Sr. Medical Director/Medical Director, Global Safety Officer

Sr. Medical Director/Medical Director, Global Safety Officer The Sr. Medical Director/Medical Director, Global Safety Officer (GSO) will work closely with the DSPV leadership team to provide strategic safety oversight for assigned investigational and/or marketed products within the Alkermes Neuroscience portfolio. Reporting to the Head of DSPV, the GSO will play a visible role in safety advisement across company-wide forums and initiatives. Responsibilities Provide medical leadership within Drug Safety Benefit‑Risk Management. Accountable for therapeutic area/product safety oversight and strategies, including: Strategic advisement on clinical development plans and protocol design. Safety content for investigator brochures and informed consent forms; support DSMBs and study‑specific safety review forums. Regulatory safety input for INDs, labeling, clinical overview documents, briefing books, and annual reports. Content and management of Risk Management Plans and overall risk minimization strategies. Preparation of aggregate safety reports (DSUR, PSUR, PADER) and benefit‑risk evaluation. Design of post‑approval safety studies; contribution to publications, HEOR and epidemiology projects. Serve as the safety expert for DSPV, cross‑functional teams and leadership on safety findings, regulations, and industry standards. Lead product safety surveillance and signaling activities for assigned product(s) in collaboration with DSPV staff. Ensure timely assessment, investigation, and documentation of signaling activities. Effectively communicate and respond to product safety queries from ethics committees and regulatory authorities. Lead product benefit‑risk assessment and presentation to the Safety Committee, and implement action plans as needed. Represent Drug Safety and Pharmacovigilance in assigned program teams, clinical development teams, and study‑management teams. Qualifications MD or MD/PhD required. Minimum 4+ years’ experience for the Medical Director role; 7+ years for the Sr. Medical Director role in Drug Safety & Pharmacovigilance or related clinical experience. Preferred Requirements Prior experience in patient care, early clinical development, or clinical pharmacology. Safety/medical experience in the Neuroscience therapeutic space. Strategic and critical‑thinking skills. Leadership and collaboration within a matrixed, dynamic organization and across functions and geographies. Excellent oral and written communication, organizational skills, and sense of urgency. Knowledge of pre‑ and post‑marketing US and EU regulations. Proven 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. Compensation & Benefits Annual base salary range: $254,000 to $289,000. Eligible for an annual performance pay bonus and a competitive benefits package. See our careers website for full details. Working Environment The position operates in a hybrid model: 60% time in the office and 40% remote, requiring on‑site presence at our Waltham, MA office at least three days per week. Fully remote is not eligible. Company Overview Alkermes applies deep neuroscience expertise to develop medicines for psychiatric and neurological disorders. With a global biopharmaceutical presence, we are committed to pursuing great science and fostering an inclusive workplace. EEO Statement 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. #J-18808-Ljbffr