Associate Director, Clinical Biomarkers Lead
Scorpion Therapeutics
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 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. #J-18808-Ljbffr Scorpion Therapeutics
$161k - $222k
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