Alkermes · 5 days ago
Vice President, Head of Life Cycle Management
Greater Boston
Full-time
Onsite
Director/Executive
$360K/yr - $420K/yr
15+ years expAlkermes is a fully-integrated, global biopharmaceutical company focused on developing medicines for complex psychiatric and neurological disorders. The VP, Head of Life Cycle Management will lead the lifecycle management strategies for marketed products and pipeline programs, collaborating with cross-functional partners to ensure effective data generation and regulatory compliance.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Lead the efforts to collaborate with key cross-functional partners to define and implement comprehensive lifecycle management strategies for our marketed products and pipeline programs
Analyze and interpret scientific data, disease/treatment landscape, and external stakeholder evidence to identify challenges, opportunities, and strategic imperatives to communicate and demonstrate our portfolio value
Develop and execute data generation plans consistent 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 our 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 key 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 on the startup and monitor the progress of LCM studies
In collaboration with the clinical operations team, oversee the operational execution to ensure that the 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 that standard operating procedures (SOP) for Clinical Development facilitate the development of effective clinical research protocols and are compliant with clinical/medical and industry standards
Qualification
Required
MD with strong track record of minimum of 15 years of relevant biopharmaceutical industry experience required, at least 5 years of which should be 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 successfully filing sNDA programs
Operational experience of building and managing a team overseeing LCM studies
Highly motivated self-starter who can work independently, manage complex issues, and relate to multiple internal and external stakeholders
Experience working in a highly matrixed team environment and ability to lead through influence people across the organization and at all vertical levels
Proven record of problem solving, excellent communication skills (written and verbal), and experience interacting with and presenting to senior management and key external stakeholders
Experience building and managing teams and developing others
Working knowledge of regulatory and compliance requirements
Preferred
Sleep/Neuroscience/Psychiatry therapeutic experience is a benefit, as is relevant clinical care experience
Benefits
In addition, this position is eligible for an annual performance pay bonus.
Alkermes offers a competitive benefits package.
Company
Alkermes
Alkermes is a biotechnology company that develops, manufactures and commercializes medicines for the treatment of chronic diseases.
1001-5000 employees
H1B Sponsorship
Alkermes has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (32)
2024 (20)
2023 (21)
2022 (14)
2021 (27)
2020 (22)
Funding
Current Stage
Public CompanyTotal Funding
$250MKey Investors
Primecap Management
2017-11-20Post Ipo Equity
2014-01-13Post Ipo Equity· $250M
2011-09-16IPO
Leadership Team
Craig Hopkinson
EVP, Research and Development, CMO
Recent News
2026-01-24
2026-01-20
Company data provided by crunchbase