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Director / Senior Director, Clinical Operations

Boston, MA

Posted: 12/01/2019 Employment Type: Direct Hire Job Category: Clinical: Clinical Operations and Development Job Number: 2485

Job Description

Reporting to VP, Clinical, the Director / Sr. Director, Clinical Operations will have the important role of leading operations and working with an integrated team of Clinical Operations professionals to advance the development of leading indication in both phase 2 and 3 clinical trials, while working toward planned studies of rare genetic disorders of obesity. S/he will play a central role in establishing and having oversight responsibilities for the collaboration, effective management, and communication with multiple external partners, including global vendors and stakeholders (CROs, central labs, IRBs, and other external partners). This role will promote relationship development both internally across functional groups, and externally with vendors, KOLs, Investigators and Study Coordinators.

The Director / Senior Director, Clinical Operations will oversee the operational aspects of all clinical studies worldwide through providing resources, standard processes, and strategic operational direction for clinical trial execution. Overseeing clinical trial partners and working with internal team members, the Director will proactively identify, manage, and communicate risks to key stakeholders, peers, and senior management, then work alongside to establish solutions with the highest quality for safety and effectiveness.

Responsibilities and Duties:
  • Maintains an overview of status, issues, or risks across programs to effectively communicate to all stakeholders
  • Ensures internal consistency across studies and ensures alignment of operational programs
  • Identify risks, develop/implement mitigation strategies, and escalate issues that may jeopardize timelines and deliverables
  • Identifies opportunities to optimize processes and procedures
  • Support the development and implementation of global clinical operations strategy
  • Plan and identify resources for global clinical studies based on company priorities, project timelines and staff competencies.
  • Centralize activities in study start up, maintenance and close out that are common to all trials
  • Standardize adherence to global clinical standards
  • Business technology expert participating in system selection and implementation of emerging business technologies used during the study (e.g., EDC, IRT, CTMS, TMF)
  • Governs alliances with strategic partners, including CROs and other vendors, to ensure operational plans, timelines, and budgets are aligned with corporate objectives and standards, as well as program goals
  • Leads interdisciplinary activities by coordinating and collaborating with internal teams to set goals and timelines, formulates strategies for execution, and escalates issues that may jeopardize timelines, quality or deliverables
  • Maintains awareness of industry trends and developments to innovate and promote future strategic direction for clinical programs, studies, vendors, systems, and sites
  • Holds accountability for and participates in long-range financial planning by working with Clinical Operations staff and Finance to develop budgets, projections, accruals and track financial status against program-level budget
  • Provides operational leadership for inspection-readiness
  • Leads and/or participates in process development and process improvement initiatives
  • Responsible for all operational aspects of clinical trials, ensuring compliance with GCP’ s, SOPs, and standards and in compliance with FDA, EMA, GCP, and ICH guidelines

Qualifications and Skills:
  • A minimum 12-15+ years of direct clinical trial management experience, including operational / project management experience
  • A minimum of BS Degree in science or a health-related field
  • Team leadership and operational excellence experience
  • Line management experience preferred
  • Ability to anticipate, timely escalate issues and to define appropriate action plans
  • Ability to work cross-functionally fostering team spirit and team motivation
  • Ability to work in an international environment with internal and/or external partners
  • Able to successfully communicate complex concepts and data to a variety of audiences
  • Expert knowledge of global regulatory and compliance requirements for clinical research, including US CFR, EU CTD, local country requirements and ICH GCP
  • Registration (NDA/MAA) submission experience
  • Deep understanding of managing external relationships, specifically with Investigators, advisors, other study personnel, clients and vendors
  • Ability to communicate effectively at all levels and in a highly collaborative team environment

Meet Your Recruiter

Aaron Goldman
Clinical Recruitment Team Lead

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past five years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!
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