The Director level clinical pharmacologist/pharmacokineticist in the Clinical Pharmacology and Translational Medicine group plays a central role in both clinical development and in support of nonclinical development at company.
The Director, Contract Operations, is responsible for leading and continuing the development of the Contract Operations function for a growing commercial organization with two approved products (one for the treatment of addiction and another for the treatment of schizophrenia) and a portfolio of pipeline product candidates focused on CNS diseases.
The Director will lead a team of DSPV Specialists and Operation managers and will play a visible and pivotal role in growing this function within Alkermes Drug Safety and Phamacovigilance (DSPV). This individual will be accountable for the processes and performance of all case processing activities, including procedures and tools for managing effective and compliant submissions for all investigational and marketed products.
Develop business cases, secure approval & resources required to pursue the development of new capabilities & investments, manage the development of requirement specifications related to these, and charter & guide the efforts of matrixed project teams in their implementation.
The Director of PV Systems and Analytics will manage and direct all aspects of the drug safety database application and analytics. This individual will play a visible and pivotal role in further growing the Safety Systems function including analytics within the Drug Safety and Pharmacovigilance (DSPV) organization.
Lead Talent Acquisition recruitment for the Commercial organization including Sales, Managed Markets, Sales Operations and Analytics, Marketing, Forecasting, Trade, Commercial Effectiveness, and/or Government Affairs and Policy.
Provide guidance on complex use cases involving personally identifiable information and other data, taking into account consent, notice, use, transparency and systems controls. Work with IT, Security and other teams to ensure incorporation of privacy by design approach into Biogen data processing procedures.