Assoc. Scientific Director, Translational Medicine

Role Summary

Assoc. Scientific Director, Translational Medicine will collaborate with cross-functional teams to evaluate therapeutic targets, build translatable biomarker strategies, and establish robust clinical development plans. The role leads clinical biomarker efforts through vendor selection, method development/validation, integration into clinical protocols, execution of sample testing at CROs, and biomarker data analysis/interpretation. The individual will have a strong strategic role on project teams responsible for translating preclinical research into clinical programs through influencing IND data packages, interacting with the FDA/EMA, building relationships with KOLs. The ideal candidate will have experience in Neurology, Immunology and/or Endocrinology. Gene therapy, and other biologics would be helpful.

Responsibilities

• Establishes translational plans for designated programs and participate with senior management to align biomarker strategies to program goals to enable data-driven decisions
• Provides disease biology expertise to clinical study teams and functional areas such as regulatory, clinical development, and clinical operations
• Provides input to study design, protocol concepts/protocols preparation, statistical analysis plans, and reporting within assigned programs to yield high value mechanistic insight for future critical decisions
• Collaborates with external opinion leaders. internal clinicians, research scientists and clinical operations to ensure appropriate biomarkers are incorporated within clinical studies validated appropriately for their intended use
• Support identification and development of novel biomarker platforms
• Engage with CROs to develop and validate clinical biomarker assays in a fit-for-purpose manner
• Manages clinical biomarker data delivery and analysis and associated timelines by working with relevant internal functions and CROs
• Reviews and interprets scientific knowledge of competitor landscape (molecule / indication)
• Participate with team members to prepare abstracts, manuscripts, and presentations for external meetings as well as author biomarker sections of regulatory documents (IB, IND sections)
• Remains up-to-date with current information on biomarker regulations, guidelines, and practices and therapeutic area knowledge and ensures consistent best practice across all activities
• Other duties as assigned

Qualifications

• BS/BA degree in Biology, Chemistry, or related science field AND 8+ years of relevant experience
• Master’s in Biology, Chemistry, or related science field AND 6+ years of related experience
• PharmD or PhD AND 5+ years of related experience
• Strong knowledge of several areas within experimental medicine and biomarker development with deep expertise in at least one area
• Ability to work effectively in cross-functional teams
• Skill in evaluating data and data quality from multiple sources
• Capable of making data-driven decisions that impact project/program success
• Recognized as an emerging thought leader with technical expertise in the field
• Experience in immunoassay development and GxP-based biomarker platform deployment
• Working knowledge of FDA guidance on bioanalytical method validation and related regulatory aspects
• Understanding of biomarker assay validation and lab certification levels to support the intended purpose of clinical assay
• Strong grasp of FDA’s BEST resource with specific knowledge around surrogate endpoints
• Extensive experience working with CROs to support clinical assay development and sample testing
• Excellent communication and presentation skills
• Experience with regulatory filings and interactions
• Demonstrated expertise in Translational Science
• Passion and tenacity to advance patient-focused research

Education

• Bachelor’s degree in Biology, Chemistry, or related science field
• Advanced degrees (Master’s, PharmD, or PhD) relevant to translational medicine