Associate Director, Clinical Biomarkers Lead

Biogen, Inc.; San Francisco (CA); On-site; USD 161,000 - 222,000; Full time

Benefits offered by this job

Medical, Dental, Vision, & Life ins.

Fitness & Wellness programs

401(k) with match

Tuition reimbursement

Job summary

Biogen is seeking an Associate Director, Clinical Biomarkers Lead to oversee biomarker development strategies across immunology and neuromuscular programs. You will lead end-to-end biomarker efforts, overseeing client collaborations and cross-functional teams on West Coast initiatives.

The role requires a PhD with extensive biomarker leadership experience, strong communication, and the ability to influence across research, clinical, regulatory, and commercial groups.

Qualifications

• PhD with 10+ years of industry experience.
• 4+ years direct experience leading/implementing clinical biomarker strategies in immune mediated diseases including late-stage studies.
• Exceptional communication skills with ability to present biomarker data clearly to diverse audiences.
• Demonstrated leadership in biomarker sciences, including manuscripts, regulatory documents, and regulator interactions.
• Strong understanding of clinical development and lifecycle management.
• Well versed in cytometry and immunoassay technologies for clinical use.
• Ability to rapidly absorb new biology and disease indications.
• Proven scientific leadership and matrix management of cross-functional teams.
• Ability to prioritize and deploy resources to meet key milestones.

Responsibilities

• Develop and implement comprehensive biomarker strategies for clinical programs including pivotal/phase 3.
• Drive generation, analysis, and interpretation of biomarker data in clinical studies with cross-functional teams.
• Mentor group members on biomarker strategy development and implementation.
• Coordinate biomarker activities with research, clinical development, regulatory, medical affairs, and commercial teams.
• Build partnerships with academics and CROs to accelerate biomarker goals.
• Manage biomarker assay development scientists and outsourced projects with labs and partners.
• Support planning and execution of clinical trials; author/review protocols and regulatory documents.
• Collaborate on translational studies and analysis of biomarker datasets.
• Engage regulators and industry groups to influence biomarker practices.

Skills

Biomarker strategy leadership

Scientific leadership

Regulatory interactions

Education

PhD in relevant field

Tools

Cytometry

Immunoassays

Biomarker assays

Job description

About This Role

We are seeking a highly motivated and experienced Associate Director, Clinical Biomarkers Lead to support clinical biomarker development activities for our portfolio of immunology and neuromuscular clinical programs. As the Associate Director, Clinical Biomarkers Lead, you will be responsible for the oversight of the development, implementation, and execution of biomarker strategies for programs across the Biogen portfolio. Reporting directly to the West Coast Hub Head of Clinical Biomarkers and as a key member of the development team, you will support end-to-end biomarker development for our novel therapeutic candidates.

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 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.

Required Skills

• PhD with 10+ years industry experience
• 4+ years direct experience leading/implementing clinical biomarker strategies in immune mediated diseases including for late stage/pivotal studies
• Exceptional communication skills with 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

Job Level: Management

Additional Information

The base compensation range for this role is: $161,000.00-$222,000.00 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 long-term 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 well-being; including, but not limited to:

• Medical, Dental, Vision, & Life insurances
• Fitness & Wellness programs including a fitness reimbursement
• Short- and Long-Term Disability insurance
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 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 $10,000 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 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 Biogen.

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.