Associate Director – Clinical Operations

Socket.dev; Boston (MA); Hybrid; USD 140,000 - 180,000; Full time

Job summary

Monte Rosa Therapeutics is seeking a highly experienced Clinical Operations professional to lead the planning, implementation, and conduct of clinical trials across multiple indications. The Associate Director, Clinical Operations will develop operational program strategy and drive First in Human through Phase III trials, while representing operations on cross-functional Core Teams.

The role requires 10+ years of global clinical trial and program operations experience, oncology or

Qualifications

• Bachelor's degree in health sciences or related field.
• Minimum of 10 years of global clinical trial and program operations experience with at least 4 years of independent clinical trial management through all phases of clinical trial execution (Start-up, maintenance, closeout).
• Robust experience in oncology and/or autoimmune and inflammatory diseases required.
• Experience with managing and demonstrating oversight of CROs, vendors and consultants.
• Extensive knowledge and application of current FDA Regulations, ICH/GCP guidelines in clinical trials.
• Strong computer skills including knowledge of Excel, Word, PowerPoint, Outlook and MS Project/Smartsheet.

Responsibilities

• Accountable for delivery of assigned clinical program and study budgets, timelines, and resource management with focus on quality, including making recommendations and decisions regarding operational strategies to support study and/or program objectives.
• Collaborate with Medical Director(s) and cross functional teams on the development, planning, and execution of clinical operations program strategy for multiple indications.
• Represent Clinical Operations at cross functional core team meetings.
• Lead and oversee execution of assigned clinical trials to ensure all trial deliverables are met according to established timelines, goals, budget, and quality standards.
• Manage the cross functional study management team and CRO/vendor(s) related to all aspects of clinical trial operations.
• Establish study timelines and ensure accurate tracking and reporting of study metrics.
• Develop and execute Clinical Trial Operations Strategy and other operational, vendor management and oversight plans.
• Lead identification, RFP/bid defense, and selection of CRO/third party vendors.
• Accountable for the development, management, and tracking of trial budget as well as accuracy of trial information; provide ongoing reporting and forecasting to finance.
• Manage and provide documented oversight of CRO and third-party vendors to ensure quality and adherence to ICH/GCP standards as well as established study timelines.
• Contribute to development of clinical documents including the clinical trial protocol, Investigator’s Brochures, Informed Consent Forms, responses to questions from IRBs and Ethics Committees.
• Contribute to clinical sections of IND summary documents, CTAs for initiation of studies ex-US, and responses to questions from regulatory authorities.
• Develop strong relationships with Investigators, site staff, and CRO partners.
• Oversee Data Management in partnership with Medical Director(s) to develop Data Review Plan and co-lead execution of routine cross functional data review for defined study/program milestones (Dose Escalation Meetings, Interim Analysis, Annual Safety reports, IB Updates, Database Lock, CSR, Publications, etc.) including performing clinical data review to ensure the highest standard of data quality.
• Collaborate with Head of Clinical Operations to define and monitor key performance indicators and departmental metrics, as well as identification of opportunities for process optimization, training needs, and procedures (SOPs, Work Instructions).
• Ensure consistent practices with the highest ethical standards in compliance with internal SOPs, ICH/GCP, and local regulations.
• Represent clinical operations to external stakeholders including key opinion/thought leaders.

Skills

Communication

Collaboration

Leadership

Negotiation

Education

Bachelor's degree in health sciences or related field

Tools

Excel

Word

PowerPoint

Outlook

MS Project

Smartsheet

Job description

Overview

Monte Rosa Therapeutics is seeking a highly experienced Clinical Operations professional to lead the successful planning, implementation, and conduct of clinical trials across multiple indications. Reporting to the Head of Clinical Operations, the Associate Director, Clinical Operations will be responsible and accountable for development of operational program strategy and leading execution of First in Human through Phase III trials depending on program lifecycle, representing clinical operations on cross functional Core Teams, and managing clinical operations team members to ensure adherence with overall study timelines, budget, quality, and regulatory standards (ICH/GCP, internal SOPs). A genuine interest and understanding of the science supporting the MRT pipeline, an ability to work in a multidisciplinary team setting, and a commitment to developing new treatments for patients are critical for success.The candidate will have the ability to work Hybrid work arrangement with Boston office MRTx requires a 70% office presence..Availability for approximately 30–40% travel is required for site visits, co-monitoring, investigator meetings, and select international activities.

Responsibilities

• Accountable for delivery of assigned clinical program and study budgets, timelines, and resource management with focus on quality, including making recommendations and decisions regarding operational strategies to support study and/or program objectives.
• Collaborate with Medical Director(s) and cross functional teams on the development, planning, and execution of clinical operations program strategy for multiple indications.
• Represent Clinical Operations at cross functional core team meetings.
• Lead and oversee execution of assigned clinical trials to ensure all trial deliverables are met according to established timelines, goals, budget, and quality standards.
• Manage the cross functional study management team and CRO/vendor(s) related to all aspects of clinical trial operations.
• Establish study timelines and ensure accurate tracking and reporting of study metrics.
• Develop and execute Clinical Trial Operations Strategy and other operational, vendor management and oversight plans.
• Lead identification, RFP/bid defense, and selection of CRO/third party vendors.
• Accountable for the development, management, and tracking of trial budget as well as accuracy of trial information; provide ongoing reporting and forecasting to finance.
• Manage and provide documented oversight of CRO and third-party vendors to ensure quality and adherence to ICH/GCP standards as well as established study timelines.
• Contribute to development of clinical documents including the clinical trial protocol, Investigator’s Brochures, Informed Consent Forms, responses to questions from IRBs and Ethics Committees.
• Contribute to clinical sections of IND summary documents, CTAs for initiation of studies ex-US, and responses to questions from regulatory authorities.
• Develop strong relationships with Investigators, site staff, and CRO partners.
• Oversee Data Management in partnership with Medical Director(s) to develop Data Review Plan and co-lead execution of routine cross functional data review for defined study/program milestones (Dose Escalation Meetings, Interim Analysis, Annual Safety reports, IB Updates, Database Lock, CSR, Publications, etc.) including performing clinical data review to ensure the highest standard of data quality.
• Collaborate with Head of Clinical Operations to define and monitor key performance indicators and departmental metrics, as well as identification of opportunities for process optimization, training needs, and procedures (SOPs, Work Instructions).
• Ensure consistent practices with the highest ethical standards in compliance with internal SOPs, ICH/GCP, and local regulations.
• Represent clinical operations to external stakeholders including key opinion/thought leaders.
• Additional duties and responsibilities as required.

Qualifications

• Bachelor's degree in health sciences or related field.
• Minimum of 10 years of global clinical trial and program operations experience with at least 4 years of independent clinical trial management through all phases of clinical trial execution (Start-up, maintenance, closeout).
• Robust experience in oncology and or autoimmune and inflammatory diseases required.
• Demonstrated experience with developing clinical operations strategy and plans including site monitoring, risk mitigation plans, recruitment plans, enrollment modeling and CRO/vendor oversight plans.
• Experience with managing and demonstrating oversight of CROs, vendors and consultants
• Extensive knowledge and application of current FDA Regulations, ICH/GCP guidelines in clinical trials.
• Strong computer skills including knowledge of Excel, Word, PowerPoint, Outlook and MS Project/Smartsheet.
• Outstanding ability to communicate in an open and clear manner, listening effectively and inviting response and discussion with internal partners and external service providers.
• Ability to collaborate effectively with the study team, cross-functional team members and external partners (including investigator and site staff) using collaborative negotiation skills.
• Proficient in risk management to prevent and overcome complex safety and compliance related issues during clinical program implementation.
• Comfortable in a fast paced, results-driven, highly accountable environment with large potential impact.
• 20% travel required.