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Associate Director, Clinical Operations at Mallinckrodt Pharmaceuticals

Posted in Other 30+ days ago.

Location: Bedminster, New Jersey





Job Description:

Job Title

Associate Director, Clinical Operations

Requisition

JR000011814 Associate Director, Clinical Operations (Open)

Location

US Specialty Brand Headquarters - USA501

Additional Locations

Hampton, NJ

Job Description

Summary

The Associate Director, Clinical Operations role is a "player-coach" position, responsible for oversight and management of company-sponsored clinical trials, as well as direct line management of staff. The AD, Clinical Operations is responsible and accountable for the forecasting, management, execution and reporting on clinical trial operations for single-center and multicenter clinical trials which span the entire clinical development lifecycle (i.e., Phases 1-4). In addition to clinical trial-related responsibilities, the AD, Clinical Operations will also manage and mentor Clinical Trial Managers and/or Clinical Trial Associates. The AD, Clinical Operations will also serve as the Business Owner/Functional Representative on process improvement and/or non-project-related initiatives to make our operations more efficient and effective.


This individual will be part of the Global Development Operations department in Science and Technology (S&T) and will provide expertise to multidisciplinary Project Teams in support of Clinical Development plans and Mallinckrodt strategic imperatives. The position is expected to perform largely autonomously in the execution of assigned clinical trials, but will operate under the guidance of a Director, Clinical Operations. If applicable, this position will also work in conjunction with the Principal Investigator(s) of federally-funded grants and contracts.

Principal Responsibilities


  • Manage all aspects of clinical trials including: assessing operational feasibility and recommending study execution plan; developing and managing comprehensive study timelines and metrics; participating in selection and management/oversight of external vendors; reviewing vendor reports, budgets, and metrics; providing study-specific training and leadership to clinical research staff, including CRO, CRAs, Clinical Sites and other contract personnel; preparing and presenting project debriefings, as required; planning, executing, and leading study-specific meetings; and if applicable, ensuring compliance with all federal regulations and contractual obligations including Federal Acquisition Regulations (FAR) applicable to external funding agencies.

  • In collaboration with the Director, Clinical Operations, identifies and evaluates internal and/or external resources required to efficiently run the clinical operations team.

  • Ensure internal project team members are aware of their roles and responsibilities as members of the study team in order to streamline internal activities related to study conduct.

  • Ensure all clinical trials are executed in compliance with national/international GCP guidelines/regulations and SOPs/WIs

  • Participate in the planning of Quality Assurance activities and coordinates resolution of audit findings.

  • Ensure audit-ready condition of Clinical Trial Master Files associated with their studies.

  • Provide leadership and guidance to Clinical Operations staff to ensure duties are being met.

  • Develop, review and monitor comprehensive trial-related budgets.


  • Implement approved clinical trial protocols and operational plans, which are consistent with strategic corporate and S&T objectives and assume primary accountability for the ongoing progress of those plans on assigned studies.

  • Collaborate with Procurement and other appropriate functions in the selection of CROs and vendors.


  • Provide routine status reports and updates to the VP, Global Development Operations regarding the progress of programs.

  • Proactively identify risks to study timelines and budgets and propose risk mitigation strategies/solutions

  • Work with the Director, Clinical Operations to develop and achieve corporate goals, as well as, with Clinical Operations staff to achieve the established corporate goals within the expected time frames

  • Ensure strategic goals and objectives are set and communicated to direct reports.

  • Ensure timely and optimal allocation of internal staff to projects in accordance with agreed-upon priorities and if applicable, in conjunction with the Principal Investigator(s) of federally-funded grants and contracts as appropriate.

  • Coach and ensure direct reports receive appropriate knowledge and skill development and growth opportunities.

  • Supervise multiple trials depending on phase of development, size of study population, and number of centers in the trial.

Department specific/Non-essential responsibilities:


  • Identify opportunities to optimize/enhance processes and/or systems and autonomously lead process improvement/non-project-related initiatives

  • Other duties as assigned with or without accommodation.

Minimum Requirements

Experience / Skills:

  • BA/BS degree or higher, preferably in the life sciences.

  • Must have at least 8+ years successfully managing clinical trials and 3+ years managing clinical operations Staff.

  • Previous experience in leading project operational teams through clinical trial start-up, conduct, data management, and report writing.

  • Experience in writing, reviewing and editing protocols and clinical study reports.

  • A working knowledge of Guidelines and FDA regulations.

  • The ability to exercise judgment and determine appropriate action.

  • Ability to manage deadlines and budgets and a proven ability to provide solutions to a variety of technical problems of moderate scope and difficult complexity.


  • Strong leadership skills and experience in leading project operational teams.

  • Experience with managing clinical trials, including global trial experience.

  • Broad knowledge of drug development processes, in particular those directly related to R&D and clinical operations.

  • Demonstrated ability to problem-solve, build teams, lead and motivate others.

  • Proficient in the use of Microsoft Office applications (e.g., MS Word, PowerPoint, Excel, Project).

  • Ability to apply sound business judgment and take corrective actions, resolve problems and negotiate settlements.

  • Strong communication skills to explain complex concepts to management and/or stakeholders.

  • Ability to lead multidisciplinary teams and leverage individual skills.

  • Ability to act decisively and professionally in an uncertain environment.

  • Aptitude to compile, analyze and present data in concise manner.

  • Successful track record with metrics, project management and supplier relationship management.

  • Prior experience and demonstrated success in working with PIs and research coordinator teams required.

  • Ability to write clinical reports, protocols, business correspondence, and procedure manuals.

  • Ability to set priorities and process multiple internal and external customer demands.

  • Strong active listening skills and ability to articulate and formulate decisions and actions in a clear business language

Competencies:


  • Proven leadership skills including the capability to rally stakeholders and their resources around the unit's and company's goals.

  • Ability to motivate and drive decision-making within a cross-functional and cross-cultural, global team structure.

  • Must possess a combination of strategic perspective / critical thinking, managerial courage and proven effectiveness within complex business structures. Track-record of driving difficult decisions to conclusion. Ability to lead and influence various teams without authority.

  • Ability to work in a virtual setting/across time-zones and make effective use of communication tools (WebEx and video conferencing).

  • Ability to listen effectively and the capability to effectively communicate ideas and data both verbally and in writing in a persuasive and appropriate manner to a broad array of stakeholders.

  • Self-driven individual able to function with minimal supervision.

  • Proficient with MS Office products and other technology tools.

  • Travel approximately: ~10-20% to resolve field issues and meet with Service Providers.

Organizational Relationship/Scope:

Reports to: Director, Clinical Operations

Direct Reports for the AssociateDirector, Clinical Operations: CTMs, CRAs, CTAs and other Development Operations Managers/Clinical Operations professionals

Working Conditions:

This position can be located in Hampton, NJ or remote-based for the appropriate candidate.

Standard office environment.

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