United States only“Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor. Mineralys is headquartered in Radnor, Pennsylvania. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn, Twitter and Bluesky”
Mineralys is a fully remote company.
Digital Center of Excellence Project Manager
The Project Manager is responsible for leading the planning and delivery of enterprise systems implementation projects across Mineralys, from initiation through deployment and operational transition. This role owns end‑to‑end project execution across the System Development Lifecycle (SDLC), coordinating cross‑functional teams, vendors, and stakeholders to ensure systems are delivered on time, within scope, compliant with regulatory expectations, and ready for adoption.
Operating within a regulated life sciences environment, the Project Manager ensures projects align with IT governance, architecture, cybersecurity, data integrity, and electronic records requirements while supporting business objectives and inspection readiness.
Key Responsibilities
End‑to‑End IT Project Delivery
- Lead systems implementation projects across the full SDLC, including requirements definition, solution design, configuration, integration, testing, deployment, and transition to operations.
- Develop and maintain integrated project plans, timelines, risks, and dependencies to support successful delivery and go‑live readiness.
- Own execution quality, issue resolution, and progress tracking to ensure predictable, well‑managed outcomes.
Cross‑Functional & Vendor Leadership
- Manage cross‑functional project teams spanning IT, Quality, business functions, and external vendors.
- Partner closely with business and system owners to translate operational needs into clear system requirements and implementation plans.
- Coordinate vendor delivery, ensuring alignment to scope, schedule, quality expectations, and Mineralys standards.
Compliance, Validation & Inspection Readiness
- Ensure system implementations comply with applicable regulatory, data integrity, and electronic records requirements (e.g., GxP, SOX, 21 CFR Part 11), where applicable.
- Coordinate Computer System Validation (CSV), SOX, or other compliance activities in partnership with system owners, business owners, and Quality.
- Maintain appropriate project and system documentation to support audits and inspections.
IT Governance & Enterprise Standards
- Ensure projects align with established IT governance, architectural principles, cybersecurity requirements, and data management standards.
- Support user adoption, training readiness, and operational handoff to ensure systems deliver sustained business value.
- Contribute to the development and continuous improvement of IT project delivery practices, tools, and frameworks across the enterprise.
Skills and Attributes
- Strong enterprise IT project leadership with the ability to operate effectively in a matrixed, cross‑functional environment.
- Structured, disciplined approach to planning, execution, risk management, and delivery.
- Ability to translate complex technical and regulatory requirements into clear execution plans.
- Strong communication and stakeholder management skills, including comfort engaging with senior leaders.
- Detail‑oriented, with a focus on quality, compliance, and inspection readiness.
- Adaptive and pragmatic, able to operate effectively in fast‑paced, evolving environments.
Qualifications
- Bachelor’s degree required; advanced degree preferred.
- Minimum of 3-5 years of IT project management experience, including enterprise software or SaaS implementations.
- 3+ years of experience in biotechnology, pharmaceutical, medical device, or other regulated life sciences environments.
- Demonstrated experience delivering systems subject to GxP, SOX, 21 CFR Part 11, or similar regulatory frameworks.
- Strong working knowledge of SDLC practices for enterprise or SaaS system implementations.
Travel
- This position requires up to 25% travel. Frequently travel is outside the local area and overnight.
This position is eligible for standard Company benefits including medical, dental, vision, time off and 401K, as well as participating in Mineralys incentive plans are contingent on achievement of personal and company performance. Actual compensation may vary from posted hiring range based on geographic location, work experience, education, and/or skill level.
AU, CA + 4 more