Associate Director, Clinical Biomarkers Lead
Biogen
2 months ago
Remote friendly (San Francisco, CA)
United States
Clinical Research and Development
Associate Director, Clinical Biomarkers Lead
Responsibilities:
- Develop and implement comprehensive biomarker strategies for therapeutic programs in clinical development, including pivotal/phase 3 programs.
- Drive generation, analysis, and interpretation of biomarker data in clinical studies with cross-functional program teams.
- Provide guidance and mentorship for biomarker strategy development and implementation.
- Coordinate and align biomarker activities with stakeholders in research, clinical development, regulatory, medical affairs, and commercial.
- Identify and partner with external academic collaborators; maintain sponsored research agreements.
- Matrix manage biomarker assay development scientists and oversee/manage outsourced projects with CROs, technology partners, and academics.
- Support planning and execution of clinical trials; author and/or provide senior review of clinical protocols and regulatory/medical affairs documents/filings.
- Collaborate across immunology research, translational immunology, clinical research, biometrics, and clinical pharmacology to execute translational studies and interpret biomarker datasets.
- Engage regulators and industry professionals via conferences, workshops, consortia, and publications.
Qualifications / Required Skills:
- PhD with 10+ years industry experience.
- 4+ years leading/implementing clinical biomarker strategies in immune mediated diseases, including late stage/pivotal studies.
- Exceptional communication skills delivering biomarker-focused data/presentations to varied audiences.
- Demonstrated biomarker leadership (manuscripts, regulatory documents, regulator interactions).
- Strong understanding of clinical development and life cycle management.
- Proficiency with cytometry and immunoassay technologies and their clinical implementation limitations/advantages.
- Ability to quickly learn relevant biology, pathways, MOA, and disease indications.
- Proven scientific leadership and matrix management of cross-functional teams.
- Ability to prioritize and deploy resources to meet goals and timelines.
Benefits (if explicitly stated):
- Medical, Dental, Vision & Life insurance; fitness/wellness reimbursement; short- and long-term disability; paid vacation (minimum 15 days) and end-of-year shutdown; paid holidays and Personal Significance days; sick time; paid maternity/parental leave; 401(k) match; employee stock purchase plan; tuition reimbursement up to $10,000/year; employee resource groups participation.
Responsibilities:
- Develop and implement comprehensive biomarker strategies for therapeutic programs in clinical development, including pivotal/phase 3 programs.
- Drive generation, analysis, and interpretation of biomarker data in clinical studies with cross-functional program teams.
- Provide guidance and mentorship for biomarker strategy development and implementation.
- Coordinate and align biomarker activities with stakeholders in research, clinical development, regulatory, medical affairs, and commercial.
- Identify and partner with external academic collaborators; maintain sponsored research agreements.
- Matrix manage biomarker assay development scientists and oversee/manage outsourced projects with CROs, technology partners, and academics.
- Support planning and execution of clinical trials; author and/or provide senior review of clinical protocols and regulatory/medical affairs documents/filings.
- Collaborate across immunology research, translational immunology, clinical research, biometrics, and clinical pharmacology to execute translational studies and interpret biomarker datasets.
- Engage regulators and industry professionals via conferences, workshops, consortia, and publications.
Qualifications / Required Skills:
- PhD with 10+ years industry experience.
- 4+ years leading/implementing clinical biomarker strategies in immune mediated diseases, including late stage/pivotal studies.
- Exceptional communication skills delivering biomarker-focused data/presentations to varied audiences.
- Demonstrated biomarker leadership (manuscripts, regulatory documents, regulator interactions).
- Strong understanding of clinical development and life cycle management.
- Proficiency with cytometry and immunoassay technologies and their clinical implementation limitations/advantages.
- Ability to quickly learn relevant biology, pathways, MOA, and disease indications.
- Proven scientific leadership and matrix management of cross-functional teams.
- Ability to prioritize and deploy resources to meet goals and timelines.
Benefits (if explicitly stated):
- Medical, Dental, Vision & Life insurance; fitness/wellness reimbursement; short- and long-term disability; paid vacation (minimum 15 days) and end-of-year shutdown; paid holidays and Personal Significance days; sick time; paid maternity/parental leave; 401(k) match; employee stock purchase plan; tuition reimbursement up to $10,000/year; employee resource groups participation.