled, have been utilized in these most recent fraud attempts. If you receive unsolicited employment offers from people claiming to work for or on behalf of Madrigal, we recommend that you: do not respond to their questions; do not open any attachments; and do not click on any hyperlinks. Any questions regarding the legitimacy of job-related contacts can be directed to HR@madrigalpharma.com.
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