Vice President Clinical Operations – Woburn, MA
Reporting to Replimune’s Chief Medical Officer, and as a member of the Replimune Management team, the Vice President of Clinical Operations (VP,CO) will be responsible for directing the Clinical Operations function of the company, developing and implementing the overall Clinical Operations strategy. The VP,CO has responsibility for building, developing and leading a Clinical Operations organization appropriate for the evolving needs of Replimune. This individual will oversee the execution of studies, recruitments, study monitoring, safety monitoring, data management, data analysis, clinical trial vendor selection, management and oversight. The VP, CO will also support the development of study protocols and any other documents supporting clinical trials and regulatory submissions. He or she will also have responsibility for managing timelines and clinical development budgets and resources and will oversee the development of and adherence to trial operations standard operating procedures (SOPs).
- Provide leadership to all Clinical Operations team, including both internal staff in the US and UK and external resources
- Oversee or develop department policies, SOPs and other required documents, including clinical trial protocols, work instructions, manuals
- Develop and implement processes to build appropriate infrastructure for Clinical Operations to successfully plan, execute and report on clinical trials that support corporate objectives
- Responsible for ensuring operational excellence to a high standard such that the clinical trial conduct meets all appropriate best industry practices, regulatory requirements, partner requirements
- Responsible for ensuring adherence to GCP such that all company trials can meet current clinical trial quality standards
- Develop systems that allow for clear, accurate and current views of all trial status, key operations metrics, study quality and vendor performance metrics.
- Oversee and direct resource allocation for conduct of all clinical studies including both internal and external resource models.
- Prepare, review and monitor all clinical trial budget projections and expenditures to ensure adherence to budget
- Responsible for oversight of clinical trial vendor negotiation and contracting
- Keep current on latest developments in clinical operations particularly with regard to monitoring practices, data management practices.
- Manage staff of Clinical Operations and ensure roles are performed and staff are appropriately trained
- Represent the Clinical Operations Department and provide updates to Replimune Senior Management
- Advanced degree, or BS degree in science, nursing, health or related field; Advanced degree would be a plus
Experience and Skill Requirements:
- Minimum 15 years relevant industry experience managing projects and working with clinical professionals within a team, as well as working in a cross-functional product development team.
- Effectively overseen the Clinical Operations function in relation to late stage oncology clinical development program(s) at a senior level, such program(s) including hundreds of patients in multiple countries, ideally in relation to multiple products in parallel – minimum 5 years’ experience at the functional leadership level is required.
- Must have a demonstrated track record to independently manage and provide significant tactical, technical and leadership guidance to clinical operations team.
- Must have a demonstrated track record of effective liaison with other key functions, including Clinical, Regulatory & Quality, Finance, CMC and pre-clinical
- Demonstrated knowledge and a clear understanding of the overall drug development process, including experience with all phases of the clinical research process and global (US, EU) regulatory requirements (i.e. GCPs, CFRs, etc.)
- Deep understanding of financial metrics with a proven ability to maintain operational control through the use of metrics and process ownership.
- Prior demonstrated experience hiring and managing Clinical Operations employees and overseeing Clinical Operations teams.
- Experience in building the infrastructure that is required to effectively support the Clinical organization.
- Highly developed organizational abilities and project management skills. Requires strong organizational, presentation, documentation and interpersonal skills as well as a willingness to work within a team-oriented environment.
- Computer skill should include proficiency with Microsoft Office software.
- Travel requirement: 20% or more travel required – domestic and international
EEO & Employment Eligibility:
Replimune is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, ancestry origin, disability or veteran status. Replimune also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.
Replimune, Inc. does not accept agency resumes unless contacted directly by internal Replimune Talent Acquisition.
Please do not forward resumes to our careers site, employees or any other company location of Replimune. Replimune will not be responsible for any fees related to unsolicited resumes.