About the Role:
Associate Scientific Director, Translational Medicine will drive the translational strategy for neurology programs from research through late clinical development. Collaborate with cross functional teams to evaluate therapeutic targets, build translatable biomarker strategies, and establish robust clinical development plans. Lead 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.

Your Contributions (include, but are not limited to):

• 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

Requirements:

• BS/BA degree in Biology, Chemistry, or related science field AND 8+ years of relevant experience OR
• Master's in Biology, Chemistry, or related science field AND 6+ years of related experience OR
• 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

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The annual base salary we reasonably expect to pay is $173,600.00-$237,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.