Medical Director, DSPV
Alkermes, Inc. is the U.S. operating company of Alkermes plc, a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to research, develop and commercialize, both with partners and on its own, pharmaceutical products that are designed to address unmet medical needs of patients in major therapeutic areas. Alkermes has a diversified portfolio of marketed products focused on central nervous system disorders such as addiction and schizophrenia and a pipeline of product candidates in the fields of neuroscience and oncology. Headquartered in Dublin, Ireland, Alkermes has a research and development ("R&D") center in Waltham, Massachusetts; an R&D and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio.
The following position is for Alkermes, Inc.
The Medical Director serves as the therapeutic area lead for all assigned investigational and/or marketed products in pharmacovigilance and risk management activities. This may also include serving as a global safety officer for one or more assigned investigational and/or marketed products. The candidate will have a visible role in providing safety leadership and advisement in several company-wide forums and initiatives.
The successful candidate must have demonstrated prior success as a product safety physician or similar role. . He/she will have a high EQ with a passion for Drug Safety and managing/developing individuals and highly effective teams. Key success factors 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. Overseeing safety scientists who are responsible for identification of safety signals, signal investigation and the proactive management of the benefit-risk profile for assigned products, the role plays a critical leadership role in to program team through the product life-cycle working in close collaboration with Research, Pre-clinical Safety, Clinical Development, Medical Affairs, Regulatory Affairs and other functions in product life-cycle management.
The successful candidate will have demonstrated accountability and 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 either verbally or in writing with impact.
Position will report to the Executive/Senior Medical Director, Drug Safety and Pharmacovigilance.
It is expected that the global safety officer will establish a high level of trust and collaboration with cross-functional counterparts in carrying out these activities:
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.