Clinical Biomarkers Lead at Biogen in South San Francisco, California

Job Description:

Job Description

About This Role

HI-Bio, Inc., a Biogen company, is seeking a highly motivated and experienced leader to support clinical biomarker development activities for our portfolio of immunology clinical programs. As the Clinical Biomarkers Lead, you will be responsible for the oversight of the development, implementation, and execution of biomarker strategies for programs across the HI-Bio portfolio. Reporting directly to the HI-Bio head of Biomarker and Bioanalytical Sciences and as a key member of the development team, you will support end-to-end biomarker development for our novel therapeutic candidates. This position is based in South San Francisco, California and required frequent onsite presence. Candidates must be within commutable distance or able to self-relocate to be considered.

What You'll Do

• Develop and implement comprehensive biomarker strategies for therapeutic programs in clinical development, including pivotal/phase 3 programs


• Drive the generation, analysis, and interpretation of biomarker data in clinical studies as a key member of cross-functional program teams


• Provide guidance and mentorship to members of the group focused on biomarker strategy development and implementation


• Liaise with relevant stakeholders in research, clinical development, regulatory, medical affairs and commercial to coordinate and align biomarker activities in support of immunology therapeutic programs


• Build strong partnerships with external collaborators by identifying potential academic partners to accelerate achievement of biomarker goals and maintain existing sponsored research agreements


• Matrix manage biomarker assay development scientists and oversee/manage multiple outsourced projects with contract research laboratories, technology partners, and academics


• Support the planning and execution of clinical trials; Author and/or provide senior review of clinical protocols, medical affairs, and regulatory documents/filings


• Collaborate with immunology research, translational immunology, clinical research, biometrics, clinical pharmacology, and others to execute translational studies and analyze and interpret biomarker datasets


• Actively engage with regulators and industry professionals via conference presentations, workshops, consortia, and publications to influence best practices for biomarker development and clinical implementation

Who You Are

You are an experienced biomarker leader with a proven track record of developing and delivering on biomarker strategies across all stages of drug development. You will have excellent strategic thinking, communication, and collaboration skills while being able to influence without authority and efficiently drive alignment amongst multiple stakeholders to efficiently progress therapeutic programs in clinical development.

 

Qualifications

Required Skills

• PhD with 12+ years relevant experience


• 5+ years direct experience leading/implementing clinical biomarker strategies in immune mediated diseases including for late-stage/pivotal studies


• Exceptional verbal and written communication skills; proven ability to deliver clear, concise biomarker focused data and presentations tailored to different audiences including commercial colleagues


• Demonstrated leadership in biomarker sciences including authoring manuscripts, regulatory documents, and direct interactions with regulators


• Strong understanding of the clinical development and life cycle management process


• Well versed in relevant technologies, particularly cytometry and immunoassay technologies with strong understanding of inherent advantages and limitations specifically with respect to clinical implementation


• Ability to quickly absorb new information and develop an understanding of the relevant biology, pathway, MOA, and disease indication(s)


• Proven scientific leadership and matrix management of high performing individuals and cross functional teams required


• Ability to prioritize and deploy resources effectively and appropriately to meet key goals and timelines

Preferred Skills

• Experience in B cell immunology and/or clinical programs in nephrology and/or solid organ transplant is a plus

The base compensation range for this role is $168,000.00-$279,000.00k. Base salary is determined by a combination of factors including, but not limited to, job related years of relevant experience, internal equity, and location of the job. Additionally, this role is eligible for participation in Biogen's LTI grants and other incentive programs. Biogen offers a full range of benefits that include medical, dental, life, long and short-term disability insurances, vacation, end-of-year shutdown, and 401K participation and matching contributions. 

Additional Information

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established 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 life-changing 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 E-Verify Employer in the United States.

 

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