Vice President, Head of Life Cycle Management

Role Summary

Reporting directly to the Head of Medical Affairs, the VP, Head of Life Cycle Management (LCM) is a highly visible and business-critical role tasked with understanding the business strategies and drivers underlying our medicines for serious mental illness, sleep disorders, and our emerging neuroscience pipeline, and translating those drivers into data generation plans across programs and disease areas of interest. This individual will collaborate with Medical Affairs and cross-functional partners, and frequently represent the function to senior management and healthcare professionals. This position is based in Waltham, MA.

Responsibilities

• Lead collaboration with cross-functional partners to define and implement comprehensive lifecycle management strategies for marketed products and pipeline programs.
• Analyze scientific data, disease/treatment landscape, and external stakeholder evidence to identify challenges, opportunities, and strategic imperatives to demonstrate portfolio value.
• Develop and execute data generation plans aligned with program goals, 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 the Scientific and Medical Communications team on plan, review, and approve publications and scientific content.
• Identify and develop collaborative relationships with key investigators and thought leaders globally; attend and oversee clinical advisory boards and investigator meetings.
• Collaborate with Health Outcomes Research and Patient Advocacy to ensure a patient-centric approach.
• Represent the company externally within clinical and pharmaceutical industry forums and professional associations.
• Develop and lead a high-performing LCM team to execute startup and monitor progress of LCM studies.
• Oversee operational execution with the clinical operations team to ensure programs meet timelines, budgets, and quality standards.
• Manage study and departmental budgets in collaboration with project management and finance teams; ensure administrative compliance.
• Ensure SOPs for Clinical Development facilitate effective clinical research protocols and compliance with standards.

Qualifications

• MD with a minimum of 15 years of relevant biopharmaceutical industry experience required, including at least 5 years managing LCM studies within clinical development and/or medical affairs.
• Experience running and managing Phase IIIb/IV research programs and end-to-end LCM studies.
• Proven track record of successfully filing sNDA programs.
• Operational experience building and managing a team overseeing LCM studies.
• Sleep/Neuroscience/Psychiatry therapeutic experience is a benefit, as is relevant clinical care experience.
• Highly motivated self-starter who can work independently, manage complex issues, and relate to multiple internal and external stakeholders.
• Experience in a highly matrixed team environment and ability to lead through influence across the organization and all levels.
• Proven problem-solving abilities, excellent written and verbal communication skills, and experience presenting to senior management and external stakeholders.
• Experience building and managing teams and developing others.
• Working knowledge of regulatory and compliance requirements.

Travel

• Travel up to 25% domestically; international travel may be required.