Immunomedics, Inc.

Senior Director, Clinical Operations

US-NJ-Morris Plains
1 month ago
Job ID
2017-1013
# of Openings
1
Category
Clinical

Overview

We are seeking a Senior Director, Clinical Operations to oversee the successful planning and execution of clinical development and study management plans based on demonstrated clinical expertise, extensive leadership, and operational experience. This individual will provide operational and strategic leadership within the clinical research organization and be responsible for consistent and successful execution of operational aspects of clinical trial studies, with a focus on quality, cost, and timeliness.

Responsibilities

  • Will be accountable for the direction, implementation, execution, and monitoring of all clinical studies, including protocol development and review, investigator and clinical site selection, and CRO/vendor selection and management to ensure the successful filings and approval of INDs and NDAs. 
  • Provide expert advice to senior management for the evaluation of all clinical operations and ongoing interpretation of project findings.  Deliver study progress updates to corporate leadership.
  • Develop study management plans that include enrollment milestones, risk mitigation, financial oversight, communication requirements, monitoring plans, and study progress according to established timelines and goals.
  • Contribute to the writing and review of clinical documents such as NDA, BLA, and IND submissions, protocols, informed consents, investigator brochures, monitoring plans, and clinical study reports.
  • Collaborate and partner with other functional area experts for feedback on study protocols, development plans, publications, etc.
  • Ensure quality of clinical plans, project specifications, study protocols, reports, and other relevant deliverables.  Assist with establishing and approving scientific methods used for the design and implementation of data collection systems, and associated activities.
  • Manage, train, develop, and lead cross-functional teams (e.g., clinical team, study management team, data management team, etc.). 
  • Analyze company goals in relation to new and ongoing projects to ensure appropriate balance between new and ongoing programs, inclusive of budget and resource management.
  • Provide overall administrative and technical direction in support of all emerging clinical projects and collaborate with senior management in assessing requirements.
  • Seek continuous improvement of the quality of group’s deliverables and effective use of applicable technologies within the group and the Company.

Qualifications

  • BA/BS in a scientific or clinical discipline with at least 15 years of progressive work experience in clinical operations, managing clinical programs and personnel in a biotech or pharmaceutical environment. Advance degree preferred.
  • Knowledge and demonstrated proficiency in all areas of clinical operations, including the implementation, monitoring, and management of clinical trials, development process, methods of scientific investigation, data management (e.g., database lock and data analysis), and US and global regulatory requirements and guidelines.
  • Practical and extensive experience in clinical trial strategies, methods, and processes; deep knowledge of clinical trial implementation and management.  Participation in large multi-center and/or global trials, investigational site and CRO management, data collection study protocol compliance, and accountability for budget/timelines.
  • Demonstrated track record of translating senior level clinical research/scientific business requirements into operational strategies.
  • Solid understanding of US and global regulations and guidelines (e.g., FDA, EMA, ICH) applicable to clinical development; prior success in partnering with regulatory peer to support timely and quality regulatory submissions.
  • Excellent verbal, written, analytical, and presentation communication skills.  Adept at creating and communicating a clear vision among direct reports and cross-functional teams, effectively aligning resources and motivating teams to achieve goals. Must also be able to effectively communicate with colleagues and associates outside the organization to create partnership-style relationships.
  • Demonstrated technical, organizational, project management, and negotiation capabilities. 
  • Strong experience in oncology and autoimmune diseases.
  • Experience with Phase I – IV clinical trials.

 

Salary will be commensurate with experience, plus a comprehensive benefit program.  

 

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