Clinical Development Lead, Transplant Expansion / New Indications

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. What You’ll Do: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 teamsServe as subject matter expert on the safety reviews of our transplant programsPresent 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. Who You Are: You are a motivated leader with a passion for scientific innovation, particularly in the field of transplant medicine. You possess a strong sense of purpose and are driven by the potential to make a real-world impact on patient care. Your experience in the pharmaceutical or biotech industry has honed your expertise in clinical research and drug development. You thrive in cross-functional teams and are adept at building consensus among diverse stakeholders. Your agility in learning and strategic thinking enables you to navigate complex environments and optimize development strategies. You are a clear communicator, able to articulate scientific concepts effectively to various audiences. Your collaborative nature and ability to establish relationships with key opinion leaders make you stand out as a candidate for this role. This position ideally is based in close proximity to our West Coast Hub team located in South San Francisco, CA, however for the right combination of experience and leadership we are open to hiring remote-US based.