Director, Clinical Operations - Clinical Development, Remote US

POINT Biopharma is an innovative, high-performance company focused on a hard problem: creating new cancer therapies that are more effective and have fewer side effects than traditional treatments. Our products are targeted radioligands, a technology that hold significant promise to treat cancer. Our company is growing rapidly: we just announced a phase 3 clinical trial for our novel radioligand based prostate cancer treatment, established our U.S. manufacturing center in Indianapolis, and have a pipeline of next generation oncology products in development. We are a creative and agile team accountable to a high standard: to be uniquely better. If you are searching for new and uniquely better career path, you should consider joining the POINT team.

TO BE CONSIDERED, APPLICANTS MUST BE LEGALLY ENTITLED TO WORK IN THE USA.

Location of work

The position will be working remotely with the anticipation of travel for team and client meetings. Our business requirements are to work to accommodate Eastern Time Zone. To work in synergy, it is preferred that our applicants can work Eastern Time Zone to accommodate team and client meetings.

Overview

Reporting to the Sr. Director Strategic Business Operations & Program Delivery, the Director, Clinical Operations will be a member of the Clinical Development leadership team and serve as the strategic direction and oversight leader of Clinical Trial Operations, including mentorship and guidance to external and internal teams. Serving as the Clinical Operations Functional expert, the incumbent will be responsible for clinical operations leadership relating to the direction, planning, execution, conduct and oversight of POINT Sponsored Clinical Trials.

Objectives

• Serve as an operational program leader on the clinical development team by providing direct oversight and management of Clinical Operations activities, ensuring clinical trials are appropriately resourced; team members work to the POINT standards, compliance is maintained with established SOPS, working guidelines, project plans and regulatory requirements.
• Communicate project status, including risk identification and escalation of ongoing issues to Sr. Leadership to ensure timely decision-making and overall risk mitigation
• Provide project level oversight of clinical trials, to cross functional teams- including data management, clinical supply, safety, regulatory operations, clinical science and biometrics.
• Support the ongoing development and evolution of Clinical Operations infrastructure by contributing to the Standard Operation Procedures (SOPs) framework, working practice documents, POINT standards, key performance indicators and team benchmarks
• Lead the Clinical Operation team(s) including in-house team members and Contract Research Organizations (CROs), vendors and other suppliers to ensure work quality, timeliness and adherence to budget.
• Propose and champion fit-for-purpose resourcing strategies, including services to be performed in-house vs. outsourced, in-licensing of technologies and 5-year planning
• Provides technical support and guidance (including project scope, risk identification, escalation and mitigation, resource planning, goals and deliverables) the full team working within the assigned program.
• Understands and manages project/program inter-dependencies to achieve program milestones/deliverables.
• Conducts evaluations and implements required changes for all projects (including mid-project recovery of at-risk projects, re-scoping, postponement, or cancellation).
• Measure and reports Key Performance Indicators (KPIs) and lead continuous improvement.
• Manage trial level budgets, communicates deviations from budget projections, and propose solutions for budget deviations.
• Develops and actively manages clinical trial recruitment strategies with evaluation of actual enrollment against assigned targets and work with investigational sites to meet, and whenever feasible, exceed enrollment targets.
• Assure compliance with regulatory requirements by monitoring overall study compliance of CRO’s, vendors, etc. with company standard operating procedures (SOPs), GCP, FDA and applicable international regulations.
• Promote effective partnership among cross-functional teams and provides day to day direction for core team. Leads problem solving and resolution efforts. Provides dedicated and creative recommendations on how to meet goals and handle identified risks.
• Acts as line manager and mentor to Clinical Program Leads and other team as assigned, supporting professional development initiatives and overall engagement and performance
• Manages workload of supervised staff with continued assessment and adjustment as needed.
• Provides on-going feedback, development and coaching of direct