About This Role
Biogen is seeking an experienced Senior Director, Global Access Mechanisms to join the Worldwide Medical Organization. As the Head of Global Access Mechanisms, you will oversee the strategy, policies, and procedures governing our global access mechanism programs, including Post Trial Access, Early Access, Charged Managed Access, Compassionate Use, and Humanitarian Access. Leading a small, high-performing team, you will be accountable for operational execution of these programs and managing the executive Global Access Mechanism Governance Committee, Chaired by the Chief Medical Officer. In this role, you will collaborate cross-functionally with Global Medical, Regional and Local Medical Leadership, Worldwide Medical Information, Commercial, Clinical Development, Legal, Compliance, Regulatory, Manufacturing, Corporate Affairs, Finance, Value & Access to ensure our programs meet ethical standards and align with Biogen’s policies.
Your work will be instrumental in enabling patients with serious or life-threatening conditions to have ethical, timely and compliant access to investigational or unapproved therapies and approved therapies outside of clinical trials, making a direct impact on patient care worldwide.
What You’ll Do
Lead and execute the company’s global access mechanisms policy and strategy in alignment with long-term company goals.
Develop, implement, and continuously improve the global access mechanisms strategic framework in partnership with the Global Access Mechanism Governance Committee.
Identify opportunities to optimize and expand access mechanism pathways across the product lifecycle, incorporating industry-leading practices.
Represent the company in global forums, conferences, and consortia related to expanded access and ethical drug availability.
Design, launch, and manage access mechanism programs, ensuring compliance with global and local regulatory frameworks and internal standards.
Develop and oversee policies, standard operating procedures, and training curriculums for the compliant execution of access mechanism programs.
Lead cross-functional initiatives to communicate Biogen’s position and philosophy on access mechanism programs to external stakeholders, including patients, caregivers, and advocacy groups.
Build, lead, and mentor a high-performing team responsible for access mechanism program execution and operations.
Foster a culture of excellence, compliance, and patient-centricity within the team and broader medical organization.
Drive operational excellence and ensure flawless execution of access mechanism programs globally.
Who You Are
You have a deep understanding of access mechanism programs, including ethical considerations, regulatory requirements worldwide and operational logistics, along with a proven track record of cross-functional leadership in the biopharmaceutical industry. You are comfortable with ambiguity and can assimilate new knowledge and standards quickly. Additionally, you have a passion for patient care, equity, and ethical medical practice.
Qualifications
Required Skills
BSc/MSc in a scientific/clinical/medical field
10 - 15 years’ experience in the biotechnology or pharmaceutical industry, working in a GxP environment, with at least 5 years’ experience leading Access Mechanism Programs, Complex Program Management, Business Process, Clinical Research Operations experience, or Operations Management
Effective communicator and facilitator with all levels of the organization, including Executive Leadership and clinical, regulatory, and commercial audiences; ability to quickly forge partnerships with and effectively influence a large and diverse set of stakeholders
Knowledge of ICH/GCP, global regulatory guidelines/directives, and drug development and clinical research processes, with scientific learning agility to quickly develop a sound working knowledge of new therapeutic areas
Deep knowledge of global regulatory and ethical frameworks governing patient access to investigational drugs
Experience establishing Strategic Direction, Driving Execution, Compelling Communications and a Global-Local perspective, and Cross-Functional Stakeholder Management, Team Management in a Matrixed Environment
Quarterly Travel to Cambridge/Baar Offices
Preferred Skills
Experience in Clinical Operations
Experience in project/portfolio management and/or finance
Diverse working experience, including in/at affiliate and global levels, while interfacing with non-Medical functions and leading larger, cross-functional teams
Additional Information
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
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