Clinical Development Lead, Transplant Expansion / New Indications

Biogen; South San Francisco (CA); Hybrid; USD 80,000 - 100,000; Full time

Job summary

An established industry player is seeking a Clinical Development Lead to transform patient care in transplant medicine. This pivotal role involves driving innovative drug development strategies and collaborating with diverse stakeholders to enhance clinical outcomes. You will leverage your extensive experience in clinical research and drug development to influence decision-making and ensure regulatory success. If you are passionate about making a real-world impact and thrive in a collaborative environment, this opportunity offers a chance to advance your career while contributing to groundbreaking clinical programs aimed at improving patient lives worldwide.

Qualifications

• 5-7+ years of clinical drug development experience in pharma/biotech.
• Strong background in clinical research, particularly in transplant medicine.

Responsibilities

• Drive complex projects from strategy to value realization.
• Design clinical studies and interpret study data for drug development.
• Support regulatory filings and collaborate with cross-functional teams.

Skills

Clinical drug development

Leadership

Interpersonal skills

Problem-solving

Analytical capabilities

Education

MD degree with board certification in nephrology or immunology

Job description

Job Description

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 teams.
• Serve as subject matter expert on the safety reviews of our transplant programs.
• Present 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.

Required Skills:

• MD degree with board certification in nephrology, immunology, or a similar field.
• Five to seven (5-7+) years of clinical drug development experience inside pharma/biotech, with a strong background in clinical research. Ideal drug development experience in organ transplant, nephrology, and/or immuno-inflammatory indications.
• Broad knowledge of basic, translational, and clinical science, particularly in transplant and immunological or rare disease areas.
• Demonstrated leadership abilities and effectiveness in a team-oriented environment.
• Exceptional interpersonal skills and the ability to maintain relationships with key stakeholders.
• Proven problem-solving, conflict resolution, and analytical capabilities.
• Experience facilitating discussions and driving decisions among cross-functional groups.
• Willingness to travel domestically and internationally, approximately 10-20% of the time.

Preferred Skills:

• Experience with late-stage drug development processes.
• Familiarity with the nuances of rare disease drug development strategies.
• Publication record in peer-reviewed scientific journals.

This role offers the opportunity to advance your career while contributing to cutting-edge clinical development programs that have the potential to improve the lives of patients worldwide. If you are ready to take on this challenge and make a difference, we encourage you to apply.