Group Manager, Product Development Operations

The Group Manager, PDO is accountable for end-to-end alignment of Arrowhead products from preclinical through commercial phases. This role leads assigned projects and provides leadership to cross-functional CMC teams from drug substance process development through delivery of clinical kits. Oversees internal and external CMC activities to ensure alignment with program timelines, quality standards, and regulatory requirements. Partners with external stakeholders, including CMOs and CROs.

Responsibilities:
- Act as primary point of contact for projects; facilitate communication across internal/external teams for CMC development, analytical, manufacturing, packaging, and labeling
- Maintain project status clarity and tailor communications for leadership and stakeholders/partners
- Manage budget, timeline, quality, and deliverables for each project and vendor
- Escalate risks, drive scenario planning, and present recommendations
- Maintain/expand project tracking tools (Smartsheet, Excel, Power BI)
- Analyze project metrics and prepare recommendations
- Interface with cross-functional teams (Chemistry, Engineering, Analytical, Quality) on partner development/manufacturing
- Track/manage/negotiate proposals and draft RFPs (with technical SME’s and Legal)
- Steer contract/supply/agreement alignment with SME’s, Sourcing & Supplier Management, Legal, and Finance
- Track vendor invoices and collaborate with Finance on payments
- Develop and maintain performance metrics for partners
- Lead meetings, vendor/partner visits, and conference calls; facilitate internal consensus/decisions
- Support business review meetings with vendors; support vendor management as needed
- Assist in CMC outsourcing budget development/review
- Coach/mentor direct reports; create training materials and support onboarding
- Collaborate with Alliance Management on partnership goals

Requirements:
- Bachelor’s in a scientific field (Chemistry, Chemical Engineering, Biochemistry, Biotechnology)
- 8+ years increasing responsibility in a pharmaceutical company, CMO or CRO (including direct report experience)
- 5+ years in project management managing clients/partners/vendors
- Knowledge of GLP, GMP, and regulatory guidance
- Strong MS Office skills (Outlook, Excel, PowerPoint, Word)
- Excellent verbal/written communication; matrix collaboration
- Detail-oriented, organized self-starter

Preferred:
- Master’s in related science field
- GLP/GMP lab or manufacturing experience
- Late-stage CMC development/commercialization experience
- Project Management Certification; ERP experience

Application instructions:
- Candidates must have current, valid authorization to work in the country where the role is located.