Vice President, Head of Life Cycle Management
Vice President, Head of Life Cycle Management Reporting directly to the Head of Medical Affairs, the VP, Head of Life Cycle Management (LCM) is a highly visible and business‑critical role at Alkermes. The role is tasked with understanding the business strategies and drivers underlying our medicines for the treatment of serious mental illness, sleep disorders and our emerging neuroscience pipeline and translating those drivers into data generation plans across our programs and disease areas of interest. The VP will need to effectively collaborate and communicate with colleagues within Medical Affairs and key cross‑functional partners (e.g., Commercial, Clinical Development, Clinical Operations, Regulatory Affairs, Safety, Biostatistics, Program Management, Government Affairs, Business Development), and frequently represent the function to senior management and the company to healthcare professionals. This position is based in Waltham, MA. Responsibilities Lead the efforts to collaborate with key cross‑functional partners to define and implement comprehensive life‑cycle 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 approval of 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. Collaborate with the clinical operations team to oversee operational execution ensuring that programs meet timelines, budgets, and quality standards. Manage study and departmental budgets in collaboration with project management and finance teams; ensure administrative compliance. Ensure SOP for Clinical Development facilitate effective clinical research protocols and are compliant with clinical/medical and industry standards. Qualifications MD with a strong track record of minimum 15 years of relevant biopharmaceutical industry experience, 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 successfully filing sNDA programs. Operational experience building and managing teams 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 working in a highly matrixed team environment and ability to lead through influence people across the organization at all vertical levels. Proven record 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. Travel Willingness/ability to travel up to 25% domestically. International travel may be required. The annual base salary for this position ranges from $360,000 to $420,000. In addition, this position is eligible for an annual performance‑pay bonus. Alkermes offers a competitive benefits package. Additional details can be found on our careers website: www.alkermes.com/careersworking-here. About Us Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult‑to‑treat psychiatric and neurological disorders. A fully‑integrated, global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients. Beyond our mission, we actively foster a culture of diversity, inclusion and belonging. We are proud to be recognized as an employer of choice, being certified as a Great Place to Work in the U.S. in 2024, honored as a Healthiest Employer in Ohio and Massachusetts in 2023, best places for working parents, and recipients of the Bell Seal at the Platinum level for Workplace Mental Health. Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee. Alkermes complies with all work authorization and employment eligibility verification requirements. J-18808-Ljbffr
