Executive Medical Director, Drug Safety And Pharmacovigilance

Overview: The Executive Medical Director serves as a senior member of the DSPV leadership team, accountable for the management, mentoring and development of assigned benefit-risk management staff as well as serving as a global safety officer for assigned investigational and/or marketed products.

Reporting to the Head of DSPV, the Executive Medical Director will also serve in a visible role in providing safety leadership and advisement in several company-wide forums and initiatives. The successful candidate will have demonstrated prior career success as a product safety physician and managing/ developing individuals and highly effective teams. This leader will be expected to roll-up their sleeves and help do the work in addition to managing direct reports.

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 and to be able to effectively communicate with varied stakeholders both verbally and in writing. The individual who assumes this position will interact with multiple levels of management within Alkermes, external stakeholders in the medical community, as well with global regulatory authorities. Responsibilities Key Responsibilities Provide medical leadership and management/development to direct reports within Drug Safety Benefit-Risk Management Accountable for therapeutic area/product safety oversight and strategies/activities performed by direct reports including:

Strategic advisement on clinical development plans, design of clinical protocols Responsible for safety content of IB and ICFs and support of DSMBs Analysis strategy for Integrated Summary of Safety (ISS) and benefit-risk content within the Clinical Overview documents associated with regulatory filings Responsible for the content of Risk Management Plan/ REMS as required Responsible for content of aggregate safety reports (i.e., DSUR, PSUR) including assessment of benefit-risk Advisement on the design of post-approval safety studies In role as a Global Safety Officer for assigned investigational and/or marketed products: 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: Senior member of the Drug Safety leadership team:

Responsibilities include: advisement, employee development, design and implementation of department goals, policies and long-term strategies Senior medical leadership representative from Drug Safety with highly visible role in protocol review committees and other company-wide forums and initiatives. Medical and Safety expertise towards Business Development/Due Diligence activities for Alkermes Neuroscience portfolio. Qualifications Basic Requirements:

MD, or MD PhD, or MD MPH required Minimum of 14 years of experience in Drug Safety/Benefit Risk Management expertise 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 High emotional intelligence with experience managing and developing direct reports as well as highly effective teams Demonstrated strategic and critical thinking skills Demonstrated leadership as well as the ability to perform effectively in a matrixed and dynamic environment, ability to lead and collaborate within complex organization, across functions and geographies; to work in an entrepreneurial culture Excellent communication (oral and written) as well as organizational skills Demonstrated sense of urgency and accountability for both individual and team-owned work products Knowledge of pre- and post-marketing US and EU regulations Ability to work 3 days per week in Waltham, MA office About Us Alkermes plc is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. The company 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 neurological disorders.

Headquartered in Dublin, Ireland, Alkermes has a research and development center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant 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 class protected by 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.