Executive Director, Operations Lead is accountable for the management of clinical trials and programs across the product life cycle as well as the resourcing, development, training and management of a successful clinical operations team.
Responsibilities:- Create, execute and proactively manage clinical trial processes from initial study planning to implementation and conduct through final close-out.
- Define the tactics and manage the daily operational activities to ensure that timelines and deliverables are consistently met.
- Provide leadership, strategic oversight, and guidance of Clinical Operations to ensure quality, timeline, resources and budget goals are met.
- Establish performance indicators and apply to ensure the successful execution of clinical trials to agreed timelines.
- Ensure the effective and constructive integration of clinical operations knowledge and expertise into all applicable Clinical Development activities including integrated development plans and study protocols; interact and collaborate with other department heads as appropriate.
- Demonstrated ability to review proposals and budgets from potential CRO partners as a part of the selection process. Participate in proposal review meetings for CRO selection.
- Review and collaborate to negotiate investigator grant budgets to ensure consistent with protocol-required tests and procedures and representative of fair market value in accordance with Madrigal standards.
- Represent all aspects of Clinical Operations and provide updates as required to the Executive Committee, Project Teams, Board of Directors and other key internal stakeholders.
- Lead & mentor Clinical operations staff to support successful internal training and its implementation and serve as an advocate for professional development of Clinical Operations staff.
- Oversee, plan and implement Quality Checks for clinical projects and provide leadership and direction to ensure the highest standards for compliance with Company SOPs, ICH-GCP guidelines, Regulatory authority regulations and patient safety standards.
- Mentor clinical operations staff on the Regulatory Inspections process and develop a pro-active approach for Inspection readiness.
- Assist the QA department in the development, review and updating of clinical SOPs.
- Accountable for the authorship of operational sections of protocols and investigator brochures, and leading the identification of and interaction with investigative sites and investigators, including study execution.
- Develop and maintain strong relationships with CROs, external experts and Investigators to ensure effective execution of internal and external clinical projects.
- Coordinate with Biometrics to deliver high quality data deliverables on time and on budget (e.g. development of case report forms, collaboration with statisticians, collaboration with data managers, data overview, clinical study reports, etc.).
- Provide support for regulatory submissions, supporting dossier development and participating in interactions with FDA, EMA and other regulatory agencies.
- Keep abreast of competitive regulatory and clinical practices and utilize this knowledge during the ongoing development and adjustment of plans.
Requirements:- Bachelors in Life Sciences, Nursing Licensure or Pharmacy; an advanced degree (MS or PharmD) is preferred.
- A minimum of 10 years of experience with expertise in the areas of clinical operations development and strategic planning; developing, implementing, and leading early to late stage clinical trials.
- In-depth understanding and experience across the clinical operations value chain, with a track record of success in study planning, execution, data cleaning, database locking, study report generation and regulatory inspection. Relevant therapeutic area experience coupled with experience with pivotal, multi-site, multi-national clinical trials.
- Experience with global drug development and NDA filing; experience in developing protocols, SOPs, Clinical Study Reports, INDs, NDAs, as well as other clinical, regulatory, and safety documents.
- Experience collaborating closely with cross functional teams to meet study deliverables on time and on budget.
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 $285,789 - $333.848 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.
