Sr Clinical Development Lead, Transplant Expansion / New Indications

Role Summary

Senior Clinical Development Lead for transplant expansion / new indications within the Biogen West Coast Hub. Drives strategic clinical development plans for new transplant indications, accelerates timelines, and collaborates cross-functionally with internal teams, external stakeholders, patients, scientists, and regulatory authorities to increase technical and regulatory success.

Responsibilities

• Represent the Biogen West Coast Hub Development team and influence decision-making in governance and strategic forums. Identify additional transplant indications for the lead asset, differentiating it from competitors.
• Build and strengthen relationships with internal and external stakeholders to develop life cycle management frameworks.
• Apply innovative approaches for rare disease drug development and real-world evidence to expedite timelines.
• Coordinate with study team members to develop well-structured protocols for additional indications.
• Serve as subject matter expert on safety reviews of transplant programs; support regulatory filings and address inquiries efficiently.
• Support internal and external clinical translational studies in collaboration with Biomarker and Immunology Research teams.
• Present at investigator meetings, ensure global study execution consistency, present data at international meetings, and publish findings in scientific journals.
• Contribute to data analysis, scenario planning, and communicate study readouts clearly.
• Integrate scientific rationale with regulatory, payor requirements, and commercial goals for each clinical development plan.

Qualifications

• MD and/or PhD required, with board certification in nephrology, immunology, or similar field.
• At least ten years of relevant experience in pharmaceutical/biotech industry and clinical research; essential clinical drug development experience, including late-stage development, with preference for transplant, nephrology, or immuno-inflammatory indications.
• Extensive knowledge of basic, translational, and clinical science; broad understanding of transplant, immunological, and/or rare disease areas.
• Dynamic leadership and ability to perform in an adaptive, cross-functional environment.
• Strong scientific and clinical acumen with learning agility and ability to optimize development strategies.
• Excellent interpersonal skills to establish and maintain relationships with key opinion leaders, investigators, and internal stakeholders.
• Strong problem-solving, conflict resolution, and analytical skills.
• Ability to facilitate cross-functional discussions and drive decisions on complex issues.
• Ability to travel domestically and internationally, approximately 10-20% of the time.

Skills

• Clinical research leadership
• Strategic development planning
• Regulatory and clinical pharmacology understanding
• Translational science and biomarker collaboration
• Data analysis and readout communication
• Cross-functional collaboration and stakeholder management

Education

• MD and/or PhD required; board certification in nephrology, immunology, or related field.

Additional Requirements

• Willingness to travel up to 20% domestically and internationally.