Versanis Bio is a privately held, clinical-stage biopharmaceutical company bringing transformational treatments to people living with cardiometabolic disease. Bimagrumab is the lead Versanis Bio program and currently in late phase 2 clinical development, with a goal of helping overweight and obese adults achieve and maintain a healthy body composition.
Versanis Bio fosters an innovative and collaborative environment focused on employee personal growth and accountability. We are seeking self-motivated employee with a passion for improving lives of patients and their families.
The Associate Director collaborates with the Head of Clinical Operations and Study Leads to oversee and execute on regional and global trials, in assigned clinical program(s) in compliance with quality standards, support oversight of CROs and other third-party vendors to meet the Company’s obligations described in ICH-GCP and the Company’s objectives.
- Manage all clinical aspects of study including assessment and selection of Contract Research Organizations (CROs), sites, and other vendors; solicit and review proposals; review or negotiate budget and Scope of Work; assess operational feasibility.
- Provide subject matter expertise and operational input into study documents and execution plans to ensure compliance with the Company’s SOPs as required.
- Develop and manage comprehensive study budgets, timelines, and metrics. Review contracts and change orders.
- Assist Clinical Study Leads in the development and maintenance of study oversight and management plans.
- Liaise with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationships.
- Oversee performance for all activities assigned to a CRO/vendor, including escalation of issues to Head of Clinical Operations and Quality Assurance team when required.
- Contribute to initiatives to identify and implement best practices and continuous improvement plans in Clinical Operations.
- Identify risks, develop/implement mitigation strategies, and escalate issues that may jeopardize timelines, quality, or deliverables.
- Provide operational leadership for inspection-readiness.
- Identify opportunities to optimize processes/procedures; lead and/or participate in process development and process improvement initiatives.
- Ability to travel up to approximately 10-20%.
- Perform other duties as required and assigned by supervisor.
- A minimum of bachelor’s degree in science or a health-related field; advanced scientific degree preferred.
- A minimum of 10 -12 years of direct clinical trial management experience, including operational/project management experience in a Sponsor setting.
- In-depth knowledge of clinical trial operations, ICH-GCP Guidelines and other applicable regulatory requirements. Phase 3 experience preferred.
- Experience mentoring and directing members of clinical operations teams
- Experience working in a team across multiple functional areas (e.g., Regulatory, Quality Assurance, Finance, Data Management, Biostats, Pharmacovigilance, Clinical Supply Chain)
- Strong, analytical communication (verbal and written), project management, and business partnering skills.
- Team player with a positive and collaborative outlook
- Job description reflects general details to describe the principle functions of this job, the level of knowledge and skill typically required, and the scope of responsibility and should not be considered an all-inclusive listing of work requirements. Individual may perform other duties as assigned related to study programs.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be constructed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside their normal responsibilities from time to time, as needed. Versanis Bio an Equal Employment Opportunity, M/F/D/
To apply, please send a current resume/CV and cover note to email@example.com.