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 immunemediated 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 antibodymediated 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 crossfunctional 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 decisionmaking 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 realworld 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 wellstructured 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 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 realworld 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 crossfunctional 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 remoteUS based.

Qualifications :

Required Skills:

• MD degree with board certification in nephrology immunology or a similar field
• Five to seven 57 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 immunoinflammatory 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 teamoriented environment
• Exceptional interpersonal skills and the ability to maintain relationships with key stakeholders.
• Proven problemsolving conflict resolution and analytical capabilities
• Experience facilitating discussions and driving decisions among crossfunctional groups
• Willingness to travel domestically and internationally approximately 1020 of the time

Preferred Skills:

• Experience with latestage drug development processes
• Familiarity with the nuances of rare disease drug development strategies
• Publication record in peerreviewed scientific journals

This role offers the opportunity to advance your career while contributing to cuttingedge 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.

Additional Information :

The base salary range for this position is $212000 $369000. Base salary offered is determined through an analytical approach utilizing a combination of factors including but not limited to relevant skills & experience job location and internal equity.

Regular employees are eligible to receive both short term and longterm incentives including cash bonus and equity incentive opportunities designed to reward recent achievements and recognize your future potential based on individual business unit and company performance.

In addition to compensation Biogen offers a full and highly competitive range of benefits designed to support our employees and their families physical financial emotional and social wellbeing; including but not limited to:

Medical Dental Vision & Life insurances

Fitness & Wellness programs including a fitness reimbursement

Short and LongTerm Disability insurance

A minimum of 15 days of paid vacation and an additional endofyear shutdown time off (Dec 26Dec 31

Up to 12 company paid holidays 3 paid days off for Personal Significance

80 hours of sick time per calendar year

Paid Maternity and Parental Leave benefit

401(k) program participation with company matched contributions

Employee stock purchase plan

Tuition reimbursement of up to $10000 per calendar year

Employee Resource Groups participation

Why Biogen

We are a global team with a commitment to excellence and a pioneering spirit. As a midsized biotechnology company we provide the stability and resources of a wellestablished business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning growth and expanding their skills. Above all we work together to deliver lifechanging medicines with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds cultures and perspectives make us a stronger and more innovative company and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.

All qualified applicants will receive consideration for employment without regard to sex gender identity or expression sexual orientation marital status race color national origin ancestry ethnicity religion age veteran status disability genetic information or any other basis protected by federal state or local law. Biogen is an EVerify Employer in the United States.