about 4 hours ago
Sr. Manager, Clinical Operations & Strategic Alliances
Pleasanton, California, USA
$173,100-$234,100 / year
full-timeseniorBiotechnology
Description
You will drive the operational execution and strategic management of high-impact alliances to advance diagnostic applications for single cell and spatial technologies. You will manage a portfolio of academic collaborations and lead large-scale clinical research studies, ensuring compliance with timelines, budgets, and regulatory standards.
Requirements
- Advanced degree (M.S., PharmD, Ph.D., M.B.A.) in Life Science, Clinical, or related field.
- 8+ years of relevant industry experience with 4-5 years in Clinical Operations and Alliance/Program Management within diagnostics, biotechnology, or pharmaceutical industry.
- Direct experience managing research studies involving large numbers of patient samples and complex molecular testing or biomarkers.
- Deep understanding of clinical study execution, site management, and clinical sample logistics and chain of custody.
- Direct experience managing high-value strategic alliances and driving collaboration through research, development, or commercialization agreements.
- Demonstrated ability to manage competing priorities, resolve complex operational problems, and drive results.
- Thrives in fast-paced environment with a 'roll up your sleeves' mentality.
- Excellent communication, organizational, and leadership skills.
- Comfortable leading through ambiguity and change.
- Exceptional at building collaborative relationships with diverse stakeholders.
- Willing to travel up to 25%.
- Startup or small biotech experience preferred.
- Familiarity with CLIA/CAP standards preferred.
Responsibilities
- Manage the operational execution of large-scale, longitudinal clinical research studies according to established agreements with academic institutions.
- Own and drive clinical research study timelines, deliverables, and operational plans; identify and mitigate operational risks.
- Establish and enforce auditable procedures for sample collection, tracking, and chain of custody.
- Manage study budgets, including reimbursement, equipment provisioning, and consumables.
- Ensure compliance with IRB protocols, patient consent requirements, and GCLP/CLIA standards.
- Manage a diverse portfolio of academic collaborations and strategic partnerships to track toward milestones and outcomes.
- Ensure transparent communication, effective decision-making, and conflict resolution between internal teams and external partners; lead Joint Steering Committees.
- Act as primary liaison between internal teams and key stakeholders at academic institutions and industry partners.
- Oversee compliance with contractual obligations, milestones, and deliverables; work with Legal and Finance for contract amendments or renewals.
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