Job Title: Program Operations Leader
This role is a hybrid position requiring at least 3 days on-site in one of our offices. As the Program Operations Leader, you will lead and implement the operational strategy for delivery of one or more complex programs in Clinical Trial Management (CTM).
You are 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 programs.
You will interact with senior level management, external vendors, collaboration partners, and clinical study personnel for clinical research project and department initiatives.
As a line manager of clinical trial management staff, you are responsible for recruitment, development, coaching, mentoring, and performance management.
You play a key role in driving the functional strategy of Clinical Trial Management in partnership with Functional leadership.
The Director POL is expected to operate with autonomy and high-degree of independence.
Responsibilities:
* Be responsible for the overall success of the clinical study team(s) within a program(s)
* Maintain an overview of clinical program(s) status and issues, proactively communicate progress, risks, issues, or changes that may impact quality, timelines, and/or budget
* Provide clinical program level updates to partners as requested
* Provide operational insight into feasibility, timeline, and cost estimates during clinical program/study development
* Coordinate clinical study timelines within a clinical program(s)
* Provide input and operational insight into Clinical Study Concepts (CSC)
* Responsible for development and implementation of operational strategy, driving early study planning budget and timelines from Clinical Study Concept through Final Protocol Review of plans and provision of clinical operations expertise during protocol design, feasibility, study start up, and conduct phases of studies
* Evaluate consistency within the program and develop standard processes within CTM
* Lead all aspects of clinical study budgets within a program: ensure review, presentation, and approval of initial study budget and manage the budget through the lifecycle of the program by communicating changes to TA Operations Leader, as appropriate
Requirements:
* Advanced interpersonal & leadership skills
* Ability to provide operational strategic direction and guidance for clinical programs
* Applies sophisticated technical knowledge to solve highly complex issues
* An understanding of relevant industry trends
* Strong analytical skills with a data-driven approach to planning, executing, and problem-solving
* Advanced interpersonal 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 across a wide range of senior partners
* Budget management expertise and strong financial competence
* Consistent track record of building, leading, and developing productive teams and collaborations
* Expert project management skills, cross-functional engagement, and organizational skills
Candidate Requirements:
* Bachelor's degree
* Minimum of 12 years relevant pharmaceutical industry experience
* 8 years within Clinical Trial Management
* Experience with early phase clinical trials is highly preferred