The Director/Sr Director, Project Management or Project Leader will be responsible for managing cross-functional product development planning and coordinating the strategic and operational execution of a portfolio of clinical development program(s) while adhering to budget, scope, and schedule requirements. A key focus of this position will be the support of ALPN-101, in addition to other programs in the Alpine portfolio.
- 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 with coordination of 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 project management experience in a pharmaceutical/biotech setting
- Successful experience in oversight of global clinical programs and lifecycle required; experience in systemic lupus erythematosus or related indications, and drug development thru BLA/NDA and ex-US equivalent(s) and commercialization, as well as alliance management, strongly desired
- Bachelor’s degree or equivalent in a science or health-related field
- PMP and demonstrated project management excellence
- 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), FSA, and generous paid time off benefits.
Alpine is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Alpine is also committed to compliance with all fair employment practices regarding citizenship and immigration status.