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. This 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. This individual 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.
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.
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
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 externalstakeholders
Experience working in a highly matrixed team environment and ability to lead through influence people across the organization and at all verticallevels
Proven record of problem solving, excellent communication skills (written and verbal), and experienceinteractingwithandpresentingtoseniormanagementandkeyexternalstakeholders
Experience building and managing teams and developingothers
Working knowledge of regulatory and compliancerequirements
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. Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package. Additional details can be found on our careers website: www.alkermes.com/careers#working-here
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Why join Team Alkermes?
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. Alkermes has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for various neurological disorders, including narcolepsy.
Beyond our important mission of developing medicines to address unmet patient needs, we actively seek to foster a culture of diversity, inclusion and belonging throughout our business. We strive to ensure that all voices are respected and valued, recognizing that our diversity of thought, background and perspective makes us stronger. We are proud to have been recognized as an employer of choice by many national organizations, including being certified as a Great Place to Work in the U.S. in 2024, honored as a Healthiest Employer in both Ohio and Massachusetts in 2023, a Best Place for Working Parents in 2023, and to have received the Bell Seal at the Platinum level for Workplace Mental Health by Mental Health America for three consecutive years (2021-2023).
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.
At Alkermes, we apply our deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. We have a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for neurological disorders. Our patient-inspired science, integrated research strategy, sophisticated development capabilities and specialized commercial infrastructure enable us to pursue the development and commercialization of innovative new medicines, including those for people with conditions that have traditionally been overlooked or stigmatized.
Our greatest strengths at Alkermes are our people and our inherent empathy for patients, families and caregivers. Neurological and psychiatric disorders strike people at the core of who they are and impact many facets of their lives. We work with urgency to develop new treatment options for people living with these conditions.
Beyond our important mission of developing medicines, we believe it is our responsibility to take a holistic approach as we seek to support patients, caregivers and broader impacted communities. We remain committed to patient engagement, responsible and sustainable operations, and equitable access to quality treatment.
Headquartered in Ireland, Alkermes also has a corporate office and research and development center in Massachusetts and a manufacturing facility in Ohio.
See our Community Guidelines: https://www.alkermes.com/social-community-guidelines
