Principal Scientist, Translational Medicine
Neurocrine Biosciences
7 hours ago
Remote friendly (San Diego, CA)
United States
Clinical Research and Development
About the Role
As a key contributor to the clinical biomarker strategy, responsible for working with cross-functional teams on planning, implementation, execution of clinical biomarker testing, and data delivery. Integrate scientific and operational expertise through cross-functional partnerships, CRO management, strategic project planning, and facilitating key biomarker execution components of clinical trials.
Your Contributions (Responsibilities)
- Collaborate with biomarker scientists and clinical teams to design biomarker strategies (assay platform selection, assay parameters, and protocols).
- Serve as assay SME in at least one technical area; guide CROs on biomarker validation, experimental design, troubleshooting, and method development.
- Maintain a network of specialty biomarker vendors; select best CROs and ensure quality standards/certification.
- Partner with scientific/clinical leads, procurement, contracting, and compliance to negotiate contracts, prepare SOWs, oversee execution status, and ensure deliverables meet requirements.
- Manage CRO relationships to ensure ethical, high-quality biomarker data; meet development timelines while ensuring data quality/assay performance.
- Work with data management to establish data collection, reconciliation, and transfer specifications with CROs.
- Contribute to clinical documents (lab templates/manuals, informed consent, eCRF, sample/data management plan, early development plans, site training materials).
- When relevant, oversee collection/handling/storage/shipment of clinical trial samples to external labs.
- Apply/adhere to ICH/GCP, sample storage procedures, sample management best practices, and ethical guidelines.
- Maintain biomarker budgets (assay development/validation, in-study testing, long-term sample storage).
Requirements
- 10+ years applicable experience/training OR BS/BA in Biology/Chemistry or related + 6+ years OR Master’s in Biology/Chemistry or related + 4+ years OR PharmD/PhD + 2+ years.
- Strong communication skills; proactive, innovative, strong problem-solving/analytical skills.
- Ability to lead and/or work in teams; typically leads and trains junior staff.
- Working knowledge of FDA biomarker method validation guidance.
- Background in clinical biomarkers and commonly used methodologies.
- Deep expertise in at least one biomarker platform (neuroimaging, electrophysiology, or biofluid) and understanding of integrating other modalities.
- Experience with clinical study operations/clinical research strategic planning.
- Extensive CRO experience supporting assay development and sample testing.
- Regulatory filing/interactions experience.
- Experience in GLP/GMP and/or GCP regulated environments.
Benefits
- Retirement savings plan (company match); paid vacation/holidays/personal days; paid caregiver/parental and medical leave; health benefits (medical, prescription drug, dental, vision).
- Annual bonus target: 30% of earned base salary; eligibility for equity-based long-term incentive.
- Annual base salary (expected): $130,800.00–$179,000.00.
As a key contributor to the clinical biomarker strategy, responsible for working with cross-functional teams on planning, implementation, execution of clinical biomarker testing, and data delivery. Integrate scientific and operational expertise through cross-functional partnerships, CRO management, strategic project planning, and facilitating key biomarker execution components of clinical trials.
Your Contributions (Responsibilities)
- Collaborate with biomarker scientists and clinical teams to design biomarker strategies (assay platform selection, assay parameters, and protocols).
- Serve as assay SME in at least one technical area; guide CROs on biomarker validation, experimental design, troubleshooting, and method development.
- Maintain a network of specialty biomarker vendors; select best CROs and ensure quality standards/certification.
- Partner with scientific/clinical leads, procurement, contracting, and compliance to negotiate contracts, prepare SOWs, oversee execution status, and ensure deliverables meet requirements.
- Manage CRO relationships to ensure ethical, high-quality biomarker data; meet development timelines while ensuring data quality/assay performance.
- Work with data management to establish data collection, reconciliation, and transfer specifications with CROs.
- Contribute to clinical documents (lab templates/manuals, informed consent, eCRF, sample/data management plan, early development plans, site training materials).
- When relevant, oversee collection/handling/storage/shipment of clinical trial samples to external labs.
- Apply/adhere to ICH/GCP, sample storage procedures, sample management best practices, and ethical guidelines.
- Maintain biomarker budgets (assay development/validation, in-study testing, long-term sample storage).
Requirements
- 10+ years applicable experience/training OR BS/BA in Biology/Chemistry or related + 6+ years OR Master’s in Biology/Chemistry or related + 4+ years OR PharmD/PhD + 2+ years.
- Strong communication skills; proactive, innovative, strong problem-solving/analytical skills.
- Ability to lead and/or work in teams; typically leads and trains junior staff.
- Working knowledge of FDA biomarker method validation guidance.
- Background in clinical biomarkers and commonly used methodologies.
- Deep expertise in at least one biomarker platform (neuroimaging, electrophysiology, or biofluid) and understanding of integrating other modalities.
- Experience with clinical study operations/clinical research strategic planning.
- Extensive CRO experience supporting assay development and sample testing.
- Regulatory filing/interactions experience.
- Experience in GLP/GMP and/or GCP regulated environments.
Benefits
- Retirement savings plan (company match); paid vacation/holidays/personal days; paid caregiver/parental and medical leave; health benefits (medical, prescription drug, dental, vision).
- Annual bonus target: 30% of earned base salary; eligibility for equity-based long-term incentive.
- Annual base salary (expected): $130,800.00–$179,000.00.