- Lead medical and scientific oversight of organ transplantation clinical trials, including protocol design, study monitoring, safety review, and data analysis ensuring alignment with strategic objectives and timelines while adhering to GCP and regulatory requirements
- Provide clinical expertise in nephrology and transplantation
- Communicate with investigators to address study conduct and enrollment at study sites
- Collaborate with Clinical Operations in trial setup, site engagement, recruitment, retention strategies, closeout, and reporting
- Partner with data management and biostatistics in data review, query resolution, and ensuring high-quality datasets for regulatory filings
- Prepare and contribute to clinical study reports, regulatory submissions, and responses to Ethics Committees and Health Authorities
- Provide clinical leadership to cross-functional project teams with peers from clinical operations, biometrics, clinical pharmacology, biomarkers, regulatory affairs, medical writing, and others
- Establish and maintain trusted collaborations with key opinion leaders and clinical investigators in the transplantation field and disease areas related to clinical development programs
- Ensure compliance with regulatory requirements and guidelines
- Represent Biogen externally at scientific conferences, investigator meetings, and other industry events
- US board-certified transplant nephrologist (MD or equivalent)
- 3+ years of clinical development experience in the pharmaceutical or biotechnology industry or equivalent
- Team player with significant clinical experience managing patients with organ transplants
- Knowledge of clinical trial design and execution, patient recruitment, and outcomes in transplant populations
- Understanding of regulatory requirements for drug development, including experience leading interactions with global regulatory agencies
- Ability to analyze and communicate complex data from transplant clinical trials
- Excellent interpersonal skills, with the ability to establish and maintain relationships with key opinion leaders, clinical investigators, and internal stakeholders through a highly collaborative approach
- Strong written and verbal communication skills; ability to present clinical insights to leadership and external stakeholders
- Ability to travel domestically and internationally, approximately 30% of the time.
#LI-RD8
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.
Top Skills
Similar Jobs
What you need to know about the Colorado Tech Scene
Key Facts About Colorado Tech
- Number of Tech Workers: 260,000; 8.5% of overall workforce (2024 CompTIA survey)
- Major Tech Employers: Lockheed Martin, Century Link, Comcast, BAE Systems, Level 3
- Key Industries: Software, artificial intelligence, aerospace, e-commerce, fintech, healthtech
- Funding Landscape: $4.9 billion in VC funding in 2024 (Pitchbook)
- Notable Investors: Access Venture Partners, Ridgeline Ventures, Techstars, Blackhorn Ventures
- Research Centers and Universities: Colorado School of Mines, University of Colorado Boulder, University of Denver, Colorado State University, Mesa Laboratory, Space Science Institute, National Center for Atmospheric Research, National Renewable Energy Laboratory, Gottlieb Institute
