The VP, Head of Life Cycle Management is a highly visible and business-critical role that involves understanding business strategies and drivers, translating them into data generation plans, and collaborating with cross-functional partners.
Requirements
- Lead lifecycle management strategies for marketed products and pipeline programs
- Analyze and interpret scientific data, disease/treatment landscape, and external stakeholder evidence
- Develop and execute data generation plans, including leading Phase IIIB/Phase IV and investigator-initiated research
- Manage post-approval regulatory activities, including sNDA submissions
- Contribute to regulatory interactions, ensuring strategic alignment and scientific rigor
- Develop and oversee global expanded access programs and plans for pipeline products
- Partner with Scientific and Medical Communications team on plan, review, and approve publications and scientific content
- Identify and develop collaborative relationships with key investigators, and key thought leaders globally
- Represent the company externally within clinical and pharmaceutical industry forums and professional associations
- Develop and lead a high-performing LCM team to execute on startup and monitor progress of LCM studies
- Oversee operational execution to ensure that programs meet their timelines, budgets, and quality standards
- Manage study and departmental budgets in collaboration with project management and finance teams; ensure administrative compliance
- Ensure standard operating procedures (SOP) for Clinical Development facilitate the development of effective clinical research protocols and are compliant with clinical/medical and industry standards
Benefits
- Generous Paid Time Off
- 401k Matching
- Retirement Plan
- Visa Sponsorship
- Four Day Work Week
- Generous Parental Leave
- Tuition Reimbursement
- Relocation Assistance