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Associate Director , Clinical Operations


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  • Beacon Hill Staffing Group - Pharma
  • 12/05/18
  • Boston, MA
  • 02108
  • Full-Time
This key role will manage, plan and execute clinical studies. Key areas of focus include developing and managing budgets, operational plans and timelines in the context of both in-house and outsourced operating models. Additionally, s/he will provide guidance and shared learnings with and across teams throughout planning and implementation, as well as ensure deliverables and timelines are met, and in compliance with SOPs, Regulatory Authorities and ICH/GCP guidelines.
Role and Responsibilities
Operationalization of asset-level integrated development plans across clinical development deliverables;
Serve as the Sponsor representative to lead, plan, and execute discovery, translational research and clinical study related activities (Phases 1-3), including management, budget and timeline creation in concert with Contract Research Organizations (CROs) and external vendors;
Contribute to the evaluation, selection and management of CROs and external vendors to ensure successful implementation and execution;
Liaise with vendors, clinical site staff and Investigators as appropriate to ensure optimal Sponsor relationships;
Author protocols, informed consent forms (ICFs), clinical study reports (CSRs) and other discovery and translational research documents as necessary;
Manage all aspects of project deliverables from planning to close-out to assure adherence to intended timelines and achievement of corporate goals while ensuring quality in accordance with FDA, EMEA, GCP and ICH guidelines;
Develop and ensure execution of activities outlined in various operational plans (e.g., data management, safety management, risk mitigation and study communication plans);
Participate in preparation of regulatory documents (e.g. IND, pre-IND, orphan applications etc.) as needed;
Partner with CMC/clinical supply vendors/contractors to provide assumptions to the asset-level integrated development plan;
Ensure adequate Sponsor oversight of investigative sites, CROs and vendors to enable Quality Assurance (QA) in execution activities;
Co-monitor or monitor clinical studies if needed to support program deliverables; and
Light administrative duties (e.g. scheduling meetings, expense reports, executive travel, etc.) as needed to support Cambridge office executives.

Requirements
Masters degree preferred in a scientific or healthcare discipline;
Minimum of 4-6 years of professional experience focusing on drug development in the biotech/pharmaceutical industry, at least 2 years of direct operational management work preferred. Late stage clinical trial experience preferred.
Understanding of drug development from discovery through NDA, including global/international studies or programs;
Extensive experience managing multiple discovery and development programs, CROs, vendors and budgets;
Strong working knowledge of developing Gantt charts and timelines;
Excellent oral, written, clinical and scientific communication skills;
Protocol, ICF, and/or CSR writing experience;
Ability to organize and manage multiple priorities;
Flexibility to complete tasks beyond primary position to support corporate needs;
Ability and willingness to travel 20% of the time (international and domestic);
Experience in neuroscience and/or rare disease therapeutic area(s) is strongly preferred; and
Innovative, patient-centric mindset.


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