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About the Role
The Associate Director, Clinical Biomarkers Lead will support clinical biomarker development for immunology and neuromuscular programs. This role involves overseeing the development, implementation, and execution of biomarker strategies across the Biogen portfolio, contributing to end-to-end biomarker development for novel therapeutic candidates.
Responsibilities
- 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.
- Provide guidance and mentorship to team members focused on biomarker strategy development and implementation.
- Liaise with stakeholders in research, clinical development, regulatory, medical affairs, and commercial to coordinate biomarker activities.
- Build strong partnerships with external collaborators by identifying potential academic partners and maintaining sponsored research agreements.
- Matrix manage biomarker assay development scientists and oversee 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 various departments to execute translational studies and analyze biomarker datasets.
- Engage with regulators and industry professionals via conference presentations, workshops, consortia, and publications to influence best practices for biomarker development and clinical implementation.
Requirements
- 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.
- 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 a strong understanding of their advantages and limitations for clinical implementation.
- Ability to quickly absorb new information and develop an understanding of relevant biology, pathways, MOA, and disease indications.
- Proven scientific leadership and matrix management of high-performing individuals and cross-functional teams.
- Ability to prioritize and deploy resources effectively and appropriately to meet key goals and timelines.
Skills
- Biomarker strategy development
- Biomarker data analysis and interpretation
- Clinical trial execution
- Regulatory document authoring
- External collaboration management
- Matrix management
- Cytometry
- Immunoassay technologies
- Scientific leadership
- Communication
- Strategic thinking
- Collaboration
- Influencing without authority
Location
- West Coast
Work Type
- Full-time
Experience Level
- Associate Director
- Management
Education Level
- PhD
Salary/Compensations
- $161,000.00-$222,000.00
Benefits
- Short-term and long-term incentives
- Cash bonus
- Equity incentive opportunities
- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- Fitness & Wellness programs
- Fitness reimbursement
- Short-term Disability insurance
- Long-term Disability insurance
- 15 days of paid vacation
- End-of-year shutdown time off (Dec 26-Dec 31)
- 12 company paid holidays
- 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity Leave
- Paid Parental Leave
- 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
About the Company
- Biogen is a global team with a commitment to excellence and a pioneering spirit.
- As a mid-sized biotechnology company, Biogen provides the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact.
- The team encompasses talented and passionate achievers with unparalleled opportunities for learning, growth, and skill expansion.
- Biogen works together to deliver life-changing medicines, with every role playing a vital part in the mission: Caring Deeply. Achieving Excellence. Changing Lives.
Equal Opportunity
- 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.