We are seeking a highly motivated, strategic, and experienced neuroscience translational medicine expert to join as a key senior member of the Translational Medicine (TM) group in the Early Clinical Development line. This is an exciting, visible, and highly collaborative opportunity to apply your TM and broader R&D expertise and leadership skills toward achieving milestones for programs in neurology and psychiatry and influencing Alkermes’ R&D strategy.
The primary role for the Senior Director is to convert your expert TM strategic and tactical insight into scientific, actionable clinical plans and protocols to achieve program milestones and make data-driven decisions about molecules in development. Core responsibilities include designing and implementing clinical biomarker strategies for target engagement, PD response, and other contexts of use across programs and all Phases of clinical development; proactively integrating TM strategies with research, commercial, and other stakeholders’ goals; analyzing clinical trial data, influencing preclinical strategies, contributing to clinical study design, writing protocols, regulatory materials, and supporting business development due diligence activities.
Contribute to overall R&D strategic decisions, such as neuroscience areas of interest and investment in enabling technologies like AI-driven solutions to improve R&D processes
Identify and develop milestone-driven partnerships with vendors, external thought leaders, and investigators, and contribute to scientific and clinical advisory boards and investigator meetings
TM representative for a portfolio of clinical and preclinical stage programs in neurology and psychiatry with accountability for TM strategy, results and budget
Co-authoring clinical protocols, clinical study reports, statistical analysis plans, research partnerships, regulatory materials (IB, IND, NDA, and publications
Technical and operational excellence in biomarker and PD endpoint implementation
Clinical trial data analysis (TM endpoints) and timely, decisive conclusions and recommendations
., ., ., or equivalent advanced degree in neuroscience area or other biological or pharmacological sciences
Approximately 15 years post-graduate experience in pharmaceutical or biotech R&D, including several years in neuroscience therapeutic areas
Experience in TM and its roles and responsibilities in the context of a matrixed pharmaceutical company
Experience as TM leader on clinical stage drug development programs with track record of successful TM strategy development, implementation, analysis and impact on decision making
Ability to influence, negotiate and lead in a highly matrixed environment and with highly skilled and diverse colleagues
Business-minded and familiarity with values, roles and responsibilities of key stakeholders, including all areas of R&D, commercial, and external partners
Strong collaborative interpersonal skills and oral and written communication skills including presenting to executive leaders
Ability to manage scientific and business environment change and prioritize tasks
Up to date knowledge of regulatory guidance and processes affecting early clinical development and biomarker strategies
Biostatistical, bioinformatic or other data science analysis skills for analyzing complex clinical and other patient data is highly desirable
Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home. This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. This role is not eligible for fully remote work.
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