Assoc. Scientific Director, Translational Science

Neurocrine Biosciences•San Diego, CA

About The Position

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.

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

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

Benefits

retirement savings plan (with company match)
paid vacation, holiday and personal days
paid caregiver/parental and medical leave
health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans

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