Senior Manager, Medical Operations

Job Description

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.
Job Summary:
The Senior Manager, Medical Operations will be responsible for all process–related aspects of multiple projects/programs such as the Investigator-Initiated (IIS) Studies Program, Collaboration Studies, Registries, Compassionate Use Programs, and Phase 4 studies led by Medical Affairs, while ensuring compliance standards are met. Based on team assigned, this role may include supervision of staff. The Senior Manager, Medical Operations will also actively manage Alliance Phase 4 activities for partnered molecules, interacting directly with Alliance Company and internal reviews and tracking. Additionally, the incumbent will support MA projects, as requested.
Job Responsibilities:
Program management activities: Has responsibility for multiple projects/program(s) with minimal direction: IIS, Pre-Clinical Collaborations, Sample Analysis Studies, Collaboration studies, Compassionate Use, Data Transparency, Ph4 Registries, RWE HEOR Studies, and Company Sponsored Ph4 Interventional Studies
Proposal Management:

• Ensures all proposals are complete, aligned with Areas of Interest, are reviewed by the governing body for specific study types, and all relevant decisions are obtained prior to moving approved studies forward. This may include agreement of activities from, Product Team, Alliance Partner, Strategic Level alignment and Senior Management endorsement when appropriate, and applies to both original proposals and amendments
• Meetings & Committees: Facilitates Medical Affairs driven meetings & committees, sets agenda, drives goals, documents meeting outcomes, and ensures follow-up for any action items determined, holding team members accountable for any assigned deliverables. This may include scientific meetings with external Investigators, as well as with the Field Medical Team

Budget Management:

• Responsible for obtaining internal approval of associated study budget, ensuring Fair Market Value analysis on line items has been completed, conducts budget negotiations when needed, and initiates requisition process
• Manages ongoing Purchase Order’s (PO) including: validation and documentation of milestone completed, invoicing, accruals, projections, yearly trends and annualized budget planning, and reporting to Accounting & Finance
• Processes budget changes and reforecasts, ensuring transparent communication with internal stakeholders
  Reconciles budget on regular interval schedule, and ensures all payments processed prior to PO closure

Drug Supply:

• Proactive drug campaign planning for various programs in advance of study initiation, including any specific packaging and labeling requirements needed for individual studies/programs, country specific requirements, and ensuring Import Licenses are obtained and QPV release occurs when necessary
• Ensures timely drug shipments and resupply to sites, and clear communication occurs regarding expiry and quarantines, temperature excursions processing, and ensures drug destruction occurs for any unusable product
• Metrics & Reporting: Responsible for ongoing analyses, tracking and reporting of study progress versus timelines committed by investigator, data delivery and program impact, and other related metrics in support of program activities

Contracting:

• Coordinates contracting with Legal, Procurement, and Sites, ensuring contract terms are correct and inclusive of any required special contractual agreements
• Ensures Patent reviews and Due Diligence Process are completed (OIG exclusion list, FDA debarment list, Anti-Bribery-Anti-Corruption background checks)
• Vendor Management: Manage vendors from RFP and vendor selection thru contracting and study implementation. Ensure study deliverables from the vendor(s) are met as outlined in the SOW
• Essential Documents: Ensures collection, tracking and archiving of all relevant documents, such as IND cross-reference letters, IRB approvals and renewals, IND acknowledgment letters

Pharmacovigilance Compliance:

• Ensures timely receipt, tracking and distribution of SAEs, Investigator Alert Letters (IAL), and reconciliations.
• Periodically runs compliance reports to ensure timelines are within acceptable range

Publications:

• Ensures internal publications review, consolidates comments, receipt by Investigator, and documents actions taken

Antibody/Samples:

• For studies utilizing antibodies in a Pre-Clinical model, collecting PK, ADA, or genetics samples, or for studies providing clinical samples, ensures timely shipments, reconciliations, analysis and data delivery when appropriate

Systems Management (Utilizes appropriate systems to contribute to cross-functional communication, planning and transparency, including but not limited to):

• Ensures data capture into corporate project software, supports the entry of submissions and data management within the corporate portal, and QC’s SharePoint document storage for completeness and audit readiness.
  Facilitates and provides support of electronic proposal submissions and review process
• Running of reports in preparation for financial and/or study status update meetings, including QlikSense, QlikView, SharePoint, Oracle and utilizing corporate portal

Process:

• Adheres to all relevant processes, training, and SOPS to ensure consistency, efficiency, and compliance
• Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions
• Continued process improvements to ensure consistency, efficiency, and compliance

Organizational goals:

• Development of objectives in order to quantify success and attainment of goals
• Ensures optimal structure, procedures, and adequate resources supporting growth of multiple programs or product
• Knows when to escalate issues, and involve senior levels of management to obtain adequate resolution

Alliance Management:

• Ensures optimal alignment with both Alliance and internal stakeholders in support of project/program, while driving activities forward, and communicating potential risks and solutions transparently

People Management (if applicable):

• Management of direct reports, trainings as deemed necessary, workload distribution for optimal effectiveness, performance against defined goals and expectations, and support for individual growth
• Uses discretion when determining who (if anyone) to assign specific team deliverables to. Guidance is typically needed by direct reports for success

Note: Due to the varying number of projects that will need to be supported at different times there may be a wide range of time allocated to activities, allowing for unique involvement based on prior work experience and skills of incumbent. For a given year and as part of the Annual Goals planning, the type/scope of projects and weight will be clearly defined.
Job Requirements:

• Requires BA/BS in a related field
• 12+ years of ‘progressive’ industry/relevant professional experience
• 7+ years active work experience in area of clinical research and/or regulatory and//or field-based function in pharmaceutical and/or biotech company(ies) and experience or courses pertaining to clinical research and/or MA functional areas
• Ideally, the incumbent will have a science background with active experience in aforementioned areas, ideally in the therapeutic areas of (specify TA area here) and/or antibody research
• Incumbent must have track record of working well in a dynamic environment, must be self-motivated, able to work with a limited amount of supervision after the initial on-boarding period and enjoy working with different stakeholders (clinical, pre-clinical, commercial, external customers)
  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.