- Manage clinical program and study budgets, timelines, and resources while focusing on quality.
- Work closely with Medical Directors and cross-functional teams to plan and execute clinical operations strategies.
- Represent Clinical Operations in core team meetings.
- Oversee the implementation of clinical trials to meet objectives within set timelines, budget, and quality benchmarks.
- Supervise the study management team and CRO/vendors involved in trial operations.
- Establish study timelines, track progress, and report on study metrics accurately.
- Develop and implement Clinical Trial Operations Strategy and oversee vendor management plans.
- Lead the selection and management of CRO and third-party vendors.
- Responsible for trial budget development, management, and reporting.
- Ensure CROs and vendors adhere to standards and study timelines.
- Collaborate on clinical document development and responses to regulatory inquiries.
- Build strong relationships with Investigators, site staff, and partners.
- Manage clinical supply activities and Data Management in alignment with study milestones.
- Supervise team members, support their professional growth, and manage performance.
- Work with the Head of Clinical Operations to monitor departmental metrics and identify process optimization opportunities.
- Contribute to resourcing plans for clinical studies and ensure timely allocation of resources.
- Ensure compliance with internal SOPs, ICH/GCP guidelines, and regulations.
- Represent clinical operations to external stakeholders including thought leaders.
- Hold a Bachelor's degree in health sciences or a related field.
- Minimum of 10 years' experience in global clinical trial and program operations.
- Specialize in oncology and/or autoimmune and inflammatory diseases.
- Proven experience in developing clinical operations strategy and overseeing CRO/vendor management.
- Demonstrated expertise in FDA Regulations and ICH/GCP guidelines.
- Strong communication skills and ability to collaborate effectively.
- Proficient in risk management and adaptive operational planning.
- Comfortable in a fast-paced, results-oriented environment.
- Expect some travel, around 20%.
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Director, Clinical Operations – Inflammation - Boston, United States - Monte Rosa Therapeutics
2 weeks ago
Description
Director, Clinical Operations – Inflammation
Location: Boston, MA
Join our team at Monte Rosa Therapeutics as we are looking for a seasoned Clinical Operations expert to take charge of planning, implementing, and overseeing clinical trials across different areas. As the Director of Clinical Operations, you will play a crucial role in shaping operational strategies, leading trial executions from initial stages to Phase III, and ensuring the team follows study timelines, budget, quality, and regulatory standards. Passion for science, teamwork, and dedication to advancing patient care are key to excelling in this role.
Key Responsibilities:
Skills & Qualifications
Excited about this opportunity? Send us your CV and Cover Letter to explore further.
Monte Rosa Therapeutics is at the forefront of developing molecular glue degrader medicines for patients with serious illnesses like cancer and autoimmune diseases. Our innovative approach combines AI-guided chemistry and advanced technologies to target specific proteins, offering hope where traditional treatments fall short. Join us in our mission to discover groundbreaking therapies and make a real difference in patients' lives.
