BeOne Medicines I GmbH
Associate Director, Regional Program Lead(m/w/x)
Full-timeOn-siteManagement
Basel
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IRIronwood Pharmaceuticals
Clinical Operations Lead(m/w/x)
Basel
Full-timeOn-siteSenior
Nejo AI Summary
Managing CRO/vendor activities and clinical trial execution for GI disease treatments, including LINZESS® and apraglutide development, at a GI healthcare company. 14 years pharmaceutical/Biotech clinical development/operations experience with broad global trial management required. Focus on pioneering treatments for rare GI diseases.
Requirements
- High motivation and results orientation
- Bachelor's degree
- 14 years pharmaceutical/Biotech clinical development/operations experience
- Broad global clinical trial management experience
- Knowledge of Program and Project Management principles/practices
- Significant experience managing Phase I-IV trials
- Global oversight of CROs and vendors
- Advantageous: Rare disease trial experience
- Proven large team management ability
- Oversight/partnering with CROs and teams
- Intense drive and organizational expertise
- Strong GCP/ICH proficiency
- Knowledge of U.S. drug development process and global clinical trials regulatory expectations
- Excellent interpersonal, oral, written communication skills
- High-level decision-making ability
- Strategic thinking
- Initiative with incomplete information
- Team motivation ability
- Active collaboration
- Healthy debate
- Continued learning
Tasks
- Oversee program delivery and operational CRO/vendor activities for development programs.
- Oversee clinical trial execution within programs.
- Ensure excellence in service delivery from CROs, consultants, and contractors.
- Meet trial milestones while adhering to quality, timeline, and budget.
- Manage clinical programs.
- Collaborate with clinical development, regulatory, data management, biostatistics, drug supply, medical writing, and drug safety teams.
- Support creation and maintenance of clinical development plans.
- Provide operational input on program budget, timelines, and vendors.
- Oversee CTT performance, metrics, and milestones.
- Ensure compliance with regulatory standards, ICH-GCP, protocol, and company procedures.
- Support study selection decisions.
- Negotiate Scope of Work (SOW) with vendors, consultants, and contractors.
- Ensure vendor delivery against contracted SOW.
- Manage vendor budgets and performance.
- Manage vendor issues.
- Develop and manage program timelines and budgets.
- Oversee trial subject retention.
- Identify potential risks and implement mitigations.
- Identify best practices for trial efficiency.
- Identify opportunities for enhanced quality.
- Onboard, coach, and mentor Development Operations team members.
- Foster a team culture of ownership and engagement.
- Promote continuous improvement and recognize team successes.
- Supervise and line manage employees.
- Oversee employee development and goal setting.
- Manage employee performance processes.
- Contribute to the strategic vision and long-term plans of Development Operations.
- Support optimal resource utilization and prioritization.
- Support optimal organization of infrastructure and staff.
- Identify and eliminate team impediments.
- Report and escalate issues, concerns, and roadblocks to management.
- Interact regularly with senior management on functional and vendor matters.
- Contribute to developing and implementing Development Operations policies and SOPs.
- Perform other assigned duties.
Work Experience
- 14 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- GCP/ICH
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Ironwood Pharmaceuticals and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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IRIronwood Pharmaceuticals
Clinical Operations Lead(m/w/x)
Basel
Full-timeOn-siteSenior
Nejo AI Summary
Managing CRO/vendor activities and clinical trial execution for GI disease treatments, including LINZESS® and apraglutide development, at a GI healthcare company. 14 years pharmaceutical/Biotech clinical development/operations experience with broad global trial management required. Focus on pioneering treatments for rare GI diseases.
Requirements
- High motivation and results orientation
- Bachelor's degree
- 14 years pharmaceutical/Biotech clinical development/operations experience
- Broad global clinical trial management experience
- Knowledge of Program and Project Management principles/practices
- Significant experience managing Phase I-IV trials
- Global oversight of CROs and vendors
- Advantageous: Rare disease trial experience
- Proven large team management ability
- Oversight/partnering with CROs and teams
- Intense drive and organizational expertise
- Strong GCP/ICH proficiency
- Knowledge of U.S. drug development process and global clinical trials regulatory expectations
- Excellent interpersonal, oral, written communication skills
- High-level decision-making ability
- Strategic thinking
- Initiative with incomplete information
- Team motivation ability
- Active collaboration
- Healthy debate
- Continued learning
Tasks
- Oversee program delivery and operational CRO/vendor activities for development programs.
- Oversee clinical trial execution within programs.
- Ensure excellence in service delivery from CROs, consultants, and contractors.
- Meet trial milestones while adhering to quality, timeline, and budget.
- Manage clinical programs.
- Collaborate with clinical development, regulatory, data management, biostatistics, drug supply, medical writing, and drug safety teams.
- Support creation and maintenance of clinical development plans.
- Provide operational input on program budget, timelines, and vendors.
- Oversee CTT performance, metrics, and milestones.
- Ensure compliance with regulatory standards, ICH-GCP, protocol, and company procedures.
- Support study selection decisions.
- Negotiate Scope of Work (SOW) with vendors, consultants, and contractors.
- Ensure vendor delivery against contracted SOW.
- Manage vendor budgets and performance.
- Manage vendor issues.
- Develop and manage program timelines and budgets.
- Oversee trial subject retention.
- Identify potential risks and implement mitigations.
- Identify best practices for trial efficiency.
- Identify opportunities for enhanced quality.
- Onboard, coach, and mentor Development Operations team members.
- Foster a team culture of ownership and engagement.
- Promote continuous improvement and recognize team successes.
- Supervise and line manage employees.
- Oversee employee development and goal setting.
- Manage employee performance processes.
- Contribute to the strategic vision and long-term plans of Development Operations.
- Support optimal resource utilization and prioritization.
- Support optimal organization of infrastructure and staff.
- Identify and eliminate team impediments.
- Report and escalate issues, concerns, and roadblocks to management.
- Interact regularly with senior management on functional and vendor matters.
- Contribute to developing and implementing Development Operations policies and SOPs.
- Perform other assigned duties.
Work Experience
- 14 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- GCP/ICH
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Ironwood Pharmaceuticals and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
Ironwood Pharmaceuticals
Industry
Pharmaceuticals
Description
Ironwood Pharmaceuticals is a global gastrointestinal healthcare company focused on advancing GI disease treatment and redefining patient care. They are pioneers in LINZESS® and are developing apraglutide for rare GI diseases.
Not a perfect match?
- BeOne Medicines I GmbH
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Full-timeOn-siteManagementBasel - 1201 F. Hoffmann-La Roche AG
Global Clinical Operations Excellence Lead - Study Systems Lead(m/w/x)
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Full-timeOn-siteManagementBasel - 1201 F. Hoffmann-La Roche AG
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