PV Operations Director: Scale for Commercial Launch

Compass Therapeutics Inc.; Boston (MA); On-site; USD 175,000 - 250,000; Full time

Benefits offered by this job

Equity participation

401(k) with company match

Comprehensive compensation & benefits

Job summary

Compass Therapeutics Inc. is seeking an Associate Director/Director of Pharmacovigilance Operations to lead the transition from clinical to commercial PV activities.

This role reports to the VP of Drug Safety and PV and is onsite four days per week at the Brighton, MA office. You will drive PV infrastructure scale-up, governance, and vendor management to ensure readiness for NDA/MAA submissions and commercial launch.

Qualifications

• Bachelor’s degree in nursing, pharmacy, or related healthcare field required; MSN or advanced degree preferred.
• 8+ years of progressive clinical drug safety/pharmacovigilance experience; biotech/pharma industry experience.
• Director-level candidates require 12+ years of experience including leadership roles.

Responsibilities

• Ensure PV objectives are achieved with timelines, quality standards, and commercial readiness.
• Lead scale-up of PV operations infrastructure for transition from clinical to commercial stage.
• Oversee PV vendor governance, QA, audits, and inspection readiness for commercial readiness.
• Design and maintain post-market PV system and Quality System for NDA/MAA readiness.
• Lead safety evaluation, benefit-risk assessment, and PV compliance activities.

Skills

PV operations

Vendor management

Regulatory inspections

Pharmacovigilance

Risk management

Cross-functional collaboration

Education

Bachelor’s degree in nursing/pharmacology or related field

MSN or advanced degree preferred

Tools

Argus/ArisG

Medidata Rave/InForm

Job description

Compass Therapeutics Inc. is seeking an Associate Director/Director of Pharmacovigilance Operations to lead the transition from clinical to commercial PV activities.

This role reports to the VP of Drug Safety and PV and is onsite four days per week at the Brighton, MA office. You will drive PV infrastructure scale-up, governance, and vendor management to ensure readiness for NDA/MAA submissions and commercial launch.