Principal Scientist, Translational Medicine

Neurocrine Biosciences • San Diego, CA

2d • $130,800 - $179,000

About The Position

As a key contributor to the clinical biomarker strategy, accountable for working effectively with cross-functional teams on the planning, implementation, and execution of clinical biomarker testing, and data delivery activities. Integrate scientific and operational expertise through cross functional partnerships, management of external CROs, strategic project planning and facilitating key biomarker execution components of clinical trials.

Requirements

• 10+ years of applicable experience/training OR BS/BA degree in Biology, Chemistry, or related science field AND 6+ years of relevant experience, or OR Master’s in Biology, Chemistry, or related science field AND 4+ years of related experience, or OR PharmD or PhD AND 2+ years of related experience
• Consistent ability to meet multiple deadlines, with a high degree of accuracy and efficiency
• Excellent written, presentation, and verbal communication skills
• Proactive, innovative, with exceptional problem-solving and analytical skills
• Ability to lead and/or work as part of a team; typically leads and trains junior scientists and/or other team members
• Working knowledge of FDA guidance on biomarker method validation and related regulatory aspects
• Established scientific background on clinical biomarkers and commonly used methodologies
• Deep expertise on at least one biomarker platform (i.e. neuroimaging, electrophysiology, or biofluid biomarkers), with general broad understanding of how other biomarker modalities can be integrated into clinical development strategies
• Experience with clinical study operations teams and understanding of clinical drug development strategic planning of clinical research
• Extensive experience working with CROs to support clinical assay development and sample testing
• Experience with regulatory filings and interactions.
• Experience in GLP, GMP and/or GCP regulated environments and studies

Responsibilities

• Collaborate with biomarker scientists and clinical teams to design biomarker strategies for clinical trials, including selecting appropriate assay platforms, defining assay parameters, and developing protocols
• Serve as assay SME in at least one technical area to independently identify and guide CROs with biomarker validation, experimental design, troubleshooting, and method development as required
• Maintain a network of specialty biomarker vendors to help select the best CROs for the proposed work and ensure vendors meet quality standards and certification
• Work in partnership with scientific/clinical leads, procurement, contracting and compliance teams to negotiate contracts, prepare statements of work, oversee contract execution status and ensure deliverables meet program requirements.
• Manage relationships with CROs to ensure biomarker data is collected in an ethical and high-quality manner.
• Ensure data is reported to meet development timelines while ensuring data quality and assay performance
• Work closely with data management to establish data collection, data reconciliation, and transfer specifications with CROs
• Contribute to the preparation of clinical documents such as lab report templates, lab manuals, informed consent forms, eCRF, sample/data management plan, early development plans, and site training materials
• When relevant, oversee the collection, handling, storage, and shipment of clinical trial samples to external laboratories
• Apply and adhere to ICH/GCP, sample storage procedures, sample management best practices, and ethical guidelines
• Maintain biomarker related budgets for assay development/validation, in-study sample testing, and long-term sample storage
• Other duties as assigned

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

What This Job Offers

• Job Type: Full-time
• Career Level: Principal