Director, Medical Affairs Project Management & Operations

As a Director, Medical Affairs TA Operations & Project Management (TOPM) you will provide project management support to the Global Medical Affairs Head and Medical Directors.
Primary responsibilities include leading our strategic planning, budget preparation, management, forecasting, accrual management (in collaboration with Finance). You will function as the Chief Operations Officer (COO) for the Franchise and/or HEOR function.

In addition, the TOPM is responsible for the planning & management of project team meetings, adboard preparation & execution, and other operational business needs. As part of our Medical Affairs Operations team you will drive process improvement initiatives as needed. Ensures efficient execution of the Medical Affairs Product Plans (MPPs) and support cross-functional collaboration with our internal and external alliance partners.

A typical day may include:

• Supports Global Medical Affairs Head (GMA Lead) and Medical Directors within the Franchise leading execution of Global and US Medical Affairs tactics as defined in the Medical Product Plans.
• Translating project deliverables and strategic program imperatives resulting in seamless execution
• Collaborating with GMA Lead and/or HEOR Head on priorities and ensure optimal execution.
• Ensuring compliant execution of activities and assists with the review and development of departmental procedural documents in accordance with Agency regulations and guidance.
• Oversight to PMO associates for project management activities, issue resolution and other activities.
• Supporting the GMA Head and/or Head of Medical Affairs on the development and management of departmental metrics and oversees/leads special projects as needed.

Managerial expectations

• Accountable for resources within annual Medical Affairs project budgets and related expenses. Assists Head of Medical Affairs and Head of department with departmental-wide budget planning and forecasting.

• Direct or indirect responsibilities managing and/or mentoring other PMO staff.
• Demonstrates Core Proficiencies and ability to work independently demonstrating soft skills and technical skills to provide seamless execution on a consistent basis
• Takes matrix leadership role and/or participates as active member on cross functional teams. Leads a multifunctional team with line accountability to functional subject areas. Ensures teams conduct activities with appropriate timeliness.

This may be for you if you can:

• Demonstrates an analytical approach to problem solving and 'evidence-based decision making'.
• Interacts and collaborates at all levels, including effective interfacing at the senior management level.
• Demonstrates ability to translate & present complex (scientific) information to others effectively.
• Demonstrates a strong ability and desire to collaborate with the commercial/marketing organization to ensure commercial strategy, plan and execution incorporate medical input and direction.
• Operate in a goal/objective oriented manner within formalized process to plan and execute goals aligned with corporate goals and core business strategy.

To be considered for this a Bachelor's Degree (Advanced degree desirable) with 12 + years of active working experience in the healthcare/pharmaceutical/biotechnology field (either in academic or industry setting) with solid understanding of drug development. PMP certification is a preferred. 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 plus.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.