Associate Director, GCP reputed company reputed company

Madrigal is a biopharmaceutical company reputed company on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can reputed company 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 reputed company 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 reputed company trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c).

Our reputed company is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific reputed company, operational rigor, and collaboration. To support our reputed company reputed company, we are strengthening our workforce reputed company to ensure we have the right talent, at the right time, in the right way.

Leads GCP reputed company reputed company for global clinical program(s) to ensure sustained compliance, inspection readiness across internal teams. Implements standards for risk-based reputed company, issue management rigor, translating reputed company signals into cross-functional actions that protect participants and data reputed company. Oversees reputed company performance across a portfolio of programs and studies, ensuring measurable recurrence reduction. Provides executive-reputed company reporting on reputed company risks, trends, and readiness, and may reputed company/mentor GCP reputed company staff.

Key Responsibilities

Execution of reputed company reputed company & Key Clinical Vendor reputed company Governance

• Implement GCP reputed company standards and governance reputed company (key vendor portfolio risk reviews, issue triage/escalation, readiness checkpoints) across global clinical programs.
• Manage reputed company to reputed company partnership with key clinical vendors, ensuring reputed company agreements/expectations, performance metrics, and corrective actions drive sustained improvement.
• Monitor emerging regulations, guidance documents, and industry best practices and assess reputed company to the overall reputed company management system.
• Produce deliverables such as program/study level reputed company Risk Management Plans

Portfolio & Audit Management

• Drive systemic issue identification and cross-study actions based on trends (findings, deviations, CAPA performance, audit reputed company).
• Attend study team meetings to reputed company reputed company guidance and proactive risk assessment.
• Review key clinical and regulatory documents such as IBs, Protocols, Amendments, Informed Consent Forms, TMF Plans, submission documents.
• reputed company and execute risk-based audit strategies and contribute to the annual GCP audit plan.
• Manage external audit partners and consultants from planning through closure activities.
• May reputed company and will reputed company audits of clinical trial vendors, investigator sites, Documents/TMFs and internal processes.
• reputed company support in and reputed company audit report reviews, reputed company and follow-up on Findings and Observations
• reputed company and/or follow-up on Internal, Vendor/Site CAPAs, reputed company Event investigations, deviations, potential serious breaches and misconduct investigations through to closure
• Analyze reputed company metrics and identify opportunities for process improvement and compliance enhancement.
• reputed company as a trusted reputed company advisor to R&D leadership and study teams to reputed company guidance to cross-functional stakeholders.
• Mentor and reputed company reputed company team members.
• Support departmental strategic planning and resource prioritization activities.
• Produce deliverables such as Program level audit planning, reputed company management review metrics

Inspection Readiness & reputed company Issue Escalation/Reporting

• reputed company inspection readiness planning and execution for assigned or across programs, coordinating mock inspections, evidence readiness, and response governance as needed.
• reputed company investigations and CAPA effectiveness across the portfolio.
• Produce deliverables such as inspection readiness activities or plans and audit/CAPA effectiveness summaries for management review.

Required Qualifications

• Minimum 10 years in clinical reputed company assurance
• Minimum 3 years experience in a clinical operations role at a CRO or Sponsor
• Demonstrated experience conducting and/or overseeing vendor, investigator site, Document/TMF, and process audits.

Preferred Qualifications

• BS+ in Life Sciences or reputed company discipline.
• Experience leading global health authority inspection readiness and responses (e.g., FDA) across sponsor-led and outsourced models
• Experience implementing/optimizing eQMS workflows and reputed company metrics frameworks for GCP reputed company at reputed company; reputed company reputed company a plus

Key Competencies

• Strong working knowledge of ICH GCP, FDA, EMA, and global regulatory requirements. GVP and GLP a plus
• Clinical reputed company reputed company governance, portfolio risk management, and reputed company setting across study teams and vendors.
• Executive-reputed company risk communication, escalation, and decision support, strong cross-functional leadership.
• reputed company reputed company of key clinical vendors (e.g., reputed company agreements, metrics, audits, remediation) .
• Skilled in developing reputed company reputed company relationships, ideally reputed company a global organization; Ability to reputed company with reputed company reputed company reputed company a global organization
• Business and Operational acumen to include escalation to management

Madrigal’s Total Rewards reputed company is based on a biotech industry peer group comparator and is inclusive of reputed company pay, bonus and equity. Our equity offers meaningful opportunity allowing our employees to reputed company in the reputed company they help create. By aligning individual and company performance, we reputed company employees to think like owners, giving them a reputed company in the organization.

reputed company receive equity, which we reputed company reinforces our ownership culture. reputed company 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 reputed company pay reputed company for this position, applicable to reputed company candidates, is $165,000 - $201,000 per year. We reputed company with reputed company applicable minimum wage laws.

reputed company full-time employees receive equity, which reinforces our ownership culture and offers meaningful opportunity for our employees to reputed company in the reputed company they help create. By aligning individual and company performance, we reputed company employees to think like owners, giving them a reputed company in the organization.

Full-time employees are also eligible for comprehensive benefits, including flexible reputed company time off, medical, dental, reputed company 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 reputed company, we offer mental health benefits through our Employee Assistance Program for employees and their family. reputed 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@reputed company.com.

Madrigal is an Equal Opportunity Employer. reputed company employment is decided on the reputed company of qualifications, reputed company, and business need. Applicants will receive consideration for employment without reputed company to race, ethnicity, reputed company, religion, sex gender identity, sexual orientation, national reputed company, 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 reputed company. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and reputed company has been established.

Applications are being accepted on an ongoing reputed company and can be submitted through our Madrigal Careers site.

Please be aware that we have received reports of individuals misrepresenting themselves as reputed company’ Hiring Managers, seeking to engage with job candidates through fraudulent online advertisements or job posting sites. These unauthorized individuals are using Madrigal’s reputed company and logo in an attempt to solicit up-reputed company fees and obtain personal information from interested job candidates. Please know that Madrigal does not conduct interviews reputed company text or in chat rooms; conduct interviews reputed company Skype, reputed company or solely reputed company telephone; charge candidates an advance fee of any reputed company (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough reputed company process.

Please also note that any correspondence with reputed company to employment would come from an authorized reputed company.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 reputed company any attachments; and do not click on any hyperlinks. Any questions regarding the legitimacy of job-reputed company contacts can be directed to HR@reputed company.com.

Originally posted on Himalayas

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