OrphAI Therapeutics is a fast-growing company with a mission to develop new therapeutics for patients with unmet needs. The company has two ongoing Phase 2 clinical trials and is rapidly expanding its clinical operations.
We are now seeking a Head/Senior Director of Clinical Operations to continue to build our capabilities and provide expert planning and management of our clinical studies.
The position can be either remote or based out of our Guilford CT office.
Responsibilities Include
Responsible for the operational strategy and leadership of all the clinical program(s) which includes focus on budget, timelines, contracts resource management and providing operational strategies in support of achieving clinical program objectives.
Develop and actively manage clinical trial recruitment strategies with evaluation of actual enrollment against assigned targets and working with investigational sites to meet, and whenever feasible, exceed enrollment targets. Ensures compliance with SOP’s, GCP and ICH guidelines.
Develop and coordinate operational plans for a clinical study or multiple clinical studies within a development program (i.e. study timeline projection, drug and budget forecast, safety plan, monitoring plan, study management plan, issue escalation and resolution plan).
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.
Responsible for the selection, oversight and performance of CROs, Contract Laboratories and other vendors for assigned programs.
Represent the company at clinical sites and external project meetings as required.
Responsible for the clinical section and overall development update for DSUR/annual report and Investigator’s Brochure.
Develop the clinical trial budget for multiple programs
Manage Clinical Operations financial planning/forecasting and budget management and monitor the budget against actuals.
Recognized as a clinical operation leader by other functions and ability to represent and lead cross functional initiatives.
Matrix leader of cross-functional global Clinical Program Team responsible for operational strategy for assigned clinical program; serves as main point of contact for regional, global or cross functional issues, including any CRO/ vendor performance issues and Clinical Program Team resource issues.
Plan, track and run all activity throughout the project lifecycle, including deliverables from all functional areas and vendors to the project scope.
Develop project plans, timelines, status reports and communicate with all applicable team members in and outside the organization.
Promote effective partnership among cross-functional teams and provide day to day direction for core team.
Meet with team members on a regular basis regarding project tasks to ensure project achievements.
Serve as primary project contact with vendors.
Manage CRO and site budgets, communicate deviations from budget projections, and propose solutions for budget deviations.
Lead problem solving and resolution efforts. Provide dedicated and creative recommendations on how to meet goals and handle identified risks and deviations.
Ensure that work is conducted in compliance with professional standards and SOPs and meet quality and timeline metrics.
Build and maintain strong sponsor and CRO team relationships for the success of clinical trial management.
Lead proposal development and bid-defense process.
Manage IP distribution, planning, reconciliation, and ordering
Qualifications
BS/BA degree in a scientific or health related discipline. Advanced scientific or equivalent experience (MS) preferred.
Minimum of 10 years if experience in drug development, clinical research and operational strategy experience including responsibility ensuring studies and programs are executed to quality, timelines and budget. (at least part of this time in a Biotech/Pharma environment is preferred)
Small biotechnology company experience a plus.
Demonstration of project/program management skills including risk assessment, timeline and budget management and contingency planning
Demonstration of effective team leadership of matrix teams.
Excellent communication, management and organizational skills, along with problem solving, conflict resolution, and team building skills
Experience across several complex therapeutic areas
Scientifically and clinically agile, proven ability to learn and apply relevant disease information into strategic operational planning and delivery
Deep operational expertise
Experience planning and delivering US based and global clinical programs and studies
Experience facilitating the development of Clinical Development Plans (CDPs) with multiple functions strongly desired
Multi-study experience managing early through late-stage clinical trials.
Working knowledge of, and experience with, clinical trial design, conduct, data acquisition and reporting
Working knowledge and understanding of key regulatory authorities, ICH Guidelines and Good Clinical Practice (GCP)
Seniority level
Director
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Biotechnology Research
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