Manager/Sr. Manager, Global Feasibility
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 Manager, Global Feasibility will utilize high quality operational plans, recruitment plans and feasibility data to help optimize Clinical Study Concepts, Study Protocols and Operational Plans to drive predictable delivery of clinical programs and studies. The Manager, Global Feasiblity will develop internal/external stakeholder engagement platforms in order to identify and maintain key relationships in alignment with Regeneron's clinical development plans.
Essential Functions required for the job. List both technical and managerial requirements if applicable.
• Coordinate country landscape assessments and thecollection of targeted high quality feasibility information in collaboration with Project Management to support early assessment of medical and operational feasibility for conducting clinical trials.
• Utilize country level information and centrally derived data to support study teams in obtaining insights and making data driven decisions to enhance protocol design and ensure optimal placement of studies across different geographies
• Ensure cross-program consistency of operational planning in support of study design decisions and downstream study execution
• Support study level design sessions to ensure key operational strategies and capabilities are factored into strategic decision making
• Develop historical country and site intelligence data to support operational delivery (eg, site capabilities, performance, regulatory landscape, treatment patterns etc)
• Identify and leverage external knowledge of industry best practices, processes and new trends
• Understand local outreach and patient referral pathways in support of global/local operational delivery
• Develop and maintain knowledge of external clinical trial environment and assess developments for impact on study design and execution
• Engage with key opinion leaders to obtain input on proposed study design as required and analyze feedback for incorporation into study design and operational planning decisions
• Use site intelligence and cross-functional input for study-level operational planning in support of validation of country commitment for a study
• Qualified candidate will have a BS in a related discipline; A MS or MBA is highly desirable.
• At least 7 years of relevant industry experience within pharma/biotech, a CRO or consulting is required, with 5 years of functional leadership highly desirable.
• A good understanding of all operational processes required to deliver a clinical development program from first-in-human to post-approval
• Strong understanding and experience in operationalizing clinical development programs in a global setting
• Strong negotiation and relationship management skills
• Knowledge of global regulatory requirements and guidelines for conducting clinical research and safety monitoring / reporting
• Extensive experience in performance metrics (Time, Cost and Quality).
• Ability to translate complex business questions and requirements and develop effective solutions
• Strong business acumen
• Demonstrated effective influencing and negotiating, good interpersonal and leadership skills, a team player
• Self-motivated, works effectively under pressure
• Detail oriented
• Ability to mine data to identify trends
• Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.
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.
Requisition Number: 10255BR