Clinical Development Lead, Transplant Expansion / New Indications

Position Overview

• Location Type: Remote
• Employment Type: Full-time
• Job Type: Clinical Development Lead

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 with outsized clinical impact, faster. To accomplish this for transplant recipients, we are seeking a highly motivated and experienced Clinical Development Lead for our expansion beyond our ongoing Phase 3 trial in late antibody-mediated rejection. The successful hire candidate will embed strategic principles into all aspects of Clinical Development, ensuring plans increase the probability of technical and regulatory success. Activities include developing a framework for new indications, assessing regulatory and relevant policies that could accelerate drug development timelines, designing clinical studies, and interpreting study data while fully collaborating and leveraging the synergies of our ongoing pivotal program. The successful candidate will initiate and drive complex projects from strategy to value realization, including creating a framework for accelerating clinical development plans for each new transplant indication in our lead asset, felzartamab. This requires collaboration with cross-functional teams, subject matter experts, and other relevant stakeholders internally and externally, including the patient and scientific community, as well as global regulatory authorities.

Requirements

• Highly motivated and experienced Clinical Development Lead
• Passion for developing novel targeted therapies
• Strong leadership skills
• Experience in rare disease drug development
• Ability to collaborate with cross-functional teams and external stakeholders

Responsibilities

• Represent the Biogen West Coast Hub Development team and influence decision-making.
• Identify additional transplant indications for felzartamab.
• Build and strengthen relationships with internal and external stakeholders.
• Employ innovative approaches for rare disease drug development and real-world evidence.
• Design and implement a robust felzartamab framework.
• Coordinate with study team members to develop clinical study protocols.
• Support regulatory filings and address inquiries efficiently.
• Support internal and external clinical translational studies.
• Serve as subject matter expert on the safety reviews of transplant programs.
• Present at investigator meetings and ensure global study execution consistency.
• Contribute to data analysis, scenario planning, and communicate study readouts.
• Integrate scientific rationale with regulatory, payor requirements, and commercial goals.
• Present compelling data at international meetings and publish findings in scientific journals.

Company Information

• Company: Biogen (WCH)
• Focus: Developing novel targeted therapies for severe immune-mediated diseases, particularly for transplant recipients.
• Lead Asset: felzartamab

Application Instructions

• Specific application instructions were not provided in the original job description.