Clinical Development Lead

Summary

Join Biogen's West Coast Hub and become a Clinical Development Lead, focusing on transforming the lives of patients with severe immune-mediated diseases. You will play a key role in expanding the company's Phase 3 trial for antibody-mediated rejection, developing new indications for felzartamab, and accelerating clinical development plans. This position requires collaboration with cross-functional teams, subject matter experts, and regulatory authorities. You will design clinical studies, interpret data, and support regulatory filings. The ideal candidate is a motivated leader with experience in clinical research and drug development within the pharmaceutical or biotech industry. This role offers the opportunity to advance your career while contributing to cutting-edge clinical development programs.

Requirements

• MD degree with board certification in nephrology, immunology, or a similar field
• Five to seven (5-7+) years of clinical drug development experience inside pharma/biotech, with a strong background in clinical research. Ideal drug development experience in organ transplant, nephrology, and/or immuno-inflammatory indications
• Broad knowledge of basic, translational, and clinical science, particularly in transplant and immunological or rare disease areas
• Demonstrated leadership abilities and effectiveness in a team-oriented environment
• Exceptional interpersonal skills and the ability to maintain relationships with key stakeholders
• Proven problem-solving, conflict resolution, and analytical capabilities
• Experience facilitating discussions and driving decisions among cross-functional groups
• Willingness to travel domestically and internationally, approximately 10-20% of the time

Responsibilities

• Represent the Biogen West Coast Hub Development team and influence decision-making in relevant governance and strategic forums
• Identify additional transplant indications for felzartamab, differentiating it from current market competitors
• Build and strengthen relationships with internal and external stakeholders, gathering expert feedback to develop felzartamab life cycle management frameworks
• Employ innovative approaches for rare disease drug development and real-world evidence to expedite development timelines
• Design and implement a robust felzartamab framework, engaging with external stakeholders to identify meaningful efficacy endpoints
• Coordinate with study team members to develop well-structured protocols for additional indications
• Support regulatory filings, addressing inquiries efficiently and effectively
• Support internal and external clinical translational studies in close collaboration with Biomarker and Immunology Research teams
• Serve as subject matter expert on the safety reviews of our transplant programs
• Present at investigator meetings, ensuring global study execution consistency
• Contribute to data analysis, scenario planning, and communicate study readouts with clarity
• Integrate scientific rationale with regulatory, payor requirements, and commercial goals for each clinical development plan
• Present compelling data at international meetings and publish findings in respected scientific journals

Preferred Qualifications

• Experience with late-stage drug development processes
• Familiarity with the nuances of rare disease drug development strategies
• Publication record in peer-reviewed scientific journals

Benefits

• 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