Job Description
Seeking experienced Associate Director to lead clinical process improvement and drive operational excellence in a dynamic and innovative environment.
We're looking for a highly skilled professional to join our team as Associate Director Clinical Processes & Solutions. This role is responsible for leading and driving operational and scientific excellence through clinical process improvement across the portfolio. This includes but is not limited to driving updates of standard operating procedures, templates, guidance, and trainings. This position also serves as a clinical representative on cross-functional governance boards and development initiatives.
Your responsibilities will include:
* Drive the update of clinical document templates such as Clinical Trial Protocol, Investigator Brochure, Clinical Data Review, and Clinical Development Plan according to clinical guidance.
* Participate and represent Clinical Development on important strategic cross-functional projects as defined by Clinical Development Leadership Team.
* Drive cross Clinical Development and Global Line Function alignment of processes as part of the deliverables of Clinical Development and drive implementation at the Unit level.
* Lead QA/SOP activities within Clinical Development, which includes coordinating Subject Matter Experts (SME) identification; applying clinical applicability; performing collegial reviews of SOPs, templates, and processes.
* Can serve as a Lead SME or as an SME for clinical process-related work such as protocol deviations.
* Drive best practices by identifying clinical training needs and development opportunities.
* Identify cross-functional issues, gaps, and lead global process improvement work streams as applicable.
* In collaboration with QA, responsible to implement quality initiatives as needed: inspection readiness, records tracking, support audits preparation and follow-up.
* Drive efficiency and track performance against metrics.
* From a people standpoint, work with the Clinical Development to make sure that Clinical Development Leadership is informed at all points about key issues and has access to information when needed.
As Associate Director Clinical Processes & Solutions, you will be part of a global team that is committed to delivering innovative solutions that improve and extend people's lives. Our purpose is to reimagine medicine, and our vision is to become the most valued and trusted medicines company in the world.
Requirements:
* Advanced degree in life sciences/healthcare (or clinically relevant degree)
* Strong understanding of Pharmaceutical Development processes
* ≥5 years technical and operational experience in planning, executing, reporting, and publishing clinical studies in industry or Academia
* Thorough knowledge of Good Clinical Practice
* Strong scientific background in basic and clinical research
* Strong skills in leading and managing cross-functional projects with significant business impact
* Excellent interpersonal and communication skills with influencing, negotiation, and conflict resolution skills
* Excellent analytical, process-oriented, and data-driven mind-set
* Act as change agent and actively generate and foster creativity and innovation in CD
* Leadership presence with the ability to present and interact with senior management
