Senior Director Clinical Informatics
Proclinical is currently recruiting for a Senior Director of Clinical Informatics with a biotechnology company located in Boston, MA. Successful candidate will partner closely with the Clinical leadership to design and deliver digital solutions and to pioneer new and better ways to use digital to execute clinical trials and regulatory submissions.
- Partner with business stakeholders in Clinical Operations, Regulatory, Pharmacovigilance, and Quality to design, deploy, and maintain digital solutions to support their needs.
- Assist with the internal integration engineering team to build validated system integrations and deliver automation of processes, user management, and master data management.
- Partner with the internal application engineering and data science teams to deploy custom-built solutions as needed.
- Partner with the IT infrastructure team to ensure cloud infrastructure for internally hosted systems is fit for purpose.
- Develop and evolve a multi-year Digital Clinical roadmap in partnership with Clinical leads.
- Explore cutting edge technologies such as AI, wearables, read-world evidence, and virtual trials.
- Manage a team to deploy validated commercial off-the-shelf Clinical systems in partnership with external technology vendors.
- Ensure all systems adhere to applicable regulatory, quality, legal, and compliance requirements through the entire system lifecycle and remain up to date on evolving regulations.
- Improve and streamline existing systems and digital-enabled processes to improve quality, user experience, and flexibility.
- Build strong relationships with Clinical leads and manage ongoing roadmap updates to leadership.
Skills and Requirements:
- Bachelor's degree in Computer Science, Information Technology, Biotechnology or equivalent required. Master's degree preferred.
- 15+ years of leadership experience delivering digital solutions in an enterprise environment with 10+ years of experience with clinical systems/solutions (both GCP and non-GCP).
- Deep understanding of clinical development and the business needs and priorities of a late-stage clinical organization.
- Demonstrated experience partnering with Clinical, Regulatory, and Pharmacovigilance functions.
- Strong understanding of GCP, GVP, GLP, and clinical business processes.
- Experience in business analysis, processing mapping, strategic roadmapping, and digital transformation.
- Deep experience with computer systems validation (CSV) and a proven track record of delivering and maintaining validated systems.
- Proven experience with numerous Clinical, Regulatory, and Pharmacovigilance systems (EDC, eTMF, CTMS, IRT, Safety Database, RIM, etc.)
- Solid understanding of technical concepts of single-sign-on (SSO), data warehousing, analytics, cloud computing, and system integration.
- Experience managing technical vendors and outsourced providers.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Felix Hook at (+1) 646-367-2617 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.