Associate Director, Biomarker Science

Scorpion Therapeutics; United States; Hybrid; USD 150,000 - 220,000; Full time

Job summary

Scorpion Therapeutics in the United States seeks a lead Translational Biology professional to advance biomarker strategies across nonclinical, translational, and clinical programs, with emphasis on early/translational efforts. You will collaborate with nonclinical, research operations, and molecular biology leads to drive data generation and decision making.

The role includes managing CROs for biomarker data generation, contributing to regulatory writing (INDs, CTAs, NDAs), and representing

Qualifications

• PhD in Pharmacology, Biochemistry, Bioinformatics or related field.
• 4+ years biopharma translational research experience.
• Authoring/regulatory documentation experience.
• Bioassay development and biomarker qualification under regulatory guidelines.
• Experience with -omics datasets (RNASeq, single cell, proteomics).
• Vendor management and cross-functional project leadership.

Responsibilities

• Assist in developing and implementing biomarker strategies aligned with program development and regulatory plans.
• Collaborate with nonclinical, research operations, and molecular biology leads to support biomarker data generation.
• Conduct literature reviews to identify novel PK/PD biomarkers and develop implementation plans.
• Perform data analysis to interpret non-clinical and clinical PD data and guide decisions.
• Oversee CROs for non-clinical/clinical data generation, including assay development and validation.
• Represent Translational Biology on internal sub-teams to drive milestones and long-term planning.
• Support data disclosure materials and biomarker dataset presentation efforts.
• Participate in regulatory writing for translational/biomarker documents (INDs, CTAs, NDAs) and RFIs.

Skills

Bioassay development

Big data / -omics

Technical writing

Regulatory document authoring

Vendor management

Cross-functional communication

Translational biology leadership

Education

PhD in Pharmacology/Biochemistry/Bioinformatics or related field

Job description

Primary Responsibilities Include

• Assist in developing and implementing biomarker strategies aligned with program development and regulatory plans (nonclinical, translational, clinical), especially early/translational programs
• Collaborate with nonclinical, research operations, and molecular biology leads to support biomarker data generation
• Conduct literature reviews to identify novel PK/PD biomarkers and develop implementation plans for non-clinical and clinical studies
• Perform extensive data analysis to interpret non-clinical and clinical PD data and guide decision-making
• Oversee Contract Research Organizations for non-clinical/clinical data generation, including assay development and validation
• Represent Translational Biology on internal clinical/non-clinical sub-teams to drive milestones and long-term planning
• Support internal/external data disclosure materials and biomarker dataset presentation efforts
• Participate in regulatory writing for translational/biomarker documents (INDs, CTAs, NDAs) and Requests for Information

Desired Education and Skills

• PhD in Pharmacology, Biochemistry, Bioinformatics or related field + 4+ years biopharma translational research experience
• Expertise in neurobiology/neuromuscular biology, siRNA therapeutics, and rare disease drug development
• Bioassay development (protein-binding assay platforms)
• Experience with big datasets and/or -omics (RNASeq, single cell, proteomics)
• Authoring/reviewing technical, clinical, and regulatory documents
• Qualification/validation of bioanalytical assays/biomarkers under FDA, EMA, ICH GCP/GLP and related guidelines
• Vendor management
• Cross-functional/matrix project management; exceptional verbal and written communication

Hybrid: expected to work on-site in the U.S. and/or attend in-person events.