Immunomedics, Inc.

Director, Clinical Operations

Job Locations US-NJ-Morris Plains
Posted Date 3 months ago(2/25/2020 9:35 AM)
Job ID
2020-1647
# of Openings
1
Category
Clinical

Overview

This position will be responsible for the clinical operational strategy and overall delivery of clinical trial(s). This position will be responsible for clinical operations planning, oversight and execution of the most complex global studies within one or more clinical development programs. As a clinical operations expert this role includes three primary accountabilities.  First, development and coordination of operational approaches and delivery.  Second, cross-functional team leadership for critical global studies.  And third, oversight of and interactions with CROs and other external vendors to ensure studies are conducted according to timelines, budget and quality plans. 

Responsibilities

• Develops, leads and manages clinical operations activities for one or more global clinical trials.
• Leads cross-functional teams in the delivery of clinical studies to plan, quality and cost. Provides expertise and consultation to project teams to facilitate problem resolution, successful outcomes and quality results.
• Ensures site selection, patient recruitment, monitoring and study closeout are optimized for delivery and compliance. Develops program level country selection and site identification strategies. Ensure robust approaches are in place for all studies across one or more clinical programs that support enrollment of the right patient population and accurate end point data.
• Manages and mentors clinical operations staff and cross-functional team members.
• Oversees CRO and provides timely input to ensure that the study is executed according to the agreed project plan. Specifically, tracks major study milestones and monitors overall operational performance metrics through the life of the study. Analyzes CRO performance trends within a clinical study or across several studies and resolves or escalates accordingly.
• Completes a study risk assessment and ensures mitigation and contingency measures are prepared and implemented. Monitors study level risk management activities and ensures risk mitigation plans are in line with program needs.
• Be aware of, and be able to predict, deviations or potential noncompliance concerns (at a protocol level, site level, study level) and rapidly resolve or escalate to appropriate governance.
• Effectively partners with cross functional program level leads to ensure operational plans for clinical studies are in line with program level goals.
• Provides strategic input to clinical development plans and develops operational strategies to meet program needs across multiple studies.
• Ensures appropriate timeline tracking systems and CTMS are in place to support program execution.
• Partners with biostatistics, medical and other functions in regular data reviews, identify and implement corrective actions or improvements.
• May be expected to lead a program of studies involving co-development (Alliance) partners.
• Collaborates with Clinical Digital Solutions team to ensure a state of inspection readiness for all TMFs and ensures quality expectations are met.
• Drives creation of the budget at study start up and monitors the overall agreed budget against trial progress. Will also be responsible for Budget forecasting of studies.
• Contributes to the identification, design and implementation of process improvements, in conjunction with management team(s).
• Partners with Medical Affairs to develop program wide approaches to recruitment, advocacy, Key Opinion Leaders, Steering Committees, etc.
• Interfaces and communicates with stakeholders across functions (program management, regulatory, legal, finance, commercial, etc.).
• Maintains a positive, results orientated work environment, building partnerships and modeling teamwork as well as communicating in an open and objective manner.
• In the absence of Clinical Study Manager, the Director will be expected to take both strategic and tactical roles to deliver the study.

Qualifications

• Bachelor's Degree is required, preferably in a scientific/clinical discipline. An advance degree in scientific, clinical research or regulatory affairs, or business/finance is preferred.
• At least 15 years of clinical operations experience with a Biotechnology/Pharmaceutical company leading Phase I - IV multinational clinical studies. Extensive Phase 3 experience is desired.
• Extensive experience, 10 plus years, with CRO management, contracting, oversight and managing study execution through CROs, possibly including prior work experience with a CRO.
• 10 plus years of cross-functional team project management experience. PMP certification desirable.
• 3 plus years of direct line leadership of clinical operations staff; 5 plus years desired.
• 5 plus years of oncology and autoimmune experience is desired.
• Clinical development plan and protocol development experience as well as program and study level operational strategy experience are important.

• Demonstrated experience in the successful strategic planning and execution of all clinical study activities using in-house resources and external resources.
• Solid understanding of US and Global regulations and guidelines applicable to clinical development.
• Strong ability to manage and motivate team across a global virtual team in a demanding and fast-paced environment.
• Extensive experience for financial oversight of a global clinical development program is desirable.
• Proven excellence in operational strategy and demonstrated ability to execute operationally.
• Advanced ability to work in a matrix environment and develop constructive partnerships with internal and external stakeholders.
• Demonstrated ability to deal with time demands, incomplete information or unexpected events.
• High degree of motivation; results oriented.
• Excellent negotiation skills, analytical and problem-solving skills.
• Strong ability to manage multiple and varied tasks and prioritize workload.

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