Clinical Development Lead, Transplantation

Biogen's West Coast Hub is seeking a highly motivated and experienced Clinical Development Lead, Transplantation to support clinical development activities for our organ transplant portfolio. The successful candidate will support the development of our novel therapeutic candidates in late-stage studies as a key member of the clinical development team. You will primarily be involved in activities associated with design, execution, monitoring, data interpretation, and reporting of clinical studies evaluating novel therapies across organ transplantation.

The role involves extensive matrix interactions with colleagues from various disciplines to ensure the successful execution of clinical development plans and regulatory filings. Additional responsibilities involve managing external collaborations, gaining comprehensive knowledge of the literature related to the product(s) in development, supporting Regulatory interactions, and supporting Medical Affairs and Commercial colleagues.

Who You Are

You have a strong foundation in clinical research and transplantation medicine seeking to apply your expertise to clinical development. You are passionate about advancing therapies that improve transplant outcomes, skilled in communicating complex clinical insights, and thrive in a highly collaborative, cross-functional environment. You are curious and creative with a passion for improving the lives of patients.

What You Will Do

• 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.

• 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