Senior Director, Translational Medicine

This is a high impact leadership position on the Translational Medicine (TM) team, part of the Pharmaceutical and Early Clinical Development department. It is a high visibility role that will frequently interact with leaders across functional lines in Alkermes research and development (R&D) and the broader organization. The primary role for the Senior Director, Translational Medicine is to provide expert TM opinion and direction across the organization, and to deliver and execute cohesive forward and back translational strategies that increase the probability of development success across Alkermes’ pipeline of projects and programs in psychiatry and neurology. The Senior Director will champion, generate and communicate goal-driven, scientific and technologically innovative cross-functional translational strategies, propose related clinical study designs, provide technical leadership to optimize implementation of translational assessments, and deliver timely and conclusive analyses of results from biomarkers, pharmacodynamic behavioral endpoints and other translational measures in clinical trials. In addition, this individual is expected to enhance Alkermes’ strategic translational capabilities and partnerships, pipeline strategy, support business development efforts and R&D processes. This is an intensely collaborative leadership role requiring proactive and cohesive integration with colleagues across all levels in research, development, clinical pharmacology, new product planning, biostatistics, project management, regulatory, legal, medical affairs, other functional areas and external partners

The successful candidate is expert in neuroscience and the landscape of central nervous system (CNS) therapeutics and has significant training and experience in neuroscience translational medicine and early clinical development. Successful experience implementing strategies for target engagement, proof-of-mechanism, patient stratification, pharmacodynamic response to treatment, disease progression and other clinical biomarker contexts of use is essential. 

Deep familiarity with early-stage (Phase 1 through proof-of-concept) clinical strategy and trial design, protocol review and authoring, statistical planning, vendor and study site management, operationalizing clinical biomarkers, analyzing biomarker data, and working in alignment with regulatory guidance related to biomarkers, first-in-human clinical trials and IND, NDA and other submissions is important for success in this role. 

This position also requires sophisticated skills for navigating a highly matrixed environment and an array of external R&D partners. Effective collaboration with stakeholders across internal functional lines, including clinical development, clinical operations, biostatistics, regulatory, medical affairs, discovery research and new product planning is critical. A proactive, entrepreneurial action-oriented work style and interpersonal soft skills are equally important. 

This individual will need to socialize and apply biomarker expertise and data to influence and inform decision-making in project teams and executive committees, confidently and expertly communicate biomarker strategies, and interpret and present biomarker results to guide clinical development, product differentiation and reverse-translation to support discovery research. 

• Provide expert TM strategic and tactical leadership to teams across all stages of R&D, in interactions with senior management, and in business development due diligence activities
• Contribute to strategic R&D pipeline discussions and research, clinical and corporate plans, including disease area and indication analyses and prioritization and Alkermes’ Artificial Intelligence strategy
• Create and deliver cross-functional, integrated TM biomarker strategies and early-stage clinical development plans in collaboration with project teams, leadership and external stakeholders
• Identify and develop productive, strategic partnerships with vendors, external thought leaders and investigators, and contribute to scientific and clinical advisory boards and investigator meetings
• Serve as TM lead for 2 or more R&D projects or programs in neurology and psychiatric disease areas
• Direct authorship contributions to TM strategy documents, clinical protocols, study reports, statistical analysis plans, regulatory documents (IB, IND, NDA, etc.), and external publications
• Responsible for TM elements of clinical study designs and protocols, technical excellence in biomarker operationalization, rigorous analysis of TM data from clinical trials, and budget management
• Implementation of biomarkers for target engagement, proof-of-mechanism, pharmacodynamic re