Job Description
This role is a hybrid position that requires a minimum of 3 days on-site in Basking Ridge, NJ or Armonk, NY. Remote work is not an option for this role.
Program Operations Leader (POL) Role and Responsibilities
* Leverage advanced interpersonal and leadership skills to lead and implement the operational strategy for delivery of one or more complex programs in Clinical Trial Management (CTM).
* 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).
* Lead line management of clinical trial management staff, including recruitment, development, coaching, mentoring, and performance management.
* Collaborate with senior-level management, external vendors, collaboration partners, and clinical study personnel to drive functional strategy in partnership with Functional leadership.
Typical Day Activities
* Maintain an overview of clinical program(s) status and issues, proactively communicating 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).
* Develop and implement operational strategy, driving early study planning, budget, and timelines from Clinical Study Concept through Final Protocol.
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.
About Us
We are an inclusive and diverse culture that provides comprehensive benefits, which often include health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.