Clinical Operations Director
3 hours ago
This role is a hybrid position which requires a minimum 3 days on-site in a designated location. Remote work is not an option for this role.
The Clinical Operations Director will lead and implement the operational strategy for delivery of one or more complex programs in Clinical Trial Management (CTM). This individual is 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 Clinical Operations Director 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 Clinical Operations Director is responsible for line management of clinical trial management staff (including AD POL), and has responsibility for staff recruitment, development, coaching, mentoring and performance management. Plays a key role in driving the functional strategy of Clinical Trial Management in partnership with Functional leadership. The Director is expected to operate with autonomy and high-degree of independence.
Key Responsibilities
- Be 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 partners as requested
- Provides operational insight into feasibility, timeline and cost estimates during clinical program/study development
- Coordinates clinical study timelines within a clinical program(s)
- Provides 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. Ensure consistency within the program and development of standard processes within CTM
- Leads all aspects of 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
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 (i.e., functional area heads)
- 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
This role requires a Bachelor's degree and minimum of 12 years relevant pharmaceutical industry experience, 8 years within Clinical Trial Management. Experience with early phase clinical trials is highly preferred.
Regeneron is 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.
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