Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.
The Senior Clinical Study Lead (CSL) is accountable for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study close out. The Senior CSL is accountable for the study timelines, study budget, and ensuring study conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP. This role applies to internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs) and the balance of direct leadership versus oversight will vary accordingly. Contributes and drives ongoing process improvement initiatives. Responsible for direct line management responsibilities.
Leads the cross-functional study team responsible for clinical study delivery and is the primary point of contact of leadership and oversight(as required) for the assigned study
Provides operational input into protocol development
Oversees and provides input to the development of study specific documentation including but not limited to: case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc.
Oversees set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc.
Ensures compliance with the clinical trial registry requirements
Identifies outsourcing needs of the study and leads and oversees engagement, contracting and management of required vendors
Provides input into baseline budget development and management
Provides input into baseline timeline development and management
Leads risk assessment and identifies risk mitigation strategies at the study level
Leads the feasibility assessment to select relevant regions and countries for the study
Oversees/conducts site evaluation and selection
Leads investigator meeting preparation and execution
Monitors progress for site activation and monitoring visits and acts on any deviations from plan
Leads the development of and oversees implementation of patient recruitment and retention strategies and acts on any deviations from plan
Monitors data entry and query resolution and acts on any deviations from agreed metrics
Ensures accurate budget management and scope changes for internal and external studies
Oversees and provides input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliation
Escalates issues related to study conduct, quality, timelines or budget to Program Operations Leader (POL) and other stakeholders and develops and implements appropriate actions to address issues
Oversees the execution of the clinical study against planned timelines, deliverables and budget
Oversees data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites
Oversees and ensures the CROs and Third Party Vendors are in alignment and are delivering per the scope of work
Ensure clinical project audit and inspection readiness through the study lifecycle
Supports internal audit and external inspection activities and contributes to CAPAs as required
Manages and oversees study close-out activities including but not limited to database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability
Contributes to clinical study report writing and review
Facilitates and contributes to study level lessons learned
Assigns tasks to Clinical Study Management staff and supports their deliverables
Recommends and participates in cross-functional and departmental process improvement initiatives
Responsible for identification of innovative approaches to clinical study execution including global considerations and continuous improvement of CTM SOPs
May be assigned unmasked tasks for studies, which may include but is not limited to, assisting with masked investigational product, set up and management of unmasked trial master file, review of unmasked data in the electronic data capture system, point of contact for IVRS issues, and support oversight of unmasked clinical monitoring
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
Demonstrated interpersonal & leadership skills
Ability to understand and implement the strategic direction and guidance for respective clinical studies
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
An awareness of relevant industry trends
Ability to build productive teams and collaborations
Demonstrated vendor management experience
Technical proficiency in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC
Experience in global clinical trial operations including experience developing protocols and key study documents
Knowledge of ICH/GCP and regulatory guidelines/directives
Effective project management skills, cross-functional team leadership and organizational skills
Line management experience
Bachelor's degree and minimum of 8 years relevant industry experience. advanced degrees may be considered in lieu of relevant experience.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.
To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.","title":"Senior Clinical Study Lead - Oncology