Job DescriptionReporting 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.
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.
Qualifications- 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 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.
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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