Scorpion Therapeutics
Director/Sr. Director, Clinical Operations (Oncology Experience Required)
Scorpion Therapeutics, Boston, Massachusetts, us, 02298
Scorpion is a pioneering clinical-stage oncology company redefining the frontier of precision medicine to deliver optimized and transformational therapies for larger populations of patients with cancer. Scorpion has built a proprietary and fully integrated platform of the most advanced technologies across cancer biology, medicinal chemistry, and data sciences, with the goal of consistently and rapidly creating exquisitely selective small molecule compounds against an unprecedented spectrum of targets. Scorpion aims to leverage its platform to advance a broad pipeline of wholly owned, optimized compounds across three target categories: best-in-class molecules targeting validated oncogene targets; first-in-class molecules for previously undruggable targets; and first-in-class molecules for novel cancer targets.
Job Summary:
The Director/Sr. Director - Clinical Operations is responsible for providing leadership to assigned Clinical Program(s) and for ensuring studies (Phase I-IV) within a program are being managed in accordance with the company's overall program goals, timeline, budget and quality expectations. This individual is responsible for ensuring clinical trials within a Clinical Program are in compliance with the company's procedures, FDA, regulations, GCP, ICH requirements and any other applicable regulations. The Director/Sr. Director - Clinical Operations is a member of the Leadership Team within the Clinical Operations Department and as such, this person will play a key role in contributing to the culture of the department, building strong relationships with other key functions within the organization, and will have direct line management responsibilities.
Job Responsibilities:
Responsible and accountable for the operational strategy and overall execution of assigned clinical program(s).Oversee a team of internal clinical operations professionals (either through direct line management or matrix management) working on the assigned clinical program(s) from start-up through close-out to ensure that both internal and external deliverables are on time and on budget.Work cross-functionally to coordinate the relevant and timely exchange of information and materials to support clinical program delivery.Ensures program and trial inspection readiness.Provide clinical operations technical expertise in the development of documents and processes, where needed.Member of assigned program(s) core team providing strategic direction to meet corporate goals and timelines.Evaluate CRO/vendor performance and support improvement initiatives/governance.Act as an escalation point for study-level team members.As a member of the Clinical Operations Leadership Team, this role will contribute significantly to the development and implementation of functional initiatives for role clarity, the way we work, and best practices.Participate in the creation, authoring, review, and updating of clinical operations related SOPs, including evaluating the need for new SOPs.Manage direct and indirect reports, providing training, coaching, and development for team members.Skills & Qualifications:
Bachelor's Degree is required, advanced degree preferred, with a minimum of 10 years of experience inOncology experience is required.Extensive vendor management and project management skills are critical.Excellent written and oral communication skills.Strong problem-solving skills and solution-minded approach. Able to quickly identify problems, analyze the issue and rapidly develop solutions.Strong working knowledge of GCP/ICH and other applicable regulations/guidelines is required.Good organizational/prioritization skills with strong attention to detail and an eye for quality.Strong proficiency with MS Office programs such as Outlook, Word, Excel, PowerPoint, and SharePoint is required.A collaborative spirit for working successfully with cross-functional teams and partners is essential.Ability to travel, including internationally, 10-20%.
Scorpion Therapeutics Inc. is an Equal Opportunity Employer who strives to create and maintain a diverse working environment. We do not discriminate for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Job Summary:
The Director/Sr. Director - Clinical Operations is responsible for providing leadership to assigned Clinical Program(s) and for ensuring studies (Phase I-IV) within a program are being managed in accordance with the company's overall program goals, timeline, budget and quality expectations. This individual is responsible for ensuring clinical trials within a Clinical Program are in compliance with the company's procedures, FDA, regulations, GCP, ICH requirements and any other applicable regulations. The Director/Sr. Director - Clinical Operations is a member of the Leadership Team within the Clinical Operations Department and as such, this person will play a key role in contributing to the culture of the department, building strong relationships with other key functions within the organization, and will have direct line management responsibilities.
Job Responsibilities:
Responsible and accountable for the operational strategy and overall execution of assigned clinical program(s).Oversee a team of internal clinical operations professionals (either through direct line management or matrix management) working on the assigned clinical program(s) from start-up through close-out to ensure that both internal and external deliverables are on time and on budget.Work cross-functionally to coordinate the relevant and timely exchange of information and materials to support clinical program delivery.Ensures program and trial inspection readiness.Provide clinical operations technical expertise in the development of documents and processes, where needed.Member of assigned program(s) core team providing strategic direction to meet corporate goals and timelines.Evaluate CRO/vendor performance and support improvement initiatives/governance.Act as an escalation point for study-level team members.As a member of the Clinical Operations Leadership Team, this role will contribute significantly to the development and implementation of functional initiatives for role clarity, the way we work, and best practices.Participate in the creation, authoring, review, and updating of clinical operations related SOPs, including evaluating the need for new SOPs.Manage direct and indirect reports, providing training, coaching, and development for team members.Skills & Qualifications:
Bachelor's Degree is required, advanced degree preferred, with a minimum of 10 years of experience inOncology experience is required.Extensive vendor management and project management skills are critical.Excellent written and oral communication skills.Strong problem-solving skills and solution-minded approach. Able to quickly identify problems, analyze the issue and rapidly develop solutions.Strong working knowledge of GCP/ICH and other applicable regulations/guidelines is required.Good organizational/prioritization skills with strong attention to detail and an eye for quality.Strong proficiency with MS Office programs such as Outlook, Word, Excel, PowerPoint, and SharePoint is required.A collaborative spirit for working successfully with cross-functional teams and partners is essential.Ability to travel, including internationally, 10-20%.
Scorpion Therapeutics Inc. is an Equal Opportunity Employer who strives to create and maintain a diverse working environment. We do not discriminate for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.