Neurocrine Biosciences · 7 hours ago
Assoc. Scientific Director, Translational Science
Neurocrine Biosciences is a leading neuroscience-focused biopharmaceutical company dedicated to discovering life-changing treatments for patients with neurological disorders. The Assoc. Scientific Director will lead clinical biomarker efforts, collaborate with cross-functional teams, and establish robust clinical development plans to translate preclinical research into clinical programs.
BiotechnologyHealth CarePharmaceutical
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
Qualification
Required
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
Benefits
Annual bonus with a target of 30% of the earned base salary
Eligibility to participate in our equity based long term incentive program
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
Company
Neurocrine Biosciences
Neurocrine Biosciences engages in the discovery and development of drugs for the treatment of neurological and endocrine-related diseases.
H1B Sponsorship
Neurocrine Biosciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (16)
2024 (9)
2023 (8)
2022 (2)
2021 (5)
2020 (6)
Funding
Current Stage
Public CompanyTotal Funding
$260MKey Investors
Venrock
2015-02-19Post Ipo Equity· $250M
2009-12-17Post Ipo Equity· $10M
1996-05-31IPO
Recent News
BioWorld Financial Watch
2026-01-16
Company data provided by crunchbase