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
Requirements
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
Preferred Skills
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 s
Benefits
Dental insuranceVision insurancePaid time offEquity / stock optionsPerformance bonus
Additional Information
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.
Biogen · San Francisco, CA