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.
Responsibilities
- 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, etc.) and publications
- Technical and operational excellence in biomarker and PD endpoint implementation
- Clinical trial data analysis (TM endpoints) and timely, decisive conclusions and recommendations
Qualifications
- Ph.D., Pharm.D., M.D., 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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About Us
Why join Team Alkermes?
Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A fully-integrated, global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients. Alkermes has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for various neurological disorders, including narcolepsy.
Beyond our important mission of developing medicines to address unmet patient needs, we actively seek to foster a culture of diversity, inclusion and belonging throughout our business. We strive to ensure that all voices are respected and valued, recognizing that our diversity of thought, background and perspective makes us stronger. We are proud to have been recognized as an employer of choice by many national organizations, including being certified as a Great Place to Work in the U.S. in 2024, honored as a Healthiest Employer in both Ohio and Massachusetts in 2023, a Best Place for Working Parents in 2023, and to have received the Bell Seal at the Platinum level for Workplace Mental Health by Mental Health America for three consecutive years (2021-2023).
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.
