Associate Director Program Operations Leader

An Associate Director Program Operations Leader (POL) is responsible for leadership and overall strategic management of one or more complex programs in Clinical Trial Management (CTM). You will be responsible for clinical operations activities and decisions including quality, timelines and budgets related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations and company Standard Operating Procedures (SOPs) within assigned program(s). The POL is a member of the Clinical Trial Management extended leadership team, and as such interacts with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research project and department initiatives. The POL is responsible for line management of clinical trial management staff, including responsibility for staff recruitment, development, coaching, mentoring and performance management.

A TYPICAL DAY AS A POL LOOKS LIKE:

• Responsible for the overall success of the clinical study team(s) within a program(s)


• Maintains an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or changes that may impact quality, timelines and/or budget; provide clinical program level updates to stakeholders as requested


• Provides operational insight into feasibility, timeline and cost estimates during clinical program/study development


• Oversees clinical study timelines within a clinical program(s)


• Provides input and operational insight into Clinical Study Concepts (CSC)


• Review of plans and provision of clinical operations expertise during protocol design, feasibility, study start up and conduct phases of studies. Ensure consistency within the program and development of best practices within CTM


• Oversees clinical study budgets within a program: ensures review, presentation and approval of initial study budget and manages the budget through the lifecycle of the program by communicating changes to TA Operations Leader, as appropriate


• Ensures timely delivery of quality operational deliverables and accountable for ensuring consistency of process and approaches across clinical study teams within the clinical program(s).


• Drives decision making and integrates all operational considerations for studies within a clinical program(s) to ensure goals are attainable prior to implementation


• Acts as point of contact for clinical program and study level escalation


• Reviews key metrics and Key Performance Indicators (KPIs) across studies and within clinical program(s) to track study progress


• Provides proactive creation and implementation of risk mitigation strategies


• Provides innovative and flexible operational solutions and options to the cross functional and development teams; assists in preparing scenarios for creative solutions to operational challenges


• Drives the strategy and oversight for vendor selection and management within a clinical program(s)


• Manages the Clinical Research Organization (CRO) and vendor(s) as it relates to clinical program level deliverables and relationship with key CRO (functional and project) and vendor counterparts


• Identifies and recommends changes to practices and policies, including initiating and participating in strategic projects, initiatives, and continuous improvement projects within Global Development


• Attends and represents CTM for a program(s) at review committee meetings as appropriate


• Participates in CRO governance meetings as needed for clinical program(s)


• Participates in Joint Meetings with Collaborative Partners at the study level and program level


• Ensures inspection readiness throughout the clinical program lifecycle and is the cross functional leader for Regulatory Authority Inspections


• Responsible for CTM resource forecasting and resource allocation for clinical studies across one or more clinical programs


• Responsible for direct supervision of CTM staff. Line management responsibilities include: work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight.


• May require up to 25% travel


TEAM MEMBERSHIP AND KEY INTERFACES:

Key Team Membership:

• CTM Leadership Team


• Vendor Governance Committee(s)


• Clinical Operations Review Meeting(s)


• Development Team(s)


• Clinical Compliance Meeting(s)


• Strategy Review Meeting(s)


Cross Functional Interfaces

• Interface with key clinical and regulatory functional area leads


• Project Management


• Medical Director(s)


• Procurement


• Clinical Finance
  
  Strong interpersonal & leadership skills


• Ability to provide strategic direction and guidance for clinical programs


• An understanding of relevant industry trends


• Analytical skills with a data driven approach to planning, executing, and problem solving


• Effective communication skills via verbal, written and presentation abilities


• Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization


• Ability to influence and negotiate


• Budget management experience


• Ability to build productive teams and collaborations


• Strong project management, cross-functional team leadership and organizational skills


• Demonstrated vendor management experience


• Line management experience with demonstrated mentoring and coaching skills


• Extensive experience in global clinical trial operations


• A working knowledge of GCP and ICH


In order to be considered qualified for this role a minimum of a Bachelor's degree and minimum of 12 years relevant industry experience, 8 years within the function is requireed. Advanced degrees may be considered in lieu of relevant experience