Associate Director - IT Clinical Development & Drug Safety/Pharmacovigilance Solutions

Alkermes   •  

Waltham, MA

5 - 7 years

Posted 247 days ago

This job is no longer available.


Alkermes is seeking a seasoned Associate Director of Clinical Development and Pharmacovigilance IT.   This individual is familiar with leading a skilled IT team in implementing Clinical Development IT solutions across the Clinical and Regulatory pharmaceutical space.  They must have experience implementing and supporting Drug Safety and Pharmacovigilance applications.  This individual must be familiar with and adhere to all regulatory compliance.  This individual will be a key member of the IT organization and serve as a primary liaison between various internal and external IT organizations and the Clinical Development and Drug Safety organizations. 

 The role will be based in Waltham MA.


  • Manage and optimize resources within the IT Clinical Development and Drug Safety/Pharmacovigilance Solutions team (direct reports, contractors, consultants and vendors)

  • Lead and manage relationships with Clinical Development and Drug Safety/Pharmacovigilance IT vendors

  • Lead and manage the support of key IT applications for the Clinical Development and Drug Safety/Pharmacovigilance organization

  • Provide leadership, project management and/or implementation support for various Clinical Development and Drug Safety/Pharmacovigilance systems projects and initiatives

  • Elicit requirements using interviews and workshops, document analysis and business process descriptions, use cases, scenarios, business analysis, task and workflow analysis

  • Develop or oversee creation and maintenance of design documents, SOPs, test scripts, user acceptance testing, user documentation, production support documentation, and other relevant deliverables for various Clinical Development and Drug Safety/Pharmacovigilance systems

  • Ensure effective transition of documentation, knowledge transfer, service levels, and training required for production support of new and updated IT solutions and services

  • Serve as the conduit between the stakeholder community (internal and external stakeholders) and various internal and external support teams

  • Ensure appropriate IT processes, procedures, and standards are developed and in place

  • Build and foster effective relationships between the business, external service providers and IT

  • Partner with other global and local IT management to ensure alignment and coordination of IT best practices for all Alkermes users

  • Lead issue resolution and cross-functional problem solving with internal and external technical support providers

  • Manage internal and external service provider quality and performance to ensure that services are delivered according to the specified service levels, requirements, and overall effectiveness

  • Manage project risks in a timely manner to ensure that adverse outcomes are minimized

  • Introduce best practice and process improvement ideas where appropriate

  • Ensure adherence to FDA computer systems validation compliance


 Minimum Education & Experience Requirements:

  • Bachelors Degree in Computer Science, Information Systems, or a related field; post-graduate degree or equivalent experiencepreferred

  • Must have a proven track record to lead a small-to-mid-sized team

  • Minimum of 5-7 years of experiencesupporting / implementing Clinical Development and Drug Safety/Pharmacovigilance systems (or equivalent)

  • Experience managing IT employees in implementing Clinical Development and Drug Safety/Pharmacovigilance IT solutions within a global pharmaceutical company

  • Experience managing Clinical Development and Drug Safety/Pharmacovigilance IT vendor relationships within pharmaceutical/biotech industry

  • Experience with formal software and hardware vendor selection process

  • Demonstrated ability to manage several complex projects at the same time utilizing effective project management best practices

 Technical Knowledge/Skills Needed:

  • Experience with implementing and supporting EDC and IRT within a Pharmaceutical company

  • Experience with SAS, JMP Clinical, TIBCO Spotfire, WinNonLin, Veeva systems

  • Experience with various Clinical Development and Drug Safety/Pharmacovigilance IT system providers a plus

  • Demonstrated project management, continuous improvement, and process maturity skills

  • Excellent verbal and written communication and presentation skills and the ability to interact professionally with a diverse group of executives, managers, and subject matter experts

  • Experience working with third-party partners

  • Experience in biotech and pharmaceutical industry and best practices

  • Knowledge of FDA compliance requirements and ICH guidance

Personal Attributes Needed:

  • Ability to lead IT organizations and related business functions through complex activities and solution implementations

  • Self-starter with ability to multitask – effectively manage simultaneous work requests across Clinical Development and Drug Safety/Pharmacovigilance, IT and other cross-functional organizations, in various geographies

  • Strong work ethic, with a proven track record in successfully achieving goals

  • Ability to initiate, persuade, motivate, and influence project stakeholders and internal/external team members to desired and mutually-beneficial outcomes

  • Strong written and verbal communication and presentation skills

  • Ability to work and manage under straight- and dotted-line scenarios