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 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. Activities include leading long term extension studies for current transplant programs and developing a framework for new indications. This requires 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. 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 Youll Do:

• Represent the Biogen West Coast Hub Development team and influence decision-making in relevant governance and strategic forums. Identify additional transplant indications for our lead asset differentiating it from current market competitors.
• Build and strengthen relationships with internal and external stakeholders gathering expert feedback to develop life cycle management frameworks.
• Employ innovative approaches for rare disease drug development and real-world evidence to expedite development timelines.
• Coordinate with study team members to develop well-structured protocols for additional indications.
• Serve as subject matter expert on the safety reviews of our transplant programs. Support regulatory filings addressing inquiries efficiently and effectively.
• Support internal and external clinical translational studies in close collaboration with Biomarker and Immunology Research teams.
• Present at investigator meetings ensuring global study execution consistency. Present compelling data at international meetings and publish findings in respected scientific journals.
• 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.

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.

Qualifications

The ideal candidate will have the following mix of professional and personal characteristics:

• MD and/or PhD/PharmD degree required with specialization in solid organ transplant (kidney heart liver or similar). Significant experience in transplant clinical research is required
• Three (3) or more years of relevant experience within pharmaceutical/biotech industry is required. Clinical drug development experience is essential including experience in late-stage drug development with a preference for experience in transplant and/or immuno-inflammatory indications
• Demonstrated dynamic leadership and team-oriented skills as well as perform effectively in an adaptive environment
• Scientifically and clinically astute with strong learning agility and demonstrated ability to optimize development strategies and advance
• Strong interpersonal skills with the ability to establish and maintain relationships with key opinion leaders clinical investigators and internal stakeholders through a highly collaborative approach
• Strong problem-solving conflict resolution and analytical skills
• Ability to facilitate discussions among cross-functional groups and drive decisions on complex issues
• Ability to travel domestically and internationally approximately 10-20% of the time

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Additional Information