Associate Director, Clinical Biomarker Development
Redwood City, California, United States
$186k-$233k/yrHybridFull Time
Revolution MedicinesNASDAQ: RVMD: Developing precision oncology therapies for RAS-addicted cancers
3+ YOEPh.D. required; 3+ years clinical biomarker/assay development in industry; experience with assay development, validation and clinical implementation; CRO management; strong communication and independent problem-solving skills.
IntuitiveNASDAQ: ISRG: Robotic-assisted systems for minimally invasive surgery.
5+ YOEExperience managing multi-center premarket and post-market clinical studies, protocol/ICF development, GCP knowledge, literature review, contract/budget negotiation, team leadership, and 5+ years clinical research experience or equivalent.
Align TechnologyNASDAQ: ALGN: Designs and manufactures clear aligners and intraoral scanners.
6+ YOEBachelor's required (Master's preferred); 6+ years clinical research experience preferred; 2-5 years as Senior CRA; experience running clinical studies, familiarity with FDA/ICH-GCP, project management and stakeholder communication.
San Francisco or San Jose or Sunnyvale or Palo Alto or South San Francisco or Fremont or Oakland
$145k-$175k/yrRemoteFull Time
DanaherNYSE: DHR: Develops scientific instruments and diagnostic tools for healthcare markets.
5+ YOEBachelor's degree in a scientific field, 5+ years of life sciences sales experience, technical molecular and cell biology knowledge, and experience selling CDMO or clinical drug development services.
Akura Medical: Developing catheter-based mechanical thrombectomy platforms for VTE treatment.
7+ YOE7+ years managing medical device clinical trials including start-up, monitoring oversight, and closeout; strong knowledge of ICH GCP, ISO 14155, and FDA regulations; experience with CROs, EDC, budgeting, and regulatory inspections.
Associate Medical Director, Clinical Development - Job ID: 1912, 1913, 1914
Palo Alto, California, United States
$255k-$265k/yrHybridFull Time
Ascendis PharmaNASDAQ: ASND: Develops long-acting prodrug therapies for rare diseases and oncology.
3+ YOEM.D. required; completion of residency/fellowship preferred; physician licensure and board certification preferred; ≥3 years industry experience and ≥2 years clinical trial design experience; strong communication and leadership skills.
5+ YOE5+ years clinical data management experience in trials; bachelor’s or higher preferred. Experience with SAS, EDC (Rave/Medrio), CDISC/SDTM, vendor/CRO management, CDISC compliance, and relevant regulations (ICH, GCDMP, 21CFR Part 11).
Stanford University: A private research university providing higher education and research.
5+ YOE3+ MgmtBachelor's degree and 5 years of clinical research experience required; 3 years of management experience, regulatory knowledge, and Microsoft Office, database, and EHR proficiency required. Master's and oncology experience preferred.
Microsoft Office, Electronic Health Record (EHR), REDCap Cloud, EPIC, database applications
U.S. Renal Care: Provider of dialysis treatment and kidney disease management services.
Coordinate clinical and operational processes, maintain regulatory compliance, oversee documentation, manage staff development, and support patient care in a dialysis clinic.
Summit TherapeuticsNASDAQ: SMMT: Developing oncology therapies to improve patient quality of life.
10+ YOE10+ years clinical data management experience in biotech/pharma, EDC and data standards experience, MedDRA/WHODRUG knowledge, leadership and CRO/vendor oversight, understanding of FDA/ICH/GCP and clinical trial data processes.
DELFI Diagnostics: Developing blood-based tests for early cancer detection.
8+ YOE6+ MgmtPhD or MD required; 8+ years leading clinical study design and development; 3–5 years IVD diagnostics experience; 6+ years management; knowledge of ICH E6(R3) GCP, ISO 14155, ISO 13485, 21 CFR Part 820; oncology preferred.
NLP, LLM, EHR, FAIR principles, FHIR-OMOP, Common Data Models
Senior Manager/Associate Director Clinical Monitoring Strategy & Optimization
Menlo Park or Waltham or United States
$161k-$208k/yrHybridFull Time
Oruka TherapeuticsNASDAQ: ORKA: Develops long-acting biologics for chronic skin and inflammatory diseases.
6+ YOEBachelor's in life sciences or nursing,6+ years clinical operations experience,experience overseeing clinical monitoring and CROs,ICH-GCP and global regulatory knowledge,ability to support inspections and travel 60-80%.
Taiho Oncology: Develops and commercializes orally administered anti-cancer medicines.
3+ YOEDoctorate (PhD or PharmD) required, oncology and clinical development experience (3+ years), ability to review clinical data and regulatory documents, knowledge of US/EU drug development, strong scientific communication skills.
AbbottNYSE: ABT: Manufactures medical devices, diagnostics, and nutritional health products.
8+ YOEBachelor's degree and minimum 8 years conducting clinical studies; experience with medical device trials, IDE/TAVR preferred; knowledge of device regulations; experience with safety, physician management, and external research committees.
N-Power Medicine: Clinical research platform for oncology drug development
8+ YOE8+ years product lifecycle experience in software, strong Agile and release management skills, A/B testing and QA experience, ability to bridge product, engineering, and clinical teams.
Karius: Genomic blood tests for rapid identification of infectious pathogens.
5+ YOEBachelor's in biological science,5+ years clinical laboratory experience with ≥4 years in molecular biology,ability to run NGS workflows,manage projects,author SOPs,and support LIMS and automation.
Taiho OncologyTokyo Stock Exchange: 4578: Develops and sells oral cancer medications for various tumors.
12+ YOEDoctoral degree preferred in pharmacology or quantitative sciences; 12+ years industry experience in clinical development (oncology); expertise in PK/PD, PopPK, ER, QSP, modeling & simulation; regulatory interaction experience; team management; proficiency with WinNonlin and MS Office.
Windows, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, WinNonlin
Stanford University: Private research university providing academic education and medical services.
2+ YOEBachelor's degree plus 2 years clinical research experience (or equivalent). Requires proficiency with Microsoft Office and databases, knowledge of HIPAA/FDA/IRB/GCP, medical terminology; SoCRA/ACRP certification preferred.