We are seeking a Director of Program Management to manage cross-functional product development planning and coordinating the strategic and operational execution of a portfolio of clinical development programs while adhering to budget, scope, and schedule requirements.
- Coordinate program planning and project management, including cross-functional resource planning and financial assessments.
- Work with team members from clinical development, nonclinical, and CMC groups to develop integrated timelines and execute cross-functional operational plans for the project/program while coordinating all respective deliverables.
- Create program and project budgets including pricing strategy and work with project team members to manage cost to budgets.
- Work with manufacturing (supply & CMC operations), clinical pharmacology, and clinical operations to develop clinical trial enrollment projections and study drug supply needs.
- Optimize information distribution and communication to cross-functional study teams.
- Develop and apply best practices in the planning, initiation, execution, and closing of projects.
- Lead risk assessment processes and review of mitigation plans across projects and programs.
- Manage and/or coordinate project vendors (e.g. clinical CRO, central laboratories, BDS and DP CMOs, toxicology CRO).
- Interact with finance, research and development, regulatory, and other relevant departments as appropriate.
- Accountable to company executive management regarding portfolio and project deliverables.
Desired Skills and Experience:
- At least 8 years of program management experience in a pharmaceutical/biotech setting. Successful experience in oversight of global clinical programs and lifecycle required.
- Experience thru BLA/NDA and ex-US equivalent(s) and commercialization strongly desired.
- Bachelor’s degree or equivalent in a science or health-related field
- PMP and demonstrated project management excellence
- Oncology and/or autoimmunity/inflammatory disease development experience desired
- Demonstrated success at clinical trial initiation through completion
- Demonstrated successful management of CROs, central laboratories, and CDMOs, including RFP processes and budgeting
- Thorough knowledge of ICH/GxP and appropriate regulatory guidelines
- Strong interpersonal and communication skills including attention to detail
Alpine team members enjoy competitive salaries, equity participation (stock options), and an excellent benefits package including health and life insurance, a 401(k), and generous paid time off benefits.