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Lead design, planning, execution, and quality oversight of clinical trial data management (Phase I-IV). Manage CROs and vendors, ensure EDC/eCRF/ CDM standards, support database locks/snapshots, collaborate with Biostatistics/Programming and other functions, and maintain regulatory-ready documentation for submissions.

The Associate Director of Contracts will manage the drafting, negotiation, and administration of various contracts within the biotech sector, ensuring compliance and facilitating communication between departments.

Lead TMF operations end-to-end, ensure inspection readiness, manage eTMF platform and vendors, develop TMF SOPs and training, monitor KPIs, oversee archiving and closeout, and supervise a team supporting clinical study TMFs.

Manage GXP document control within Veeva EDMS, maintain policies and version control, perform audits and data cleaning, ensure regulatory compliance (GCP/GLP/GMP), train staff on Veeva, collaborate cross-functionally, and identify process improvements.

Lead and build Apogee's strategic sourcing and procurement function: develop enterprise-wide sourcing frameworks, manage RFP/RFQ/RFI and contract negotiations, select and manage suppliers, conduct spend analysis, track procurement KPIs, ensure compliance and budget adherence, and partner cross-functionally with clinical, manufacturing, legal, and SG&A teams to drive cost-effective, high-quality supplier relationships.

The Associate Director will oversee competitive intelligence, support corporate strategy, and collaborate across functions to achieve business objectives, including business development efforts.

The Associate Director leads QC analytical testing, ensuring compliance with regulations, managing method validations, and collaborating on regulatory submissions.

Seeking an Associate Director of GMP Quality Assurance to lead QA activities for biologics manufacturing, maintain quality systems, and ensure compliance with regulations. Collaborate with teams to drive improvements and prepare for regulatory inspections.

The Director, Purification Development will manage CDMO processes for drug substance and product production, providing technical leadership and supporting clinical development across teams.

The Associate Director oversees CRAs managing CRO monitoring for clinical trials, ensuring compliance, performance, and process development while leading teams and managing training.