Director, Clinical PV Operations

Location
Tarrytown, New York
Posted
Apr 19, 2018
Ref
11786BR
Required Education
Other
Position Type
Full time
Position Summary

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.

Summary:
The Director, PV Planning is responsible for managing the PV Planning function and its deliverables, including staff management and escalation to Head of PV. Effectively collaborates with other PV functions to ensure high quality and timely deliverables to support cross-functional goals for both development and commercial products. Demonstrates in-depth understanding of applicable regulations and ability to execute effectively across functions and organizations.

Responsibilities:
• Provides direction and guidance to the PV Planning function to ensure streamlined and efficient process, and fulfillment of support needed from other PV functions as well as other Regeneron functions.
• Maintains oversight of PV Planning's deliverables, including but not limited to Safety Management Plans and study CRO metics.
• Manages staffing and workload to ensure on-time completion of deliverables.
• Exercises judgement to ensure timely escalation and resolution of issues with study CROs to Regeneron management
• Maintains oversight of PV Planning's collaboration with PV Case Management to set up study-specific conventions for case processing, queries, site training, etc.
• Maintains oversight of PV Planning's collaboration with other Regeneron functions who require PV support, such as IIS, patient support programs, etc.
• Effectively manages staff and workload to ensure overall compliance with PV standards
• Identifies and leads process improvement activities whether internal or external to PV or Regeneron, including vendors or License Partners.
• Authors new and updates to SOPs and Working Instructions, and conduct related training.
• Acts as PV SME for both internal and external porjets to support both development and commercial projects
• Leads continuous improvement/quality system initiatives through evaluation, development and roll out of process efficiencies applicable to all PV Planning deliverables whether internal or external to the department.
• Manages personnel, which includes but is not limited to management of job performance, career development and training.

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Requirements:
• Pharmacy, nursing or degree in healthcare and/or life sciences required, advanced degree preferred.
Previous Pharmacovigilance/Drug Safety experience in pharmaceutical / biotech industry required; typically with 12 + years of Pharmacovigilance/Drug Safety experience.
• Well informed on relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments required.
• Excellent communication skills, both written and verbal
• Excellent time management and priority setting to ensure on-time and high quality deliverables
• Exemplary standards on integrity, accountability, and overall work ethics.
• Extensive experience with managing direct reports on complex projects.
• Demonstrated success in working on cross-functional teams in a leadership role.

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: 11786BR