Senior Medical Director - Medical Director, Global Safety Officer Location: Waltham United States Job Description: The Sr. Medical Director/Medical Director, Global Safety Officer (GSO) will work closely with the DSPV leadership team and will provide strategic safety oversight for the assigned investigational and/or marketed products, for the Alkermes Neuroscience portfolio. Reporting to the Head of DSPV, the GSO will serve in a visible role in providing safety advisement in several company-wide forums and initiatives. Demonstrated prior career success as a product safety physician, having led clinical and post-marketing programs as the Safety lead, working in close partnership with cross-functional teams. This individual will be responsible for collaborating and working effectively with key stakeholders and keeping the DSPV leadership informed of evolving safety issues and strategies. Key success factors also include building high trust, accountability and demonstrating a sense of urgency in leading critical projects, showing the capability to work either independently or collaboratively in a matrixed environment, and to be able to effectively communicate with varied stakeholders. Responsibilities: Provide medical leadership within Drug Safety Benefit-Risk Management - Accountable for therapeutic area/product safety oversight and strategies/activities including (but not limited to): - Strategic advisement on clinical development plans and clinical protocols design - Responsible for developing safety content of IB and ICFs and support of DSMBs or study-specific safety review forums for clinical programs - Strategic safety input for regulatory documents, including benefit-risk content within the Clinical Overview documents, Briefing Books, INDs, Annual reports, labeling etc. - Responsible for the content of any Risk Management Plan, and for the overall risk management and minimization strategies for assigned programs/portfolio, in alignment with internal stakeholders - Responsible for the content of aggregate safety reports (i.e., DSUR, PSUR, PADER) including assessment of benefit-risk evaluation - Advisement on the design of post-approval safety studies; Safety SME and contributor for publications, HEOR and epidemiology projects - Be a resource and the safety expert to DSPV, cross-functional teams and leadership, on matters of safety findings, quality issues, safety regulations and processes, industry standards, and other relevant topics relating to safety strategy and execution - Medical and Safety expertise towards Business Development/Due Diligence activities for Alkermes Neuroscience portfolio - The Global Safety Officer (GSO) will lead safety oversight for assigned investigational and/or marketed products, including: - Lead product safety surveillance and signaling activities for assigned product(s) in collaboration with DSPV staff - Acquire a deep understanding of the disease process and assigned product(s) efficacy and safety profile including a working knowledge of other products in the class and therapeutic space - Ensure that routine signaling activities, assessment, and investigation are completed and documented in a timely manner - Ability to effectively communicate and respond to product safety queries from all sources including ethics committees and regulatory authorities - Lead product benefit-risk assessment and presentation to the Safety Committee and any needed actions to update patient safety information - Lead Drug Safety and Pharmacovigilance representation in the assigned program team and clinical development team and respective study management teams Qualifications: - MD or MD/PhD required - Minimum of 4+ years of experience required for the Medical Director role, of 6+ years for the Sr. Medical Director role, in Drug Safety & Pharmacovigilance and/or other relevant clinical experience Preferred Requirements: - Prior experience in patient care, clinical development (including early clinical), and/or knowledge of clinical pharmacology desirable - Safety/medical experience in the Neuroscience therapeutic space is highly desirable - Strategic and critical thinking skills - Leadership as well as the ability to perform effectively in a matrixed and dynamic environment, with the ability to collaborate across functions and geographies - Excellent communication (oral and written) as well as organizational skills. - Sense of urgency and accountability for both individual and team-owned work products - Knowledge of pre- and post-marketing US and EU regulations In addition to the requirements above, the Sr. Medical Director level requires: - Demonstrated ability to lead safety strategy across global clinical programs and post-marketing settings - Experience representing DSPV in regulatory inspections and cross-functional governance forums - Advanced understanding of global pharmacovigilance regulations and benefit-risk frameworks - Experience contributing to scientific publications and external presentations on safety topics Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home. This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. This role is not eligible for fully remote work. The annual base salary for this position ranges from $285,000 to $320,000. 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 #LI-MB1 Why join Team Alkermes? Alkermes applies its decades of deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we seek to make a meaningful difference in the way people manage their diseases. We have a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy, and a pipeline of clinical and preclinical candidates in development for various psychiatric and neurological disorders. We are proud to have been recognized as an employer of choice by many national organizations. In 2024 and 2025, we were certified as a Great Place to Work in the U.S. and named one of Massachusetts' Top Places to Work by the Boston Globe, a Best Place to Work in Greater Cincinnati by the Cincinnati Business Courier and recognized as a Best Place to Work in BioPharma by Fortune Magazine. 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.

Role Description As a Medical Director at ICON, you will thrive in a fast-paced environment driven by collaboration, partnership, and accountability. Key Responsibilities: - Medical Support: Guide ICON project teams on clinical issues, ensuring studies adhere to the highest ethical principles and legal standards. - Expertise & Interaction: Provide therapeutic and drug development expertise, interacting with sponsors and investigative sites on protocol medical issues. - Presentations & Documentation: Contribute to investigator meeting presentations, review study documentation, oversee safety data reviews, and support Business Development efforts. Qualifications - Medical Degree & Board Certification in Neurology: Essential. - Experience: Minimum of 2 years in Clinical Research within academia, pharmaceutical, biotech, or other CRO industries. - Skills: Strong ability to review and evaluate clinical data with excellent oral and written communication skills. Benefits - Competitive base salary and performance related incentives. - Health and wellbeing programmes including medical, dental, and vision coverage where applicable. - Retirement and pension plans. - Life assurance and disability coverage. - Employee assistance programmes and wellbeing resources. - Learning and development opportunities through structured training and career pathways. - Benefits may vary depending on role and location.

• Lead, develop, direct, and implement clinical and non-clinical activities that impact health care quality, cost, and outcomes. • Direct the utilization review process and oversee the quality of utilization determinations, including case reviews, peer to peer provider discussions, and appeals. • Ensure compliance with clinical goals through monitoring of care management performance. • Oversee application of medical policies to ensure the appropriate and most cost-effective medical care is received, and for the day-to-day management of medical management staff. • Recommend changes and enhancements to current managed care, review guidelines, and clinical criteria based on extensive knowledge of health care delivery systems, utilization methods, reimbursement methods, and treatment protocols. • Develop, implement, and interpret medical policy including medical necessity criteria, clinical practice guidelines, and new technology assessments. • Lead clinical staff in the coordination of quality care. • Provide clinical expertise and business direction in support of medical management programs through participation in clinical team activities. • Analyze policy/procedure/workflows on case management and utilization management for redesign and efficiency opportunities. • Act as lead clinical liaison to select plan sponsors including reviewing clinical trends, exploring new clinical strategies, handling escalations, and supporting sales and renewal activities as needed. • Support and train SMDs and MDs on such activities. • Identify and advance new affordability initiatives for the Commercial line of business, not limited to medical policy and utilization review activities. • Monitor KPIs and trends to understand value and opportunities and expand Aetna's medical management programs to address member needs across the continuum of care. • Provide clinical support for UM/CM/Appeals complex or escalated cases as appropriate. • Participate in an on‑call rotation, including occasional weekend coverage.

Role Description The Senior Staff Medical & Scientific Affairs Liaison – Cardiometabolic drives important initiatives in KOL engagement, advisory boards, research, publications, medical education, and field intelligence between our Cardiometabolic MSA team and the academic/non-academic cardiometabolic community. This is a vital role that requires a blend of strategic understanding and expertise in Medical Affairs/Clinical Affairs to foster advancements in cardiometabolic diagnostics and support the medical community. - Develop and cultivate strong relationships with key opinion leaders (KOLs) and healthcare professionals. - Identify unmet needs/scientific gaps in medical research and clinical practice paradigms. - Collaborate cross-functionally with internal partners to deliver field and medical insights. - Participate in and/or drive special projects including: - Voice of customer events - Physician initiated clinical studies and off-label conversations - Internal and external education - Publication planning and execution - Bridge the gap between Beckman Coulter and our cardiometabolic customers by maintaining detailed knowledge of our product platforms. - Understand business and strategy objectives and goals. - Stay updated on current literature and data in the cardiometabolic space. This position reports to the Associate Field Director, Medical & Scientific Affairs – Cardiometabolic and is part of the Medical & Scientific Affairs organization, a team of medical specialists dedicated to all medical aspects of safe and effective therapeutic areas. The Beckman cardiovascular test portfolio enables better patient outcomes for those afflicted with cardiometabolic disease. This role may be fully remote in designated territory, working remotely to cover a global business area. - Support the development and implementation of strategic engagement plans to establish and maintain relationships with KOLs, interventionalists, operating room staff, and relevant medical societies in the cardiometabolic field. - Support clinical studies and research initiatives by providing scientific and technical expertise and maintaining open lines of communication to the external KOLs and authors. - Train MSL team on research funnel opportunities and how to position these with the clinical community. - Act as a scientific authority in cardiometabolic, providing medical, scientific, and practical / hands-on education to internal and external collaborators. - Communicate & streamline complex scientific information effectively to the broader MSL organization. - Stay up to date with the latest scientific research, medical publications, and emerging trends in cardiometabolic. - Own the preparation of materials needed to deliver presentations on the science supporting the portfolio. - Participate in scientific symposia, conferences, and educational programs to improve awareness and understanding of the platforms. - Provide training and education to internal teams, including Sales and Marketing, to ensure a deep understanding of scientific message. Qualifications - Bachelor’s degree with 14+ years of experience (or Master’s/Doctoral degree with 12+ years of experience in the healthcare industry; substantial understanding of relevant therapeutic area required). - Minimum of 5 or more years of experience in a Medical Affairs/Medical Science liaison/Clinical Practice preferred. - Extensive knowledge of cardiometabolic diagnostics and techniques preferred. - Strong understanding of clinical research methodologies, regulatory guidelines, and medical terminology. - Proven track record to establish and maintain relationships with KOLs, interventionalists, and other healthcare professionals. - Excellent interpersonal, communication and presentation skills, with the ability to effectively communicate complex scientific concepts to both scientific and non-scientific audiences. Requirements - Ability to travel a minimum of 20-25% of the time (domestic and international). - Must have a valid driver’s license with an acceptable driving record. Benefits - Comprehensive package of benefits including paid time off, medical/dental/vision insurance, and 401(k) to eligible employees. - Eligible for bonus/incentive pay. - Flexible, remote working arrangements for eligible roles.