Full-Time Clinical Development Lead, Transplant Expansion

About This Role: The Biogen West Coast Hub (WCH) is focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies. We are seeking a highly motivated and experienced Clinical Development Lead to expand beyond a Phase 3 trial. The candidate will embed strategic principles into all aspects of Clinical Development, ensuring plans increase the probability of technical and regulatory success. Activities include developing frameworks for new indications, assessing regulatory policies, designing clinical studies, and interpreting study data.

What You’ll Do:

• Represent the Biogen WCH Development team and influence decisions.
• Identify transplant indications for felzartamab.
• Build relationships with internal and external stakeholders.
• Employ innovative approaches for rare disease drug development.
• Design and implement a robust felzartamab framework.
• Coordinate with study teams to develop protocols.
• Support regulatory filings.
• Support clinical translational studies.
• Serve as subject matter expert on safety reviews.
• Present at investigator meetings.
• Contribute to data analysis and study readouts.
• Integrate scientific rationale with regulatory requirements.
• Present data at international meetings and publish findings.

Who You Are:

• Motivated leader with a passion for scientific innovation in transplant medicine.
• Experienced in pharmaceutical or biotech industry clinical research.
• Thrives in cross-functional teams and builds consensus.
• Clear communicator able to articulate scientific concepts.
• Collaborative and able to establish relationships.

Required Skills:

• MD degree with board certification in nephrology, immunology, or a similar field.
• 5-7+ years clinical drug development experience in pharma/biotech.
• Strong background in clinical research.
• Experience in organ transplant, nephrology, and/or immuno-inflammatory indications.
• Broad knowledge of basic, translational, and clinical science.
• Demonstrated leadership in a team-oriented environment.
• Exceptional interpersonal skills.
• Proven problem-solving and analytical capabilities.
• Experience facilitating discussions.
• Willingness to travel.

Preferred Skills:

• Experience with late-stage drug development.
• Familiarity with rare disease drug development.
• Publication record in peer-reviewed scientific journals.

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