Key Responsibilities
Clinical Supply Strategy
- Lead development and execution of investigational and commercial global supply strategies for early and late-stage development programs.
- Partner with Pharmaceutical Sciences Project Team (PSPT) and Co-Development Team (CDT) to identify and address logistical and regulatory issues.
- Serve as a core study team member; provide operational knowledge and lead strategy discussions to align investigational product (IP) needs with protocol and operational requirements.
- Proactively anticipate changes based on countries, sites, enrollment, randomization configuration, and protocol requirements.
- Partner with the Clinical Supply Team (CST) to develop clinical supply solutions (packaging, blinding, distribution) that meet study needs and ensure patient compliance and safety.
- Identify supply risks, develop mitigation strategies, and create contingency plans.
- Manage clinical trial drug supply budget; communicate forecasts and changes to study teams and GCS partner lines.
- Maintain project information in GCS and PharmSci project tracking systems.
- Ensure site and patient focus with quality compliance across PharmSci and GCS.
- Provide required input for audits and regulatory inspections and support inspection readiness.
- Participate on limited duration teams and continuous improvement projects.
Matrix Team Leadership
- Matrix team lead for the MedSci GCS Clinical Supplies Team (CST); provide broad consulting on clinical drug supply.
Basic Qualifications
- Bachelor’s degree + 5 years; OR Master’s + 3 years; OR PhD + 0+ years; OR Associate’s + 8 years; OR High school + 10 years.
- Ability to manage large, complex clinical development programs.
- Lead business development activities/acquisitions related to clinical programs.
- Knowledge/experience in GMP (cGMP) and GCP (GxP) environments.
- Understanding of pharma quality and regulatory framework.
- In-depth experience managing multiple clinical studies in parallel.
- Experience leading/delivering in a matrix team environment.
- Working knowledge of MS Office and AI tools (e.g., Copilot).
- Experience in drug development/clinical study design (e.g., telerandomization) and pharmaceutical manufacturing/packaging/labeling/distribution and import/export.
- Management of multidisciplinary teams (work measurement, negotiation, conflict management, process improvement, project management).
- Ability to develop/communicate execution plans and gain stakeholder support.
- Experience managing change in dynamic, complex environments.
- Experience with budgeting and forecasting.
Nice to Have Qualifications
- Relevant pharmaceutical experience.
- Operational experience across diverse business portfolios (e.g., biopharmaceuticals, consumer products, other industries).
- Past oral presentations at conferences/large audiences.
- Breadth of leadership experience (influence/collaboration, coaching, guiding others to meaningful outcomes and business impact).
Work Location
- Hybrid
Benefits
- Eligible for participation in Pfizer’s Global Performance Plan (bonus target 15% of base salary) and share-based long-term incentive program.
- 401(k) with Pfizer matching contributions; additional Pfizer retirement savings contribution; paid vacation/holidays/personal days; paid caregiver/parental and medical leave; health benefits (medical, prescription drug, dental, vision).
Application Instructions
- Candidates must be authorized to work in the U.S.; U.S. work visa sponsorship (e.g., TN, O-1, H-1B) is not available.