Associate Director, Therapeutic Area Operations & Project Management

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 Medical Affairs TA Operations & Project Management (TOPM) will provide project management support to the Therapeutic Area (TA) Heads and Medical Directors within Immunology Medical Affairs (MA). The incumbent will also help drive strategic & tactical planning, budget preparation/management/forecasting/accrual management (working closely with Finance), drive project team meetings and prepare minutes, manage ad board preparation & execution, and other operational project needs. Additionally, the TOPM will drive process improvement initiatives as needed. Ensures optimal execution medical affairs activities with our internal and alliance cross functional teams. From time-to-time, the incumbent may also support priority projects for the other Medical Directors within other TA areas within Medical Affairs department. Provides support and backup to management as needed.

Job Duties:
Overall responsibility and related expectations:

• Support Medical Directors with organization and driving execution of Global and US Medical Affairs tactics as defined in the medical plan as agreed and defined with TA Head and Head of Medical Affairs Planning & Operations.
  • Facilitates the creation of the Medical Affairs Strategic and Tactical PlansConducts kickoff, submission core team, and line function meetings
  • Utilizes these plans to track progress vs. plan
  • Facilitates the resolution of timeline issues
  • Provides guidance on good documentation and review/submission practices
• Align with TA Head and Head of Medical Affairs Planning & Operations to ensure optimal utilization of where Project Management activities are needed and ensuring strategic alignment.
• Manage operational and project related budgets for Immunology working closely with Finance and Medical Affairs leaders.
• Provides project-related support of medical affairs activities/projects. This includes but is not limited to all process-related aspects to implementation and execution of Advisory Boards, expert consultations, and management of outside vendors.
• Ensures complaint execution of medical affairs activities. Assists with reviewing and developing departmental procedural documents in accordance with Agency regulations and guidance.
• Provides guidance to other PMO associates with project management activities, issue resolution and other operational activities.
• Provides support to Head of Planning & Operations and Head of Medical Affairs on development and management of departmental metrics and oversee/lead special projects as needed.
• Ensures well-aligned and effective collaboration between Regeneron and a business partner's Medical Affairs organization as well as the relevant US and global franchise teams.
• Assists with internal audit preparation as needed.
• Identifies and communicates business process enhancement needs or technical issues to management and Global Development Systems
• Prepare and manage quarterly departmental metrics and other reports (i.e. Goals and Achievements) for Medical Affairs.

Managerial responsibilities and related expectations:

• Identifies with and actively communicates/applies company values on a consistent basis.
• Demonstrates Core Competencies as defined for Regeneron managers on consistent basis.
• Works in a goal/objective oriented manner within formalized process to plan and execute annual goals in alignment with the corporate annual goals and core business strategy.
• Takes matrix leadership role and/or participates as active member on cross functional teams. Leads a multifunctional team with line accountability to functional disciplines. Ensures teams conduct activities with appropriate sense of urgency.
• Demonstrates excellent people management skills, as well as collaborative efforts with relevant stakeholders within and outside REGENERON.
• Accountable for managing resources within annual Medical Affairs project budgets and managing related expenses and assists Head of Medical Affairs and Head of Planning & Operations with departmental-wide budget planning and forecasting.

Knowledge and Specialized Skills:

• Demonstrates an analytical approach to problem solving and 'evidence-based decision making'.
• Effectively interacts with and collaborates at all levels in the organization, including effective interface at the senior management level.
• Demonstrates strong interpersonal, verbal and written communication skills. Ability to form strong and constructive internal as well as external professional relationships.
• Demonstrates ability to present complex (medical) information to others effectively.
• Able to take an active leadership role and guide cross-functional teams towards the desired outcomes.
• Possesses a desire to 'jump in' and collaborate with cross-functional team in preparation for the first anticipated product launch for the Company; desire to participate in supporting a product launch at an important time for the organization and willingness to 'go the extra mile'.
• Demonstrates a strong ability and desire to collaborate with the commercial/marketing organization in an appropriate manner to ensure commercial strategy, plan and execution incorporate medical input and direction. Ensure that all medical affairs activities in support of the product adhere to all relevant industry regulations and guidelines, such as OIG and The Company's Code of Business Conduct and Ethics.

Requirements:

Education and experience

• Bachelor's Degree with 7+ years working in healthcare/pharmaceutical/biotechnology field.

Skills

• Active working experience in the healthcare/pharmaceutical/biotechnology field (either in academic or industry setting) with working knowledge of drug development.
• Requires strong knowledge of applicable regulatory agency regulations, guidelines and/or specifications (eg. FDA, EMA, ICH).
• Ability to initiate and lead large, cross-function projects and see it through to completion.
• Experience with Early Phase assets a desirable plus.
• Excellent communication and organizational skills.
• Demonstrated project management skills.
• Self-motivated.
• Able to work in a flexible, dynamic environment.

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.